Clinical Study of Translocated Internal Limiting Membrane Flap Reposition for the Treatment of Idiopathic Macular Hole

Not Applicable

Recruiting

• Conditions: Macular Holes
• Interventions: Procedure: Translocation ILM Flap; Procedure: ILM Peeling

• Registration Number: NCT06063005
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2023-09-25
• Study First Submitted QC: 2023-09-25
• Status Verified: 2023-10
• Study First Posted: 2023-10-02
• Last Update Submitted: 2023-10-25
• Last Update Posted: 2023-10-30
• Primary Completion: 2025-05-01
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• Participants who can understand the purpose of this clinical trial, volunteer to participate, sign an informed consent form, and can complete the postoperative follow-up on time.
• Participants diagnosed with idiopathic macular hole (IMH).
• Based on OCT scans, the minimum horizontal diameter of the macular hole is >500 and <900 µm.
• Participants with an axial length <26.0mm and a myopic degree lower than 6D.
• For participants with bilateral macular holes, the eye with a larger hole diameter will be included.

Exclusion Criteria

• Patients with the following retinal disorders: age-related macular degeneration, epi-macular membrane neovascularization, non-macular retinal tears, lesions of the retinal pigment epithelium and choroid, inherited or degenerative retinal diseases, optic neuropathies, retinal vascular diseases; patients with large macular holes accompanied by retinal detachment;
• Patients with high myopia (axial length ≥ 26.0mm and myopia exceeding 6D);
• Patients with a history of ocular trauma or retinal laser treatment;
• Patients with glaucoma, ocular infections, inflammations, tumors, corneal diseases, or amblyopia;
• Patients with contraindications to vitrectomy;
• Patients with severe or unstable systemic diseases;
• Patients with a fasting blood glucose level ≥ 9mmol/L before surgery;
• Patients who participated in other clinical trials involving drugs or medical devices within 30 days prior to screening;
• Patients with a history of intraocular surgery within 3 months prior to screening;
• Patients with reduced visual function or vision in the contralateral eye as determined by the investigator;
• Patients who are not considered suitable for enrollment by the investigator for other reasons.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Translocation	Translocation ILM Flap	-
Peeling	ILM Peeling	-

Primary Outcome Measures

Name	Time	Method
Best Corrected Visual Acuity	1 week, 1 month, 3 months, 1 years, 2 years after the operation	The best corrected visual acuity indicates the best visual acuity with proper refractive correction.

Secondary Outcome Measures

Name	Time	Method
Closure rate	1 week, 1 month, 3 months, 1 years, 2 years after the operation	MH closure is mainly reflected in the outer layer of continuity closure shown on OCT.

Trial Locations

Locations (1)

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China