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 range50 Years – 80 Years
SexALL
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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.
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