PEELED INTERNAL LIMITING MEMBRANE REPOSITION

Not Applicable

Recruiting

• Conditions: Macular Holes
• Interventions: Procedure: Peeled ILM Reposition; Procedure: ILM Peeling

• Registration Number: NCT06359548
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-03-29
• Study First Submitted QC: 2024-04-08
• Last Update Submitted: 2024-04-08
• Study First Posted: 2024-04-11
• Last Update Posted: 2024-04-11
• Study Start: 2024-04-15
• Primary Completion: 2026-06
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reposition Group	Peeled ILM Reposition	Peeled ILM Reposition
Peeling Group	ILM Peeling	ILM Peeling

Primary Outcome Measures

Name	Time	Method
The change in the best corrected visual acuity (BCVA) from baseline to 6 months postoperatively	Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,	The change of BCVA from baseline to 6-month postoperatively

Secondary Outcome Measures

Name	Time	Method
mfERG P1 wave density amplitudes	Pre-operatively, 3-month postoperatively, 6-month postoperatively,	Measured by multifocal electroretinogram (mfERG, Espion, Diagnosys LLC, Cambridge, United Kingdom)
The MH closure rate	1-month postoperatively	The MH closure rate at 1-month postoperatively
The range of inner retinal dimpling	1-month postoperatively, 3-month postoperatively, 6-month postoperatively,	The range of inner retinal dimpling was measured by OCT (RTVueXR Avanti; Optovue Inc, Fremont, CA)
NEI-VFQ-25 questionnaire scores	Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,	The scores obtain from National Eye Institute 25-Item Visual Function Questionnaire (NEI-VFQ-25 questionnaire)
The fixation stability and sensitivity threshold	Pre-operatively, 3-month postoperatively, 6-month postoperatively,	Measured by microperimetry (MAIA, CenterVue, Italy)
M-score values	Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,	Metamorphopsia score (M-score) measurement was performed using the M-chart (Inami Co, Tokyo, Japan)
Postoperative retinal thickness	Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,	With the Thickness Map protocol of the OCT, the full retinal thickness (from ILM to retinal pigment epithelium), inner retinal thickness (from ILM to inner plexiform layer (IPL)), and outer retinal thickness (from IPL to retinal pigment epithelium) of the fovea, parafovea, and perifovea were recorded, respectively.

Trial Locations

Locations (1)

Xinhua Hospital Affiliated to Shanghai Jiaotong University Medicine School; 🇨🇳 Shanghai, China