Full-Thickness Macular Hole Surgery: A Comparison of Ten Techniques
Vitreoretinal Surgery for Full-Thickness Macular Hole: A Comparative Study of Ten Techniques
Kazakh Eye Research Institute
120 participants
May 25, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria8
- Adults aged ≥18 years.
- Full-thickness macular hole (FTMH) eligible for pars plana vitrectomy (PPV).
- Symptom duration ≤12 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 Criteria14
- A. Etiology-Related / Secondary Macular Holes:
- Traumatic macular hole.
- High myopia with posterior staphyloma (axial length >28 mm and/or spherical equivalent ≤-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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Interventions
Pars plana vitrectomy (PPV) for full-thickness macular hole repair performed according to the randomized assigned technique (e.g., ERM peel, ILM peeling, ILM flap configurations, or macular edge hydrodissection), as specified in the protocol.
Autologous platelet-rich plasma (PRP) applied intraoperatively to the macular hole area as an adjunct to surgery, according to the study protocol.
Human amniotic membrane (hAM) graft placed intraoperatively for macular hole repair, according to the study protocol.
Locations(1)
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NCT07606404