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

RecruitingNAAges 18 Years - anyAllKazakh Eye Research Institute
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In plain words

What the trial is, and whether it could suit you

This study compares ten modern vitreoretinal surgical techniques for full-thickness macular hole repair. Participants will be randomly assigned to one of the surgical approaches during pars plana vitrectomy, using stratified randomization based on macular hole size to ensure balanced groups. The main goal is to determine which technique provides the highest anatomical closure rate on optical coherence tomography (OCT) and the best visual outcomes. Follow-up visits are scheduled at Day 7, Month 1, and Year 1 after surgery to assess OCT findings, visual acuity, safety outcomes, and the need for reoperation.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: Adults aged โ‰ฅ18 years. Full-thickness macular hole (FTMH) eligible for pars plana vitrectomy (PPV). Symptom duration โ‰ค12 months. Clear ocular media sufficient for high-quality OCT imaging. No prior pars plana vitrectomy in the study eye. No severe foveal atrophy on OCT. Able and willing to comply with postoperative positioning and follow-up visits. Written informed consent provided. Exclusion Criteria: A. Etiology-Related / Secondary Macular Holes: Traumatic macular hole. High myopia with posterior staphyloma (axial length \>28 mm and/or spherical equivalent โ‰ค-8.0 D). Diabetic tractional retinal detachment (TRD) or significant tractional maculopathy. Retinal vascular occlusion-related macular hole. Uveitis-related macular hole. Advanced age-related macular degeneration (AMD) with foveal atrophy. B. Prior Interventions: Any prior pars plana vitrectomy in the study eye. C. Ocular Conditions That May Affect Outcomes or Safety: Active or recent ocular infection or inflammation (e.g., uveitis, endophthalmitis, keratitis). Uncontrolled glaucoma (intraocular pressure \>28 mmHg despite treatment). Media opacity precluding adequate OCT (e.g., dense cataract or corneal opacity). Geographic atrophy involving the fovea.
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What it tests

  • Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery
  • Autologous Platelet-Rich Plasma (PRP)
  • Human Amniotic Membrane (hAM) Graft
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Where

1 site
Kazakh Eye Research Institute
Almaty, Kazakhstan
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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