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

Recruiting now · Not applicable

Conditions studied: Macular Holes

In brief

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.

Key facts

Study ID

NCT07606404

Run by

Kazakh Eye Research Institute

People needed

120

Starts

2026-05-25

Expected to finish

2028-05-27

Last updated by the study team

2026-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Kazakh Eye Research Institute — Almaty, Almaty, Kazakhstan (enrolling)

Full record on ClinicalTrials.gov

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