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PEELED INTERNAL LIMITING MEMBRANE REPOSITION

RecruitingNAAges 50 Years - 90 YearsAllXinhua Hospital, Shanghai Jiao Tong University Sc…
NCT06359548 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Macular hiatus (MH) refers to a tissue defect in the photoreceptor cell layer of the inner boundary membrane of the optic disc in the macular region. Among them, idiopathic macular hiatus (IMH) is more common in people over 60 years old and is a common eye disease. With the aging of society, the number of patients increases, and it severely damages the patients' vision and life quality. Previously, the conventional surgical approach for treating MH was vitrectomy combined with inner limiting membrane (ILM) peeling. Although the closure rate of MH is high, many damages to the morphology and function of the ILM peeled area have been found. Our team firstly report a novel technique of peeled ILM reposition. Compared to traditional ILM peeling, the novel technique peeled ILM reposition maintains the integrity of internal retina by "pull" back the ILM flap. The previous pilot clinical study s

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. The patients are diagnosed as MH with a diameter ≤ 600 µm by optical coherence tomography. 2. Age ranges from 50 to 80 years. 3. Do not participate in other clinical studies. 4. Agree to sign an informed consent form with good compliance. Exclusion Criteria: 1. Traumatic macular hole. 2. Combined with serious epiretinal membrane. 3. Combined with diabetic retinopathy, hypertensive retinopathy. 4. Combined with other ocular diseases, such as keratitis，uveitis，retinal vasculitis. 5. Spherical equivalent ≥ -6.0 diopters or axial length ≥ 26 mm. 6. History of intraocular surgery. 7. Presence of staphyloma. 8. Other ocular diseases that influence macular microstructure or visual function.
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What it tests

  • Peeled ILM Reposition
  • ILM Peeling
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Where

1 site
Xinhua Hospital Affiliated to Shanghai Jiaotong University Medicine School
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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