Minimal Vitrectomy and ILM Flap with Sodium Hyaluronate Gel for MH

NCT06685328 | Enrolling By Invitation

• 1 other identifier: 2024-598
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• postoperative best corrected visual acuity

  Testing patients' visual function through the visual acuity chart

  1 day, 3 days, 1 week, 1 month, 3 months, 6 months after surgery

Secondary Outcomes (6)

• The time point at which best corrected visual acuity is achieved

  1 day, 3 days, 1 week, 1 month, 3 months, 6 months after surgery

• Anatomic closure rate at 6 months postoperatively

  1 day, 3 days, 1 week, 1 month, 3 months, 6 months after surgery

• Postoperative cataract progression rates in two surgical modalities

  1 day, 3 days, 1 week, 1 month, 3 months, 6 months after surgery

• Proportion of postoperative displacement of the internal limiting membrane in the two surgical modalities

  1 day, 3 days, 1 week, 1 month, 3 months, 6 months after surgery

• Microperimetry changes: microperimetry at 6 months postoperatively

  6 months after surgery

Study Arms (2)

minimal posterior pole vitrectomy

EXPERIMENTAL

Patients undergo minimal posterior pole vitrectomy with tearing of the internal limiting membrane and its folding to cover the macular hole, injection of perfluorocarbon liquid to isolate the balanced salt solution, injection of sodium hyaluronate gel under the perfluorocarbon liquid to cover the folded internal limiting membrane, replacement of the perfluorocarbon liquid and filling of the vitreous cavity with the balanced salt solution and postoperative supine position for 24 hours.

Procedure: minimal posterior pole vitrectomy combined with a sodium hyaluronate gel-covered internal limiting membrane(ILM) flap with balanced saline filling and postoperative supine position

conventional vitrectomy

OTHER

Patient undergo conventional vitrectomy with tearing of the inner limiting membrane and flipping to cover the macular hole, gas-liquid exchange and sterile air to fill the vitreous cavity, keeping standard prone position for three days postoperatively.

Procedure: Conventional vitrectomy combined with inner limiting membrane flap flip coverage with sterile air filling and postoperative prone position

Interventions

minimal posterior pole vitrectomy combined with a sodium hyaluronate gel-covered internal limiting membrane(ILM) flap with balanced saline filling and postoperative supine position PROCEDURE

Vitrectomy of the posterior pole within the vascular arch was performed by a standard 25G ciliary flattening three-way tract procedure, followed by injection of a small amount of tretinoin suspension (TA) to mark the posterior vitreous cortex, which was excised. The inner limiting membrane (ILM) of the macular surface was stained with indocyanine green (ICG, 2.5 mg/ml), and the ILM around the hole was peeled off, leaving a semicircular piece of ILM attached to the hole, and then the single ILM flap was folded and covered with MH. 0.2 to 0.3 mL of hyaluronic acid gel (Bausch \& Lomb, Iviz) was injected over the inverted ILM flap using perfluorocarbon liquid for complete coverage. The perfluorocarbon liquid was aspirated. Postoperatively, the patient was advised to remain in a non-emergent supine position for 24 hours.

minimal posterior pole vitrectomy

Conventional vitrectomy combined with inner limiting membrane flap flip coverage with sterile air filling and postoperative prone position PROCEDURE

A standard 25G ciliary flattening three-way tract procedure was taken to perform posterior and midperipheral vitrectomy, followed by injection of a small amount of tretinoin (TA) to label the posterior vitreous cortex and excision of the posterior vitreous cortex within the vascular arch. The ILM on the macular surface was stained with indocyanine green (ICG, 2.5 mg/ml), and the peripapillary ILM was peeled off with forceps, leaving a semicircular piece of ILM attached to the foramen ovale, and the individual ILM flaps were then turned over and covered with MH. Air-liquid exchange was then performed and subsequent surgery was routinely performed according to existing surgical concepts. Ultrasonic emulsification and IOL implantation were selectively performed depending on the extent of the cataract and the patient's surgical needs. Antibiotic ointment is applied at the end of the procedure. After surgery, patients were advised to remain in strict prone position for 3 days.

conventional vitrectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jie Zhong: lead

Study Sites (1)

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

Location

MeSH Terms

Conditions

Retinal Perforations

Interventions

Surgical Flaps

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Surgically-Created Structures; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 12, 2024
• Study Start: November 1, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 30, 2027
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)