Clinical trial NCT06359548: PEELED INTERNAL LIMITING MEMBRANE REPOSITION
Official title: PEELED INTERNAL LIMITING MEMBRANE REPOSITION FOR IDIOPATHIC MACULAR HOLES: A Single-centre, Randomized, Prospective Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Macular Holes
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The change in the best corrected visual acuity (BCVA) from baseline to 6 months postoperatively
timeFrame: Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,
Secondary outcomes:
measure: The MH closure rate
timeFrame: 1-month postoperatively
measure: The range of inner retinal dimpling
timeFrame: 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,
measure: Postoperative retinal thickness
timeFrame: Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,
measure: The fixation stability and sensitivity threshold
timeFrame: Pre-operatively, 3-month postoperatively, 6-month postoperatively,
measure: mfERG P1 wave density amplitudes
timeFrame: Pre-operatively, 3-month postoperatively, 6-month postoperatively,
measure: M-score values
timeFrame: Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,
measure: NEI-VFQ-25 questionnaire scores
timeFrame: Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiaotong University Medicine School
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiaotong University School of Medicine
name: Tian Tian, MD，PhD
role: PRINCIPAL_INVESTIGATOR
References: