Minimal Vitrectomy and ILM Flap with Sodium Hyaluronate Gel for MH

NAEnrolling by invitationINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

November 1, 2024

Primary Completion Date

June 1, 2025

Study Completion Date

June 30, 2027

Conditions
Macular HoleMacular Hole SurgeryIdiopathic Macular HoleMacular Hole of Left Eye (Disorder)Macular Hole of Right Eye (Disorder)
Interventions
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

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.

PROCEDURE

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

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.

Trial Locations (1)

610072

Sichuan Provincial People's Hospital, Chengdu

All Listed Sponsors
lead

Jie Zhong

OTHER