To compare the morphologic and functional outcomes of internal limiting membrane
peeling-reposition versus peeling in idiopathic macular holes
Drug: Brilliant Blue G
Other: postoperative posture
Device: Constellation 23-gauge vitrectomy system
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Full eligibility criteria for NCT03020459
Ages eligible for Study
50 Years to 80 Years
Genders eligible for Study
Accepts Healthy Volunteers
The patients are diagnosed as macular hole by optical coherence tomography.
Age ranges from 50 to 80 years.
The patients have indication for surgery.
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
For reposition group, the patients will exit the research if the peeled ILM cannot
Due to adverse events, especially severe adverse events, the researchers consider
withdrawal of patients based on concerns of safety and ethics;
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.
All locations for NCT03020459
Shanghai, China, 200000
View full eligibility
Tris trial is registered with FDA with number: NCT03020459. The sponsor of the trial is Xinhua Hospital, Shanghai Jiao Tong University School of Medicine and it is looking for 30 volunteers for the current phase.
Official trial title: Comparing the Surgical Outcomes of Internal Limiting Membrane Peeling-reposition Versus Peeling in Idiopathic Macular Holes: A Randomized Controlled Trial
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