An interventional study of Translocation ILM Flap and ILM Peeling in Macular Holes, sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. Recruiting at 1 site in China. Open to participants aged 55 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-10-30.
Sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Not applicable, Interventional, and Treatment
The main objective of this study is to evaluate the therapeutic effectiveness of the internal limiting membrane (ILM) peeling and translocation surgery compared to the conventional surgical approach for treating large idiopathic macular hole (IMH) through a well-designed prospective randomized controlled clinical trial. This study aims to compare the new surgical approach to the conventional approach in terms of improving visual function, promoting macular retinal anatomical healing, and enhancing patients' quality of life. By conducting this prospective clinical trial, establishing a database, and generating clinical reports and evidence-based medicine on the therapeutic efficacy of the ILM peeling and translocation surgery for large IMH.
139 studies on the registry are indexed under Retinal Perforations; 22 are open to participants now.
This study's planned enrollment of 76 is above the median of 50 across 94 interventional studies indexed under Retinal Perforations.
Browse Retinal Perforations studies →Xinhua Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 225 studies on the registry; 55 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Procedure: Translocation ILM Flap
Procedure: ILM Peeling
After vitrectomy, the ILM was dissected from the macula to the vascular arch, and the retina in the fissure area was fully released to make an MH-centered, approximately 2DD-square, ILM flap with a tip (approximately 500μm wide) above; the ILM flap was transposed approximately 25-30 degrees along the tip to the inferior temporal area with the assistance of heavy water, and a total of 1ml of perfluorodecalin fluid (heavy water) was injected to cover the MH area with the ILM flap, and the original ILM defect area corresponding to the MH was transposed to the outside of the MH. The heavy water is replaced by liquid/gas exchange. Ophthalmic 13% perfluoropropane gas (AL.CHI.MI.A. Srl) was chosen as the postoperative intraocular filling.
After vitrectomy, internal limiting membrane peeling up to the vascular arcade, thorough loosening of the macular hole area of the retina, and fluid/gas exchange. An eye-specific 13% perfluoropropane gas (AL.CHI.MI.A. Srl) was chosen for intraocular tamponade after the operation.
Best Corrected Visual Acuity
The best corrected visual acuity indicates the best visual acuity with proper refractive correction.
Time frame: 1 week, 1 month, 3 months, 1 years, 2 years after the operation
Closure rate
MH closure is mainly reflected in the outer layer of continuity closure shown on OCT.
Time frame: 1 week, 1 month, 3 months, 1 years, 2 years after the operation
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2022 (actual). Primary completion is estimated for May 2025, 34 months after the start.
Of 45 non-industry interventional studies with no phase under Retinal Perforations, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 31. This study's planned 34 months is above that.
Counting every sponsor, half of 45 studies reached it within 28 months; a quarter within 12 and three quarters within 31.
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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine →