Effects of Topical Bromfenac Solution on Macular Thickness in Cataract Patients Undergoing Phacoemulsification Surgery

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Bromfenac drops may be effective in treating both acute and chronic pseudophakic CME. Objectives Evaluate the effects of the non–steroidal anti-inflammatory drug bromfenac 0.09% ophthalmic solution on macular thickness after phacoemulsification surgery and report any side effects. Method This is a prospective study done in an ophthalmic center in Iraq involving adult patients with senile or iatrogenic cataracts prepared for cataract surgery by phacoemulsification with intraocular lens (IOL) implantation and were divided into two groups: • Group one: who received 0.09% bromfenac ophthalmic solution twice daily in addition to Moxifloxacin 0.5% ophthalmic drops every 6hrs and Dexamethasone phosphate 0.1% ophthalmic drops every 4-6hrs post-operatively. • Group two: who received only Moxifloxacin 0.5% every 6 hours and Dexamethasone phosphate 0.1% ophthalmic drop every 4-6 hours without administering bromfenac 0.09% ophthalmic drops post-operatively. Results Eighty-seven eyes of 87 patients were enrolled in the study. The preoperative mean of central retinal thickness in groups one and two was 248.53±35.6μm and 262.40±20.7μm, respectively, with a p-value of 0.029. The postoperative mean of central retinal thickness in groups one and two was 255.78±36.6 μm and 278.18±29.06 μm, respectively, with a p-value of 0.004, which is clinically significant. The only side effect reported was punctate epithelial corneal erosion in five patients in group one. Conclusion This study demonstrated that bromfenac has shown significant efficacy in preventing cystoid macular edema (CME) following cataract surgery as compared to corticosteroids alone but might cause punctate epithelium corneal erosion in some patients. Clinical trial Trial number: NCT06785090 registration date: 2025-01-15 registration URL: https://clinicaltrials.gov/study/NCT06785090?cond=Cataract&rank=8 The registration was completed after the study commenced due to administrative and institutional requirements. As this trial was conducted as part of a master’s thesis, priority was given to obtaining ethical approval and ensuring compliance with institutional protocols, which led to an unintentional delay in registration. Once the importance of early registration for transparency and compliance was recognized, the process was promptly completed. 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F1000Research 2025, 14 :307 ( https://doi.org/10.12688/f1000research.162207.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Close Copy Citation Details Export Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente EXPORT Select a format first Track Share ▬ ✚ Research Article Effects of Topical Bromfenac Solution on Macular Thickness in Cataract Patients Undergoing Phacoemulsification Surgery [version 1; peer review: 1 approved with reservations] Enas Sabeeh Abdullah https://orcid.org/0009-0007-5538-7555 1 , Samara Mowafaq Ali https://orcid.org/0000-0001-7105-6966 2 , Zaid Rajab Hussein https://orcid.org/0009-0005-5128-0844 3 Enas Sabeeh Abdullah https://orcid.org/0009-0007-5538-7555 1 , Samara Mowafaq Ali https://orcid.org/0000-0001-7105-6966 2 , Zaid Rajab Hussein https://orcid.org/0009-0005-5128-0844 3 PUBLISHED 18 Mar 2025 Author details Author details 1 pharmacology, college of medicine - university of Baghdad, Baghdad, Baghdad, 10001, Iraq 2 pharmacology, college of medicine - university of Baghdad, Baghdad, Baghdad, 10001, Iraq 3 Retinal Department, Ibn Al Haitham Teaching Eye Hospital, Baghdad, Baghdad, 10001, Iraq Enas Sabeeh Abdullah Roles: Conceptualization, Formal Analysis, Funding Acquisition, Investigation, Project Administration, Resources, Software, Validation, Writing – Original Draft Preparation Samara Mowafaq Ali Roles: Data Curation, Formal Analysis, Investigation, Methodology, Project Administration, Supervision, Validation, Visualization, Writing – Review & Editing Zaid Rajab Hussein Roles: Data Curation, Investigation, Methodology, Project Administration, Supervision, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing OPEN PEER REVIEW DETAILS REVIEWER STATUS Abstract Background Although modern phacoemulsification is considered a highly safe surgery, cystoid macular edema (CME) is the common factor contributing to poor visual results following successful surgery. Bromfenac drops may be effective in treating both acute and chronic pseudophakic CME. Objectives Evaluate the effects of the non–steroidal anti-inflammatory drug bromfenac 0.09% ophthalmic solution on macular thickness after phacoemulsification surgery and report any side effects. Method This is a prospective study done in an ophthalmic center in Iraq involving adult patients with senile or iatrogenic cataracts prepared for cataract surgery by phacoemulsification with intraocular lens (IOL) implantation and were divided into two groups: • Group one: who received 0.09% bromfenac ophthalmic solution twice daily in addition to Moxifloxacin 0.5% ophthalmic drops every 6hrs and Dexamethasone phosphate 0.1% ophthalmic drops every 4-6hrs post-operatively. • Group two: who received only Moxifloxacin 0.5% every 6 hours and Dexamethasone phosphate 0.1% ophthalmic drop every 4-6 hours without administering bromfenac 0.09% ophthalmic drops post-operatively. Results Eighty-seven eyes of 87 patients were enrolled in the study. The preoperative mean of central retinal thickness in groups one and two was 248.53±35.6μm and 262.40±20.7μm, respectively, with a p-value of 0.029. The postoperative mean of central retinal thickness in groups one and two was 255.78±36.6 μm and 278.18±29.06 μm, respectively, with a p-value of 0.004, which is clinically significant. The only side effect reported was punctate epithelial corneal erosion in five patients in group one. Conclusion This study demonstrated that bromfenac has shown significant efficacy in preventing cystoid macular edema (CME) following cataract surgery as compared to corticosteroids alone but might cause punctate epithelium corneal erosion in some patients. Clinical trial Trial number: NCT06785090 registration date: 2025-01-15 registration URL: https://clinicaltrials.gov/study/NCT06785090?cond=Cataract&rank=8 The registration was completed after the study commenced due to administrative and institutional requirements. As this trial was conducted as part of a master’s thesis, priority was given to obtaining ethical approval and ensuring compliance with institutional protocols, which led to an unintentional delay in registration. Once the importance of early registration for transparency and compliance was recognized, the process was promptly completed. READ ALL READ LESS Keywords Bromfenac 0.09%, macular thickness, phacoemulsification Corresponding Author(s) Enas Sabeeh Abdullah ( [email protected] ) Close Corresponding author: Enas Sabeeh Abdullah Competing interests: No competing interests were disclosed. Grant information: The author(s) declared that no grants were involved in supporting this work. Copyright: © 2025 Sabeeh Abdullah E et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Sabeeh Abdullah E, Mowafaq Ali S and Rajab Hussein Z. Effects of Topical Bromfenac Solution on Macular Thickness in Cataract Patients Undergoing Phacoemulsification Surgery [version 1; peer review: 1 approved with reservations] . F1000Research 2025, 14 :307 ( https://doi.org/10.12688/f1000research.162207.1 ) First published: 18 Mar 2025, 14 :307 ( https://doi.org/10.12688/f1000research.162207.1 ) Latest published: 18 Mar 2025, 14 :307 ( https://doi.org/10.12688/f1000research.162207.1 ) Introduction The cataract is a degenerative alteration in the metabolism of the lens. 1 it is characterized by opacification 2 and clouding 3 of the transparent and crystalline lens inside the eyes, 4 which greatly impairs vision. 2 It is associated mainly with the aging process and is more common as people get older. 5 – 7 It can develop in either one or both eyes. 5 Despite being nearly always treatable, cataracts remain one of the primary indications of vision impairment globally and in Iraq. 5 , 8 Although modern phacoemulsification is considered highly safe, pseudophakic cystoid macular edema (CME) commonly contributes to poor visual results following successful surgery. 9 , 10 CME might be caused by cataract surgery, an intrusive operation that produces inflammatory mediators. These mediators flow from the anterior chamber to the posterior segment, leading to the disruption of blood-aqueous and blood-retinal barriers (BRB). CME results from fluid buildup in the retina due to the increased permeability of the perifoveal capillaries resulting from the disruption of the corneal retinal barrier (BRB). The increase in macular thickness following cataract surgery is well recognized as potentially resulting in CME. 11 Topical preparations, are the dosage forms that are most frequently chosen for the treatment of ocular diseases. They are a non-invasive method of administration. 12 Nonsteroidal anti-inflammatory drugs (NSAIDs) mainly exert their anti-inflammatory and analgesic effects by non-selectively inhibition of cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) enzymes by blocking the COX pathway and restrict arachidonic acid conversion to prostaglandins. The pivotal function of prostaglandins is to induce pain and facilitate miosis, vasodilation, leukocyte migration and disruption of the blood-ocular barrier. 13 Topical NSAIDs are more frequently utilized to avoid post-operative CME after cataract surgery and multiple meta-analyses on the role of NSAIDs like ketorolac, nepafenac, and diclofenac, have shown evidence of their effectiveness and proposed that their usage, either alone or in conjunction with topical steroids may be more advantageous than using steroids alone and their utility may also extend to the management of pseudophakic CME. 14 The sole brominated ophthalmic NSAID now available is bromfenac. 13 The presence of bromine in the chemical structure of bromfenac improves the molecule’s ability to dissolve in the blood and permeate the cornea, intraocular tissue and vitreous fluid. The bromination at the forth positions of the phenyl group prolongs the drug’s analgesic and anti-inflammatory effects. 15 This substance’s activity is mediated by its binding to and inhibition of cyclooxygenase II (COX II). Therefore, it prevents the transformation of arachidonic acid into cyclic endoperoxides, which serve as prostaglandins (PG) precursors. 16 Nonsteroidal anti-inflammatory drugs (NSAIDs) differ in their capacity to inhibit cyclooxygenases 1 and 2. While the precise plasma levels of bromfenac after ocular administration is unrecognized, its relative potency is evaluated by calculating the concentration of drug required to block 50% of the COX enzyme activity (inhibitory concentration 50% or IC50). A lower value for IC50 indicates a higher enzyme’s level of inhibition. Comparative in vitro experiments showed that bromfenac inhibits COX-2 18 times more potent than ketorolac, 6.5 times more potent than amfenac and 3.7 times more effective than diclofenac. 17 Bromfenac 0.09% has been approved by the US Food and Drug Administration (FDA) for use in cataract surgery patients to avoid ocular pain and minimize post-operative inflammation. 14 Aims of the study This study is designed to: 1- Evaluate the effects of the non–steroidal anti-inflammatory drug bromfenac 0.09% ophthalmic solution on macular thickness in post-operative cataract patients. 2- Report any adverse effects of 0.09% bromfenac ophthalmic solution on our patients. Clinical trial Trial number: NCT06785090 registration date: 2025-01-15 registration URL: https://clinicaltrials.gov/study/NCT06785090?cond=Cataract&rank=8 The registration was completed after the study commenced due to administrative and institutional requirements. As this trial was conducted as part of a master’s thesis, priority was given to obtaining ethical approval and ensuring compliance with institutional protocols, which led to an unintentional delay in registration. Once the importance of early registration for transparency and compliance was recognized, the process was promptly completed. Methods This prospective study was conducted in an Ophthalmic Center in Baghdad, Iraq, between May 2023 and January 2024. Eighty-seven (87) eyes were enrolled from eighty-seven (87) Iraqi patients diagnosed with cataracts. Ethical consideration and consent Ethical and scientific approvals were obtained from the Research Ethics Committee at the department of pharmacology, College of Medicine, university of Baghdad (ethical approval No.03-33 in 2024-9-17). Written informed consent was obtained from all participants before inclusion in the study. The study was conducted in accordance with the declaration of Helsinki. Patients selection criteria Inclusion criteria 1. All patients 18 years of age and older. 2. Patients diagnosed with cataracts. Exclusion criteria 1. Patients less than 18 years of age. 2. Patients with glaucoma, ocular hypertension, pseudo-exfoliation syndrome, or any optic nerve disease. 3. Patients with ocular diseases that might influence macular thickness, such as age-related macular degeneration, epiretinal membrane, history of uveitis, intraoperative complications, and traumatic cases. 4. Patients have undergone previous ocular surgery in the same eye, such as vitrectomy, intravitreal injection, retinal laser therapy, or corneal surgery 5. Patients who developed severe adverse effects from other drugs or had complications intraoperatively or postoperatively unrelated to bromfenac. 6. Patients take antiglaucoma medications. 7. Patients lost to follow-up. 8. Patients with an allergy to one of the postoperative medications. Eighty-seven Iraqi adult patients aged ≥ 18 years with iatrogenic senile cataracts were enrolled in this study. All patients had a full eye examination, which included a medical history reviewing, testing of visual acuity, slit-lamp examination, and intraocular pressure measurements. None of the patients had a history of an ocular condition or previous ocular surgery (glaucoma, uveitis, retinal disorders, central corneal opacities, etc.), or systemic diseases that could affect vision. Still, we include diabetic and hypertensive patients with no diabetic or hypertensive retinopathy. Those patients have undergone phacoemulsification surgery with intraocular lens (IOL) implantation and were divided into two groups: • Group one - consisted of forty-five patients who received 0.09% bromfenac ophthalmic solution twice daily in addition to Moxifloxacin 0.5% ophthalmic drops every 6hrs and Dexamethasone phosphate 0.1% ophthalmic drops every 4-6hrs. • Group two - consisted of forty-two patients who received only Moxifloxacin 0.5% every 6hrs and Dexamethasone phosphate 0.1% ophthalmic drops every 4-6hrs without the administration of bromfenac 0.09% ophthalmic drops. All the above drugs are used for six weeks with gradual tapering of steroids. Two experienced surgeons performed phacoemulsification surgery on all patients without intraoperative complications. The central retinal thickness (CRT) was measured pre-operatively and six weeks post-operatively by the same observer in both groups using Optical Coherence Tomography (OCT) 18 OPTOVUE SOLIX with two measurements of CRT. The mean value was recorded for analysis. All patients were followed up at one day, one week, and six weeks for any complications or side effects of any drug. Statistical analysis Data entry and analysis were conducted using Microsoft Excel 2019 and the Statistical Package for the Social Sciences (SPSS, Version 25). Frequencies and percentages were the main subjects of the descriptive analysis. Continuous variables were displayed as mean (standard deviation). The paired t -test was used to compare central retinal thickness, IOP, and BCVA before and after surgery in both groups. The Chi-squared test was employed for intergroup comparisons. In all analyses, p <0.05 was considered to indicate statistical significance. Results Eighty-seven Iraqi patients with cataracts were divided into two groups: group one (n=forty-five patients) underwent phacoemulsification surgery with the administration of bromfenac postoperatively, and group two (n=forty-two patients) underwent phacoemulsification surgery without administration of bromfenac post operatively. The demographic data between both groups show no significant differences between both groups regarding age, gender, diabetes mellitus, and hypertension, as shown in Table 1 . The average age of group one was 66.44±8.7 years ranging from 45 years to 86 years; 17 (37.7%) were in their 60s and 70s, more than half of the cases 25 (55.5%) were male, 27 (60%) had diabetes and 20 (44.4%) had hypertension, while group two had the mean age was 61.3±9.3 years ranging from 40 years to 76 years, 17 (40.4%) were in their 60s, 22 (52.3%) were female, 14 (33.3%) had diabetes and 19 (45.2%) had hypertension. Table 1. Patient demographic data. Variables Group one (n=45) Group two (n=42) P-value Age 40-49 1 (2.2%) 5 (11.9%) 0.344 50-59 9 (20%) 12 (28.5%) 60-69 17 (37.7%) 17 (40.4%) 70-79 17 (37.7%) 8 (19%) >80 1 (2.2%) 0 Gender Male 25 (55.5%) 20 (47.6%) 0.746 Female 20 (44.4%) 22 (52.3%) Diabetes Mellitus No 18 (40%) 28 (66.6%) 0.508 Yes 27 (60%) 14 (33.3%) Hypertension No 25 (55.5%) 23 (54.7%) 0.474 Yes 20 (44.4%) 19 (45.2%) For the central retinal thickness, the preoperative mean of CRT in group one and group two were 248.53±35.6 μm and 262.40±20.7 μm, respectively, with a p-value of 0.029, while the postoperative mean of CRT in group one and group two was 255.78±36.6 μm, 278.18±29.06 μm respectively with p-value was 0.004, and all these are clinically significant as shown in Table 2 . Table 2. Comparison of the central retinal thickness. Central retinal thickness μm Group one (n=45) Group two (n=42) P-value Preoperative 248.53±35.6 262.40±20.7 0.029 Postoperative 255.78±36.6 278.18±29.06 0.004 Table 3 illustrates the percentage changes of the CRT in the two groups post-operatively. Five patients (11.90%) had an increase of more than 100 μm in group two and none in group one. Those five patients had significant macular edema, four of them had diabetes, and two had hypertension. Table 3. The two groups' postoperative central retinal thickness deference. Difference Group one (n=45) Group two (n=42) Total (n=87) <0 μm 19 (42.22%) 4 (9.52%) 23 (26.44%) 0-50 μm 21 (46.67%) 28 (66.67%) 49 (56.32%) 51-100 μm 5 (11.11%) 5 (11.90%) 10 (11.49%) <100 μm 0 5 (11.90%) 5 (5.75%) Total 45 (100%) 42 (100%) 87 (100%) There were forty-one patients with diabetes, and the pre-operative mean of CRT was 257.74±74 μm and 264.07±34.65 μm, respectively, in group one and group two, with a p-value=0.983. For the postoperative CRT, the mean was 266.6±39.4 μm and 287.6±37.4 μm, respectively, in group one and group two, with a p-value=0.042, which was clinically significant, as shown in Table 4 . Table 4. Changes of central retinal thickness in diabetes patients. Central retinal thickness μm Group one (n=27) Group two (n=14) P-value Preoperative 257.74 ± 74 264.07 ± 34.65 0.983 Postoperative 266.6 ± 39.4 287.6 ± 37.4 0.042 There were thirty-nine patients with hypertension, and the pre-operative means of CRT were 241.80±42.85 μm and 260.36±25.72 μm, respectively, in groups one and two with p-value=0.218, while for the postoperative CRT, the mean was 251.8±38.8 μm, 276.5±32.6 μm respectively in group one and two with p-value=0.022 which are also clinically significant as shown in Table 5 . Table 5. Changes of central retinal thickness in patients with hypertension. Central retinal thickness μm Group one (n=20) Group two (n=19) P-Value Preoperative 241.80±42.85 260.36±25.72 0.218 Postoperative 251.8 ±38.8 276.5 ± 32.6 0.022 There were forty-five males in this study, and the pre-operative mean of CRT was 243.96±36.79 μm and 260.7±17.18 μm, respectively, in group one and group two, with a p-value=0.090. The postoperative mean of CRT was 245.2±31.9 μm and 273.99±24.1 μm, respectively, in group one and group two, with a p-value=0.016, which are clinically significant, as shown in Table 6 . Table 6. Changes in central retinal thickness in male. Central retinal thickness μm Group one (n=25) Group two (n=20) P-Value Preoperative 243.96±36.79 260.7±17.18 0.090 Postoperative 245.2±31.9 273.99±24.1 0.016 Regarding the females, there were forty-two females. The pre-operative mean of CRT was 254.25±34.11 μm, and 263.95±26.37 μm respectively, in group one and group two with p-value=0.099, while the post-operative mean of CRT was 268.2±38.9 μm and 287.62±37.4 μm respectively in group one and group two with p-value=0.047 which are also clinically significant as shown in Table 7 . Table 7. Changes of central retinal thickness in female. Central retinal thickness μm Group one (n=20) Group two (n=22) P-Value Preoperative 254.25±34.11 263.95±26.37 0.099 Postoperative 268.2±38.9 287.62±37.4 0.047 Five patients in group one developed Punctuate Epithelial Erosions (PEE) or Superficial Punctate Keratitis (SPK) post-operatively. At the same time, there were no patients with corneal changes in group two, and no other side effects were reported. Five patients developed cystoid macular edema in group two as a complication of phacoemulsification surgery, and no cystoid macular edema was noted in group one. Discussion Postoperatively, both groups exhibited a rise in central retinal thickness (CRT), as seen in Table 2 . Nevertheless, group two experienced a more pronounced rise, and the difference remained statistically significant. The observed increase in CRT in the group that did not receive bromfenac can be attributed to the inflammatory process following cataract surgery, which is a predisposing factor for the occurrence of CME. 19 A mechanical trauma-induced series of inflammatory processes, resulting in the production of prostaglandins (PGs) and other inflammatory mediators in the anterior segment, characterizes the pathophysiology of post-operative CME. The inflammatory Mediators induce the disruption of the blood-retinal barrier, causing the buildup of fluid within the retina and thickening and swelling of the macular tissue. Furthermore, prostaglandins in the eye induce vasodilation and leukocyte migration. 20 Among group one, Bromfenac probably inhibited the postoperative inflammatory process. This explanation aligns with the findings of Song SH et al. whose study demonstrated that NSAIDs, including bromfenac, are frequently used before and after cataract surgery to mitigate macular edema due to their analgesic, anti-inflammatory, anticoagulant and antipyretic characteristics. Bromfenac specifically blocks COX-2, the primary enzyme responsible for eye inflammation. Its enhanced lipophilic properties enable it to penetrate the cornea more effectively, leading to faster and efficacious analgesic and anti-inflammatory effects relative to other NSAID ophthalmic drops. 15 Table 3 presents data indicating a 5.75% incidence of a significant increment in CRT of higher than 100 μm and CME, which aligns with the results reported by De Almeida L et al., who reported a 6.4% occurrence. 10 Nevertheless, another study suggested that the prevalence of CME in the general population varies between 0.1% and 2.35%, usually occurring 4 to 6 weeks after the surgery. 21 Other studies have demonstrated a broader range in the prevalence of CME, ranging from 0.2% to 20%. 22 This variability is probably influenced by whether the diagnosis was established by clinical examination or verified using fluorescein angiography or optical coherence tomography (OCT). 10 , 22 Other variables that affect the prevalence of CME following the surgery of cataract include surgical techniques and the presence of related comorbidities. 10 Also, all the patients who had CME were in group two, and none in group one, which indicates the protective effect of bromfenac in preventing CME. Diabetes mellitus (DM) is the most common metabolic condition. 23 In the industrialized world, it is one of the leading causes of vision loss. 24 Among the general population, type 2 diabetes is more common (95%) than type I diabetes (5%). 25 and the data presented in Table 4 indicates a significant difference between the two groups. Group one had a lower mean central retinal thickness postoperatively (266.6 μm) than group two (287.6 μm), with a statistically significant difference (p-value=0.042). These findings indicate that bromfenac could be efficacious in decreasing the thickness of the central retina after surgery in individuals with diabetes. This goes in line with the previous studies that indicate that the administration of a steroid ophthalmic solution alone in post-cataract surgery is inadequate for preventing macular edema in diabetic patients and should be augmented with NSAIDs. 15 Table 5 shows that group one had a lower mean central retinal thickness postoperatively (251.8 μm) compared to group two (276.5 μm) with a p-value equal to 0.022. This suggests that bromfenac might effectively reduce central retinal thickness postoperatively in hypertensive patients. Ocular alterations in people with very high blood pressure can be substantial and encompass optic neuropathy, retinopathy and choroidopathy. 26 Although most studies do not specifically target hypertensive patients, the general results indicate that bromfenac’s effectiveness in decreasing retinal thickness and preventing cystoid macular edema (CME) can be advantageous for various patient groups, including those with hypertension. In both males and females, Tables 6 and 7 show that Group 2 consistently experienced a greater increase in CRT postoperatively compared to Group 1, with both groups showing a statistically significant difference postoperatively. The differences were not statistically significant preoperatively in either gender, meaning the groups were relatively comparable before surgery. The statistically significant increase in Group Two’s CRT postoperatively in both genders may suggest that this group experienced more inflammation, potentially due to surgery, 19 and the absence of preventive treatment by bromfenac. This pattern supports the hypothesis that bromfenac, which reduces inflammation, may help in limiting CRT increase and preventing conditions like cystoid macular edema 15 regardless of the gender. Studies have shown that males and females can have different baseline retinal thicknesses and responses to ocular treatments due to hormonal and anatomical differences. Males also have greater foveal and mean macular thickness. 27 , 28 In this study, female patients experienced a larger increase in CRT than male patients. However, the sample size is not large enough to be representative of the general population. Five patients from group one had Punctate Epithelial Erosions (PEE), also known as Superficial Punctate Keratitis (SPK), and many studies reported corneal toxicity from NSAID, especially when combined with steroids. 29 , 30 Conclusion This study demonstrated that bromfenac has shown significant efficacy in preventing cystoid macular edema (CME) following cataract surgery as compared to corticosteroids alone but might cause punctate epithelium corneal erosion in some patients. Ethical consideration and consent The study was conducted based on the declaration of Baghdad University’s Ethical Committee, College of Medicine, and according to the ministry of health ethical policy (ethical permission letter No.03-33 in 2024-9-17). Written informed consent was obtained from all participants before inclusion in the study. The study was conducted in accordance with the Helsinki Treaty. Reporting guidelines • CONSORT Checklist and Trial Protocol for the Study ‘Effects of Bromfenac on Macular Thickness After Phacoemulsification Surgery’ • DOI : 10.5281/zenodo.14963441 31 • License : Creative Commons Attribution 4.0 International (CC BY 4.0) Data availability The data underlying this study are available in Zenodo: data of patients (with and withoutbromfenac) . https://doi.org/10.5281/zenodo.14318557 . 32 The project contains the following underlying data: - [ groop with .xlsx ] (Raw data of patients who received bromfenac). - [ groop without.xlsx ] (Raw data of patients who did not receive bromfenac). Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0). References 1. 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PubMed Abstract | Publisher Full Text 27. Jerotic S, Lalovic N, Pejovic S, et al. : Sex differences in macular thickness of the retina in patients with psychosis spectrum disorders. Prog. Neuro-Psychopharmacol. Biol. Psychiatry. 2021; 110 : 110280. PubMed Abstract | Publisher Full Text 28. Kashani AH, Zimmer-Galler IE, Shah SM, et al. : Retinal thickness analysis by race, gender, and age using Stratus OCT. Am. J. Ophthalmol. 2010; 149 (3): 496–502.e1. PubMed Abstract | Publisher Full Text | Free Full Text 29. Lee JS, Kim YH, Park YM: The toxicity of nonsteroidal anti-inflammatory eye drops against human corneal epithelial cells in vitro. J. Korean Med. Sci. 2015; 30 (12): 1856–1864. PubMed Abstract | Publisher Full Text | Free Full Text 30. Raj N, Panigrahi A, Alam M, et al. : Bromfenac-induced neurotrophic keratitis in a corneal graft. BMJ Case Reports CP. 2022; 15 (7): e249400.31. sabeeh enas. data of patients (with and without bromfenac). Zenodo; 2024. Publisher Full Text 31. Sabeeh E, Alabdali SM, Hussein ZR: CONSORT Checklist and Trial Protocol for the Study ‘Effects of Bromfenac on Macular Thickness After Phacoemulsification Surgery’. Zenodo. 2025. Publisher Full Text 32. Sabeeh E, Alabdali SM, Hussein ZR: Data of patients (with and without bromfenac). Publisher Full Text Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 18 Mar 2025 ADD YOUR COMMENT Comment Author details Author details 1 pharmacology, college of medicine - university of Baghdad, Baghdad, Baghdad, 10001, Iraq 2 pharmacology, college of medicine - university of Baghdad, Baghdad, Baghdad, 10001, Iraq 3 Retinal Department, Ibn Al Haitham Teaching Eye Hospital, Baghdad, Baghdad, 10001, Iraq Enas Sabeeh Abdullah Roles: Conceptualization, Formal Analysis, Funding Acquisition, Investigation, Project Administration, Resources, Software, Validation, Writing – Original Draft Preparation Samara Mowafaq Ali Roles: Data Curation, Formal Analysis, Investigation, Methodology, Project Administration, Supervision, Validation, Visualization, Writing – Review & Editing Zaid Rajab Hussein Roles: Data Curation, Investigation, Methodology, Project Administration, Supervision, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Competing interests No competing interests were disclosed. Grant information The author(s) declared that no grants were involved in supporting this work. Article Versions (1) version 1 Published: 18 Mar 2025, 14:307 https://doi.org/10.12688/f1000research.162207.1 Copyright © 2025 Sabeeh Abdullah E et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Download Export To Sciwheel Bibtex EndNote ProCite Ref. Manager (RIS) Sente metrics Views Downloads F1000Research - - PubMed Central info_outline Data from PMC are received and updated monthly. - - Citations open_in_new 0 open_in_new 0 open_in_new SEE MORE DETAILS CITE how to cite this article Sabeeh Abdullah E, Mowafaq Ali S and Rajab Hussein Z. Effects of Topical Bromfenac Solution on Macular Thickness in Cataract Patients Undergoing Phacoemulsification Surgery [version 1; peer review: 1 approved with reservations] . F1000Research 2025, 14 :307 ( https://doi.org/10.12688/f1000research.162207.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS track receive updates on this article Track an article to receive email alerts on any updates to this article. TRACK THIS ARTICLE Share Open Peer Review Current Reviewer Status: ? Key to Reviewer Statuses VIEW HIDE Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Version 1 VERSION 1 PUBLISHED 18 Mar 2025 Views 0 Cite How to cite this report: Ricci GD and Belcastro E. Reviewer Report For: Effects of Topical Bromfenac Solution on Macular Thickness in Cataract Patients Undergoing Phacoemulsification Surgery [version 1; peer review: 1 approved with reservations] . F1000Research 2025, 14 :307 ( https://doi.org/10.5256/f1000research.178365.r381164 ) The direct URL for this report is: https://f1000research.com/articles/14-307/v1#referee-response-381164 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 10 May 2025 Giuseppe D'Amico Ricci , Turin Eye Hospital, Turin, Italy Elena Belcastro , Ophthalmology, Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino, Turin, Piedmont, Italy Approved with Reservations VIEWS 0 https://doi.org/10.5256/f1000research.178365.r381164 This prospective study in an Iraqi ophthalmic center assessed whether adding bromfenac 0.09% drops to standard postoperative care affects macular thickness after phacoemulsification. The authors enrolled 87 adult patients (one eye each) undergoing cataract surgery. Patients were described as having ... Continue reading READ ALL This prospective study in an Iraqi ophthalmic center assessed whether adding bromfenac 0.09% drops to standard postoperative care affects macular thickness after phacoemulsification. The authors enrolled 87 adult patients (one eye each) undergoing cataract surgery. Patients were described as having “iatrogenic senile cataracts”, although the abstract inconsistently refers to “senile or iatrogenic” cataracts. Subjects were divided into two groups: one group (n=45) received bromfenac twice daily plus moxifloxacin and dexamethasone drops after surgery, and the control group (n=42) received only moxifloxacin and dexamethasone. Central retinal thickness (CRT) was measured by optical coherence tomography (OCT) before surgery and at six weeks postoperatively. Key findings were that the bromfenac group had a significantly smaller increase in CRT. Preoperative mean CRTs were 248.5 ± 35.6 μm (bromfenac) versus 262.4 ± 20.7 μm (control) (p=0.029), and at six weeks 255.8 ± 36.6 μm versus 278.2 ± 29.1 μm (p=0.004). Notably, five patients in the control group (11.9%) showed >100 μm increase in CRT (suggestive of cystoid macular edema, CME) versus none in the bromfenac group. The only reported adverse effect was punctate corneal epithelial erosion in 5/45 patients on bromfenac. The authors conclude that bromfenac significantly prevents postoperative CME compared to steroid alone, albeit with a risk of corneal erosion. Clarity and Literature: The manuscript is generally clear and cites relevant literature on cataract surgery and NSAID use. The introduction includes recent reviews and comparisons of NSAIDs (e.g. refs. 14–17 in the paper).. However, terminology is inconsistent: the abstract’s phrase “senile or iatrogenic cataracts” conflicts with the methods’ “iatrogenic senile cataracts”. Clarification of this term is needed. The current literature on NSAIDs and CME is appropriately referenced, suggesting the authors are aware of established findings. Study Design and Methods: The prospective design and focus on a clinically relevant question give the work merit. Inclusion/exclusion criteria are listed (though excluding any prior ocular surgery or trauma makes the term “iatrogenic cataract” puzzling). Randomization or allocation methods are not described, which limits assessment of potential bias. The surgical procedure and postoperative regimens are sufficiently detailed for replication. Data collection methods (OCT measurement of CRT by a single observer) are described, which aids reproducibility. Statistical Analysis: The authors report using paired t-tests for before/after comparisons and chi-squared tests for between-group categorical comparisons. However, they do not report checking the normality assumption required for t-tests. Given the modest sample sizes, it would be prudent to test for normal distribution or consider non-parametric alternatives (e.g. Wilcoxon tests) if normality is violated. This omission means the statistical validity is only partially assured. The reported p-values (e.g. p=0.004 for CRT difference) appear correctly calculated, but without normality checks the confidence in the parametric tests is reduced. Data Availability: The authors have made the raw data publicly available via Zenodo, which is commendable and supports reproducibility. All source data (patient measurements with/without bromfenac) are accessible under a CC BY license. Conclusions: The conclusion that bromfenac effectively reduces postoperative CRT (and thus likely prevents CME) is supported by the results. The noted corneal toxicity in a minority of patients also matches the reported 11% incidence of erosions. Overall, the conclusions follow from the data, but should be tempered by acknowledging the small sample and lack of blinding or randomization. Specific Issues and Recommendations: Terminology and Consistency: The abstract and main text use inconsistent descriptors for the cataract type, which should be harmonized. The meaning of “iatrogenic cataract” needs clarification or should be replaced with “age-related” or another appropriate term, since patients with prior ocular interventions were excluded. Statistical Assumptions: The authors should verify and report whether CRT differences follow a normal distribution. If not, appropriate non-parametric tests (e.g. Wilcoxon Signed-Rank or Mann–Whitney U test) should be used or at least mentioned. Group Assignment: The manuscript does not specify whether patients were randomized or how groups were formed. This should be clarified to assess potential selection bias. Consistency of Presentation: The inconsistency between abstract and text regarding cataract types undermines clarity and should be corrected. All reported outcomes (e.g. IOP, BCVA if measured) should be consistently included or explained if omitted. Minor Clarifications: Spell out acronyms at first use (e.g. CME) and ensure units and statistical terms are explained. In summary, the study addresses a relevant clinical question with generally sound methodology, and the data support the main claims. The reporting is mostly clear, but the above points should be addressed to enhance rigor and clarity. Is the work clearly and accurately presented and does it cite the current literature? Partly Is the study design appropriate and is the work technically sound? Partly Are sufficient details of methods and analysis provided to allow replication by others? Yes If applicable, is the statistical analysis and its interpretation appropriate? Partly Are all the source data underlying the results available to ensure full reproducibility? Yes Are the conclusions drawn adequately supported by the results? Yes Competing Interests: No competing interests were disclosed. Reviewer Expertise: Vitreoretinal Surgery, Anterior segment surgery, Ophthalmology . We confirm that we have read this submission and believe that we have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however we have significant reservations, as outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Ricci GD and Belcastro E. Reviewer Report For: Effects of Topical Bromfenac Solution on Macular Thickness in Cataract Patients Undergoing Phacoemulsification Surgery [version 1; peer review: 1 approved with reservations] . F1000Research 2025, 14 :307 ( https://doi.org/10.5256/f1000research.178365.r381164 ) The direct URL for this report is: https://f1000research.com/articles/14-307/v1#referee-response-381164 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 18 Mar 2025 ADD YOUR COMMENT Comment keyboard_arrow_left keyboard_arrow_right Open Peer Review Reviewer Status info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Reviewer Reports Invited Reviewers 1 Version 1 18 Mar 25 read Giuseppe D'Amico Ricci , Turin Eye Hospital, Turin, Italy Elena Belcastro , Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino, Turin, Italy Comments on this article All Comments (0) Add a comment Sign up for content alerts Sign Up You are now signed up to receive this alert Browse by related subjects keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2025 Ricci G et al. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 10 May 2025 | for Version 1 Giuseppe D'Amico Ricci , Turin Eye Hospital, Turin, Italy Elena Belcastro , Ophthalmology, Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino, Turin, Piedmont, Italy 0 Views copyright © 2025 Ricci G et al. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions This prospective study in an Iraqi ophthalmic center assessed whether adding bromfenac 0.09% drops to standard postoperative care affects macular thickness after phacoemulsification. The authors enrolled 87 adult patients (one eye each) undergoing cataract surgery. Patients were described as having “iatrogenic senile cataracts”, although the abstract inconsistently refers to “senile or iatrogenic” cataracts. Subjects were divided into two groups: one group (n=45) received bromfenac twice daily plus moxifloxacin and dexamethasone drops after surgery, and the control group (n=42) received only moxifloxacin and dexamethasone. Central retinal thickness (CRT) was measured by optical coherence tomography (OCT) before surgery and at six weeks postoperatively. Key findings were that the bromfenac group had a significantly smaller increase in CRT. Preoperative mean CRTs were 248.5 ± 35.6 μm (bromfenac) versus 262.4 ± 20.7 μm (control) (p=0.029), and at six weeks 255.8 ± 36.6 μm versus 278.2 ± 29.1 μm (p=0.004). Notably, five patients in the control group (11.9%) showed >100 μm increase in CRT (suggestive of cystoid macular edema, CME) versus none in the bromfenac group. The only reported adverse effect was punctate corneal epithelial erosion in 5/45 patients on bromfenac. The authors conclude that bromfenac significantly prevents postoperative CME compared to steroid alone, albeit with a risk of corneal erosion. Clarity and Literature: The manuscript is generally clear and cites relevant literature on cataract surgery and NSAID use. The introduction includes recent reviews and comparisons of NSAIDs (e.g. refs. 14–17 in the paper).. However, terminology is inconsistent: the abstract’s phrase “senile or iatrogenic cataracts” conflicts with the methods’ “iatrogenic senile cataracts”. Clarification of this term is needed. The current literature on NSAIDs and CME is appropriately referenced, suggesting the authors are aware of established findings. Study Design and Methods: The prospective design and focus on a clinically relevant question give the work merit. Inclusion/exclusion criteria are listed (though excluding any prior ocular surgery or trauma makes the term “iatrogenic cataract” puzzling). Randomization or allocation methods are not described, which limits assessment of potential bias. The surgical procedure and postoperative regimens are sufficiently detailed for replication. Data collection methods (OCT measurement of CRT by a single observer) are described, which aids reproducibility. Statistical Analysis: The authors report using paired t-tests for before/after comparisons and chi-squared tests for between-group categorical comparisons. However, they do not report checking the normality assumption required for t-tests. Given the modest sample sizes, it would be prudent to test for normal distribution or consider non-parametric alternatives (e.g. Wilcoxon tests) if normality is violated. This omission means the statistical validity is only partially assured. The reported p-values (e.g. p=0.004 for CRT difference) appear correctly calculated, but without normality checks the confidence in the parametric tests is reduced. Data Availability: The authors have made the raw data publicly available via Zenodo, which is commendable and supports reproducibility. All source data (patient measurements with/without bromfenac) are accessible under a CC BY license. Conclusions: The conclusion that bromfenac effectively reduces postoperative CRT (and thus likely prevents CME) is supported by the results. The noted corneal toxicity in a minority of patients also matches the reported 11% incidence of erosions. Overall, the conclusions follow from the data, but should be tempered by acknowledging the small sample and lack of blinding or randomization. Specific Issues and Recommendations: Terminology and Consistency: The abstract and main text use inconsistent descriptors for the cataract type, which should be harmonized. The meaning of “iatrogenic cataract” needs clarification or should be replaced with “age-related” or another appropriate term, since patients with prior ocular interventions were excluded. Statistical Assumptions: The authors should verify and report whether CRT differences follow a normal distribution. If not, appropriate non-parametric tests (e.g. Wilcoxon Signed-Rank or Mann–Whitney U test) should be used or at least mentioned. Group Assignment: The manuscript does not specify whether patients were randomized or how groups were formed. This should be clarified to assess potential selection bias. Consistency of Presentation: The inconsistency between abstract and text regarding cataract types undermines clarity and should be corrected. All reported outcomes (e.g. IOP, BCVA if measured) should be consistently included or explained if omitted. Minor Clarifications: Spell out acronyms at first use (e.g. CME) and ensure units and statistical terms are explained. In summary, the study addresses a relevant clinical question with generally sound methodology, and the data support the main claims. The reporting is mostly clear, but the above points should be addressed to enhance rigor and clarity. Is the work clearly and accurately presented and does it cite the current literature? Partly Is the study design appropriate and is the work technically sound? Partly Are sufficient details of methods and analysis provided to allow replication by others? Yes If applicable, is the statistical analysis and its interpretation appropriate? Partly Are all the source data underlying the results available to ensure full reproducibility? Yes Are the conclusions drawn adequately supported by the results? Yes Competing Interests No competing interests were disclosed. Reviewer Expertise Vitreoretinal Surgery, Anterior segment surgery, Ophthalmology . We confirm that we have read this submission and believe that we have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however we have significant reservations, as outlined above. reply Respond to this report Responses (0) Ricci GD and Belcastro E. Peer Review Report For: Effects of Topical Bromfenac Solution on Macular Thickness in Cataract Patients Undergoing Phacoemulsification Surgery [version 1; peer review: 1 approved with reservations] . F1000Research 2025, 14 :307 ( https://doi.org/10.5256/f1000research.178365.r381164) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. 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