Clinical trial NCT06685328: Minimal Vitrectomy and ILM Flap with Sodium Hyaluronate Gel for MH
Official title: Clinical Study of Minimal Posterior Pole Vitrectomy and Fixing the Inverted Inner Limiting Membrane Flap with Sodium Hyaluronate Gel for Macular Hole
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Macular Hole
Macular Hole Surgery
Idiopathic Macular Hole
Macular Hole of Left Eye (Disorder)
Macular Hole of Right Eye (Disorder)
Keywords: macular hole
inner limiting membrane flap
sodium hyaluronate gel
minimal posterior pole vitrectomy
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to compare the prognostic validity of two different surgical approaches: minimal posterior pole vitrectomy combined with a sodium hyaluronate gel-covered internal limiting membrane(ILM) flap with balanced saline filling and postoperative supine position, versus conventional vitrectomy combined with ILM flap flap coverage with sterile air filling and postoperative prone position.

The main question it aims to answer is:

Whether patients with macular hole have the same or even better prognosis with minimal posterior pole vitrectomy combined with sodium hyaluronate gel covered flip ILM flap accompanied by balanced salt solution filling accompanied by postoperative supine position than with conventional macular hole surgery.

Participants will:

The control group undergoes conventional vitrectomy combined with internal limbal flap coverage accompanied by sterile air filling of the vitreous cavity and three days of postoperative surgery in strict supine position. The study group undergoes minimal posterior pole vitrectomy combined with sodium hyaluronate gel-assisted flap of the inner border membrane accompanied by 24 hours of postoperative surgical treatment in a non-strict supine position.

Participants of this study come to Sichuan Provincial People's Hospital for follow-up examinations at 1 day, 3 days, 1 week, 1 month, 3 months, and 6 months postoperatively in the 23rd clinic of the Sichuan Provincial People's Hospital for review of visual acuity, intraocular pressure, fundus photography, optical coherence tomography angiography, microfluidic field of view (at 6 months postoperatively), and slit-lamp examination.

Detailed description: Macular hole is a tissue defect that occurs from the inner limiting membrane of the retina to the photoreceptor layer in the macula, severely compromising the patient's central vision. Currently, the standard of care for macular holes is complete vitrectomy combined with stripping, plugging, or flipping of the inner limiting membrane to cover the macular hole, followed by tamponade with prolonged gas or filtered air. After surgery, patients are usually required to remain in a supine position for days to weeks, which is extremely stressful. Despite the effectiveness of current methods, there is still room for thought and improvement.

Given the potential drawbacks of the current mainstream surgery, one investigator developed a minimal posterior pole vitrectomy combined with a sodium hyaluronate gel-assisted flip inner border flap technique for macular hole repair that eliminates the need for prolonged gas or filtered air tamponade and the need for patients to remain in the face-down position for long periods postoperatively. Primary healing was achieved in all postoperative macular holes. However, existing studies have small sample sizes and irregular follow-up times.

In this project, the researchers plan to investigate the prognostic effects of this minimal posterior pole vitrectomy combined with sodium hyaluronate gel-assisted flap with non-strict supine postoperative position for 24 hours and traditional vitrectomy combined with flap covering with sterile air-filled vitreous cavity and strict prone postoperative position for three days on the prognosis of macular holes, and to investigate the therapeutic effects of different surgical methods on macular holes and provide a new idea for the surgical treatment of macular holes. To provide new ideas for the surgical treatment of macular hole.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with idiopathic macular hole and 250 μm ≤ aperture size ≤ 800 μm, with clinical diagnosis based on visual acuity testing, fundus photography, and swept optical coherence tomography/optical coherence tomography angiography (SS-OCT/OCTA)
* Age ≥18 years, gender not restricted
* 22 mm ≤ eye axis ≤ 26 mm
* Patients who can cooperate with accurate microperimetry testing
* Individuals who are able to follow up at the time specified by the researcher

Exclusion Criteria:

* Coexisting active eyelid or appendage infections
* Coexisting ocular pathology other than cataract that affects vision (e.g., retinal detachment or proliferative vitreoretinopathy; diabetic retinopathy; retinal vascular occlusion; uveitis; ocular tumors; glaucoma)
* patients who refused to be randomized
* Other relevant medical history such as cranial brain disease, systemic immune system disease, etc.
* Those who have received medical or surgical treatment other than myopia and cataract in the study eye within the previous 12 months
* Other patients who, in the opinion of the investigator, should be excluded.

Primary outcomes:
measure: postoperative best corrected visual acuity
timeFrame: 1 day, 3 days, 1 week, 1 month, 3 months, 6 months after surgery
Secondary outcomes:
measure: The time point at which best corrected visual acuity is achieved
timeFrame: 1 day, 3 days, 1 week, 1 month, 3 months, 6 months after surgery
measure: Anatomic closure rate at 6 months postoperatively
timeFrame: 1 day, 3 days, 1 week, 1 month, 3 months, 6 months after surgery
measure: Postoperative cataract progression rates in two surgical modalities
timeFrame: 1 day, 3 days, 1 week, 1 month, 3 months, 6 months after surgery
measure: Proportion of postoperative displacement of the internal limiting membrane in the two surgical modalities
timeFrame: 1 day, 3 days, 1 week, 1 month, 3 months, 6 months after surgery
measure: Microperimetry changes: microperimetry at 6 months postoperatively
timeFrame: 6 months after surgery
measure: Incidence of adverse events
timeFrame: Within 6 months after surgery
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
Study officials:
References: