Clinical Study of Translocated Internal Limiting Membrane Flap Reposition for the Treatment of Idiopathic Macular Hole

NARecruitingINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

July 1, 2022

Primary Completion Date

May 1, 2025

Study Completion Date

June 30, 2025

Conditions
Macular Holes
Interventions
PROCEDURE

Translocation ILM Flap

After vitrectomy, the ILM was dissected from the macula to the vascular arch, and the retina in the fissure area was fully released to make an MH-centered, approximately 2DD-square, ILM flap with a tip (approximately 500μm wide) above; the ILM flap was transposed approximately 25-30 degrees along the tip to the inferior temporal area with the assistance of heavy water, and a total of 1ml of perfluorodecalin fluid (heavy water) was injected to cover the MH area with the ILM flap, and the original ILM defect area corresponding to the MH was transposed to the outside of the MH. The heavy water is replaced by liquid/gas exchange. Ophthalmic 13% perfluoropropane gas (AL.CHI.MI.A. Srl) was chosen as the postoperative intraocular filling.

PROCEDURE

ILM Peeling

After vitrectomy, internal limiting membrane peeling up to the vascular arcade, thorough loosening of the macular hole area of the retina, and fluid/gas exchange. An eye-specific 13% perfluoropropane gas (AL.CHI.MI.A. Srl) was chosen for intraocular tamponade after the operation.

Trial Locations (1)

200000

RECRUITING

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai

All Listed Sponsors
collaborator

Shanghai Municipal Science and Technology Commission

OTHER_GOV

lead

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER