Full-Thickness Macular Hole Surgery: A Comparison of Ten Techniques (NCT07606404) | Clinical Trial Compass
RecruitingNot Applicable
Full-Thickness Macular Hole Surgery: A Comparison of Ten Techniques
Kazakhstan120 participantsStarted 2026-05-25
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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 Criteria:
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.