PEELED INTERNAL LIMITING MEMBRANE REPOSITION

Official title

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

Overview

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.

Interventions

• 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 continuous
• 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.

Primary outcome measures

• The change in the best corrected visual acuity (BCVA) from baseline to 6 months postoperatively [Time frame: Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,]

Secondary outcome measures (7)

• The MH closure rate [Time frame: 1-month postoperatively]
• The range of inner retinal dimpling [Time frame: 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,]
• Postoperative retinal thickness [Time frame: Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,]
• The fixation stability and sensitivity threshold [Time frame: Pre-operatively, 3-month postoperatively, 6-month postoperatively,]
• mfERG P1 wave density amplitudes [Time frame: Pre-operatively, 3-month postoperatively, 6-month postoperatively,]
• M-score values [Time frame: Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,]
• NEI-VFQ-25 questionnaire scores [Time frame: Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,]

Eligibility criteria

Inclusion criteria

• The patients are diagnosed as MH with a diameter ≤ 600 µm by optical coherence tomography.
• Age ranges from 50 to 80 years.
• Do not participate in other clinical studies.
• Agree to sign an informed consent form with good compliance.

Exclusion criteria

• Traumatic macular hole.
• Combined with serious epiretinal membrane.
• Combined with diabetic retinopathy, hypertensive retinopathy.
• Combined with other ocular diseases, such as keratitis，uveitis，retinal vasculitis.
• Spherical equivalent ≥ -6.0 diopters or axial length ≥ 26 mm.
• History of intraocular surgery.
• Presence of staphyloma.
• Other ocular diseases that influence macular microstructure or visual function.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 1 center

• Xinhua Hospital Affiliated to Shanghai Jiaotong University Medicine School — Shanghai

Identifiers

NCT: NCT06359548 · XH-24-002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗