protocolSection identificationModule nctId: NCT06359548, orgStudyIdInfo id: XH-24-002, briefTitle: PEELED INTERNAL LIMITING MEMBRANE REPOSITION, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-11, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Macular Holes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Peeled ILM Reposition, interventions name: ILM Peeling, outcomesModule primaryOutcomes measure: The change in the best corrected visual acuity (BCVA) from baseline to 6 months postoperatively, secondaryOutcomes measure: The MH closure rate, secondaryOutcomes measure: The range of inner retinal dimpling, secondaryOutcomes measure: Postoperative retinal thickness, secondaryOutcomes measure: The fixation stability and sensitivity threshold, secondaryOutcomes measure: mfERG P1 wave density amplitudes, secondaryOutcomes measure: M-score values, secondaryOutcomes measure: NEI-VFQ-25 questionnaire scores, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xinhua Hospital Affiliated to Shanghai Jiaotong University Medicine School, status: RECRUITING, city: Shanghai, country: China, contacts name: Tian Tian, Dr., role: CONTACT, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False