Internal Limiting Membrane Peeling-reposition to Treat Idiopathic Macular Holes
China30 participantsStarted 2017-01-01
Plain-language summary
To compare the morphologic and functional outcomes of internal limiting membrane peeling-reposition versus peeling in idiopathic macular holes
Who can participate
Age range
50 Years – 80 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:
* The patients are diagnosed as macular hole by optical coherence tomography.
* Age ranges from 50 to 80 years.
* The patients have indication for surgery.
Exclusion Criteria:
* Traumatic macular hole.
* Combined with serious epiretinal membrane.
* Combined with diabetic retinopathy, hypertensive retinopathy.
* Combined with other ocular diseases, such as keratitis，uveitis，retinal vasculitis.
* \- 6.0 diopters or more of spherical equivalent, 26mm or more of axial length.
* History of intraocular surgery.
* Presence of staphyloma.
* Other ocular diseases that could influence macular microstructure or visual function
Exit criteria:
* For reposition group, the patients will exit the research if the peeled ILM cannot reposition successfully.
* Due to adverse events, especially severe adverse events, the researchers consider withdrawal of patients based on concerns of safety and ethics;
* Drop out;
* The patients voluntarily withdraw the informed consent;
* Serious violation of the study protocol due to the subjects or investigators' reasons;
* Other reasons that the researchers believe for quitting the study.
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
1
Best corrected visual acuity(BCVA)
Timeframe: Pre-operation and 6 months after operation
Trial details
NCT IDNCT03020459
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine