PEELED INTERNAL LIMITING MEMBRANE REPOSITION

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 suggests that the novel technique peeled ILM reposition surgical intervention can achieve better morphology and functional prognosis. However, there is currently a lack of larger sample size prospective randomized controlled studies to further clarify the clinical efficacy of this new surgical technique in treating IMH. This study aims to conduct a single center, prospective, and randomized controlled study, combined with previous work, to analyze the efficacy of this novel technique peeled ILM peeling in the treatment of IMH. We hypothesize that this novel technique can achieved better morphological and functional prognosis compared to traditional ILM peeling.

NCT Number	NCT06359548
Lead Sponsor	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Conditions	Macular Holes
Enrollment	90 participants
Start Date	2024-04-15
Primary Completion	2026-06 (estimated)
Study Completion	2026-11 (estimated)
Updated on ClinicalTrials.gov	2024-04-11