Comparing Ten Surgical Techniques for Full-Thickness Macular Hole Repair Using Pars Plana Vitrectomy

What this Trial Is About

Researchers are evaluating ten different vitreoretinal surgical techniques for repairing full-thickness macular holes, a condition that threatens vision. This study aims to identify which surgical method leads to the highest rate of hole closure as seen on optical coherence tomography OCT and the best visual outcomes. The trial includes adults with varying sizes of macular holes and uses stratified randomization based on hole size to balance participant groups. The study involves pars plana vitrectomy PPV procedures with various approaches, such as internal limiting membrane ILM peeling, different ILM flap configurations, adjunct use of autologous platelet-rich plasma PRP, human amniotic membrane hAM grafts, and macular edge hydrodissection. Participants are randomly assigned to one of the ten surgical techniques. Postoperative care and follow-up are standardized across all groups. Participants will have follow-up visits on Day 7, Month 1, and Year 1 after surgery to undergo clinical exams and OCT imaging to assess macular hole closure, visual acuity, and safety outcomes including complications and reoperations. The study will measure anatomical closure on OCT at these time points as the primary outcome, along with secondary outcomes like best-corrected visual acuity and morphological recovery. Safety and adverse events will be monitored through the first year post-surgery.

Full-Thickness Macular Hole Surgery: A Comparison of Ten Techniques