Lyophilized amniotic membrane patches are a safe and effective treatment for rhegmatogenous lesions in combined tractional and rhegmatogenous retinal detachment: A prospective interventional study

Abstract Objetives: This study was performed to evaluate the safety and effectiveness of a lyophilized amniotic membrane (LAM) as a patch for the treatment of retinal breaks and to describe the structural changes at the implantation site. Design: prospective, interventional study. Subjects: Patients with diabetic retinopathy and combined tractional and rhegmatogenous retinal detachment. Methods: Patients were organized into 3 groups according to the number of rhegmatogenous lesions: those in group A had a single break, those in group B had two breaks, and those in group C had three or more breaks. The location of the break was also evaluated as either superior or inferior. Main outcomes: Safety was evaluated and defined as a lack of adverse events or the absence of damage to the retinal tissue and intraocular structures. Efficacy was determined by evaluating SD-OCT images to assess whether complete coverage of the retinal break favouring the proximity of the edges and closure of the retinal break was achieved. Results: Of a total of 23 eyes of 23 patients, 22 (95.6%) achieved retinal repair without associated complications. Patients with 2 or fewer rhegmatogenous lesions located inthe superior sector had a better anatomical result as they achieved 100% surgical success. The structural changes observed by SD-OCT showed adequate adaptation of the lyophilized patch and complete closure of the rhegmatogenous lesion with no alterations in the adjacent tissue. Conclusions: The LAM patch seems to be safe and effective, as it promotes therapeutic closure of rhegmatogenous lesions without damaging the retinal architecture adjacent to the implantation site.