The protective effect of Vitamin A Palmitate Eye Gel on ocular surface during general anesthesia surgery: a randomized clinical trial

Abstract Background: General anesthesia was associated with tear production decreased, usually accompanied by ophthalmological complications, such as dry eye and corneal injuries. Patients suffering from such conditions developed symptoms such as conjunctival injection, eye pain, and tearing. Protective measures including taping eyelid closed and applying lubricating tears during general anesthesia have long been advocated to reduce the incidence of corneal abrasion. The study aimed to investigate the change of tear production associated with general anesthesia, and the protective effect of Vitamin A Palmitate Eye Gel on ocular surface during general anesthesia, including the subjective symptoms and objective signs. Methods: The study was designed as a double-blind randomized clinical trial. Each participant who was ready for non-ophthalmic general anesthesia surgery randomly received Vitamin A Palmitate Eye Gel and taping for one eye (Group A, n=60), and taping alone for the other eye (Group B, n=60) though random number table. Symptom assessment in dry eye (SANDE) score, tear film break-up time (TBUT), corneal fluorescein staining (CFS) score and Schirmer tear test I (STT-1) were assessed under hand-held slit lamp before anesthesia (T0), 0.5h postoperative (T1) and 24h postoperative (T2). Results: At 0.5h postoperative, both groups demonstrated increase in CFS score (P<0.05 in Group A and P<0.01 in Group B), and the participants in Group A showed numerically less corneal abrasion than that of in Group B. STT-1 observed in Group A was statistically increased (P<0.05), while that of in Group B was statistically decreased (P<0.001). The changes between two groups were statistically significant (P<0.001). At 24h postoperative, both CFS score and STT-1 almost returned to baseline level in two groups. SANDE score and TBUT showed little change at 0.5h and 24h postoperative in two groups (P>0.05). Conclusion: Vitamin A Palmitate Eye Gel were effective in ocular surface protection and aqueous supplementation during general anesthesia. Trial registration: The study was registered with the Chinese Clinical Trial Registry (ChiCTR2100052140). Registered 20 October,2021. http://www.chictr.org.cn/showproj.aspx?proj=135706 Trial registration: ISRCTN, ISRCTN12345678., http://www.isrctn.com/ISRCTN12345678