Safety and efficacy of human amniotic membrane plug transplantation in cases of macular hole. A scoping review.

Background: Recently, there has been a surge of literature utilizing the human amniotic membrane (hAM) to manage cases of macular holes. In this scoping review, we aimed to systematically narrate the literature to identify cases of macular holes that are managed using hAM and explore the visual and anatomical outcomes to inform future research questions.

Methods: This scoping review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A detailed database search strategy (Scopus, Embase, Medline, and Cochrane Central) was developed to identify English-language published articles that reported using hAM to manage macular holes. All human clinical studies were included for a narrative data synthesis divided across study types.

Results: The database search identified 82 articles, of which 34 were eligible for full-text review (0 randomized controlled trials (RCTs), 12 non-RCTs, 10 retrospective reviews, ten published case reports, and two clinical trial registries). The non-RCTs included patients with macular holes related to a wide range of retinal diseases, including retinal detachment, recurrent holes, and high myopia. Only two non-RCTs reported comparative data with a control group, but the study characteristics differed, and quantitative synthesis was impossible. Most retrospective interventional series and individual case reports reported a success rate of 93 -100% in hole closure and improvement in best-corrected visual acuity. None of the studies reported adverse effects after a hAM transplantation.

Conclusion: The hAM effectively seals macular holes without any safety concerns, improving anatomical and visual outcomes in all macular holes.