UnknownNot Applicable

To Evaluate the Therapeutic Efficacy of Hydrated Amniotic Membrane in Promoting Closure of Refractory Macular Holes.

China80 participantsStarted 2022-06-01

Plain-language summary

To compare anatomic and functional results, and to evaluate postoperatively the healing process in 3 different techniques for the closure of the refractory macular holes (MH).

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

. idiopathic macular hole was defined as macular hole diameter (with no history of secondary macular hole) larger than 800μm in minimum linear diameter ;
. Patients with an idiopathic macular hole submitted to pars plana vitrectomy with internal limiting membrane peeling treatment without closing it and macular hole diameter larger than 200μm.

Exclusion criteria

. idiopathic macular hole diameter less than 800μm in minimum linear diameter;
. Macular hole caused by trauma and laser;
. Macular holes secondary to another vitreoretinal diseases;
. Macular hole of pathological myopia (axial length ≥26.0mm and diopter ≥6.00D，posterior scleral staphyloma，the atrophic choroid and retina with scleral exposure);
. Known to be allergic to amniotic membrane.
. Patients with other ocular disease (diabetic retinopathy, glaucoma, uveitis, ocular tumors, etc);
. Macular hole of other causes (secondary)；
. History of vitreoretinal surgery for a condition other than the idiopathic macular hole (retinal detachment, vitreous hemorrhage);

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.

What they're measuring

Rate of Anatomic closure

Timeframe: Month 6 post operative

Reconstruction of the foveal layered retinal structure change

Timeframe: Month 1, 3, 6 post-operative

Trial details

NCT IDNCT05396209

SponsorOriental Neurosurgery Evidence-Based-Study Team

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-15

Contact for this trial

Qihua Wang, MD

86-10-18601180961 wqha01696@btch.edu.cn

View on ClinicalTrials.gov More Macular Holes trials