PEELED INTERNAL LIMITING MEMBRANE REPOSITION

PEELED INTERNAL LIMITING MEMBRANE REPOSITION FOR IDIOPATHIC MACULAR HOLES: A Single-centre, Randomized, Prospective Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Macular Holes
• Intervention / Treatment: Procedure: Peeled ILM Reposition; Procedure: ILM Peeling

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tian Tian, MD，PhD; Phone Number: +8615216695095; Email: tiantianoph@163.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Xinhua Hospital Affiliated to Shanghai Jiaotong University Medicine School
    • Contact: Tian Tian, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reposition Group; Peeled ILM Reposition	Procedure: Peeled ILM Reposition; The ILM was stained using 0.1 mL of indocyanine green（ICG) for approximately 1minute after PPV. The ILM was grasped with end gripping forceps (Grieshaber Maxgrip 723.13; Alcon Laboratories Inc) at a point away from the center of MH around one disc diameter in inferior quadrant of macular area. First, a horizontal ILM strip was peeled off with a width approximately 1.5 to 2.5 disc diameter. Then, the edge of the horizontal ILM strip was grasped and peeled from inferior to superior area continuously.Then the "ILM roll" was flattened back to peeled area assisted with approximately 1.0 mL of PFO (Perfluoron, Alcon Laboratories, Inc). The position of the fixed ILM flap was adjusted under PFO bubble using flute needle or forceps if required.; Other Names: ILM Flap reposition; ILM Flap covering
Active Comparator: Peeling Group; ILM Peeling	Procedure: ILM Peeling; The ILM was stained using 0.1 mL of indocyanine green（ICG) for approximately 1minute after PPV. The ILM was grasped with end gripping forceps (Grieshaber Maxgrip 723.13; Alcon Laboratories Inc). The strand of ILM was peeled off radially from the foveal center to the vascular arcade. As a result, a round-shaped, 2.5-disk diameter to 3.5-disk diameter ILM-peeled area was created.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The MH closure rate	The MH closure rate at 1-month postoperatively	1-month postoperatively
The range of inner retinal dimpling	The range of inner retinal dimpling was measured by OCT (RTVueXR Avanti; Optovue Inc, Fremont, CA)	1-month postoperatively, 3-month postoperatively, 6-month postoperatively,
Postoperative retinal thickness	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.	Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,
The fixation stability and sensitivity threshold	Measured by microperimetry (MAIA, CenterVue, Italy)	Pre-operatively, 3-month postoperatively, 6-month postoperatively,
mfERG P1 wave density amplitudes	Measured by multifocal electroretinogram (mfERG, Espion, Diagnosys LLC, Cambridge, United Kingdom)	Pre-operatively, 3-month postoperatively, 6-month postoperatively,
M-score values	Metamorphopsia score (M-score) measurement was performed using the M-chart (Inami Co, Tokyo, Japan)	Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,
NEI-VFQ-25 questionnaire scores	The scores obtain from National Eye Institute 25-Item Visual Function Questionnaire (NEI-VFQ-25 questionnaire)	Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Tian Tian, MD，PhD, Xinhua Hospital, Shanghai Jiaotong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: March 29, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Perforations
• Other Study ID Numbers: XH-24-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No