PEELED INTERNAL LIMITING MEMBRANE REPOSITION

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Macular Holes

Treatments: Procedure: ILM Peeling; Procedure: Peeled ILM Reposition

Study type: Interventional

Funder types: Other

Identifiers

NCT06359548

XH-24-002

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

Reposition Group

Experimental group

Description:

Peeled ILM Reposition

Treatment:

Procedure: Peeled ILM Reposition

Peeling Group

Active Comparator group

Description:

ILM Peeling

Treatment:

Procedure: ILM Peeling