Internal Limiting Membrane Peeling-reposition to Treat Idiopathic Macular Holes

NACompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

January 1, 2017

Primary Completion Date

July 30, 2019

Study Completion Date

August 1, 2019

Conditions
Macular HoleSurgery
Interventions
PROCEDURE

peeling-reposition

"After dying with Brilliant Blue G (BBG, Brilliant Blue; Gender, Germany), a horizontal ILM strip is peeled off in inferior quadrant of macular area. Then the ILM was peeled from inferior to superior area continuously. The ILM roll was unfolded with assistance of perfluoro-n-octane (PFO). Finally, the position of the fixed ILM flap is adjusted under PFO bubble using flute needle or forceps.This was followed by a complete fluid-gas exchange using 14% perfluoropropane gas.Patients are introduced to maintain facedown position for two weeks postoperatively."

PROCEDURE

peeling

After dying with Brilliant Blue G (Brilliant Blue; Gender, Germany), a horizontal ILM strip is peeled off in inferior quadrant of macular area. Then, the strand of ILM was peeled off radially from the foveal center to vascular arcade. In result, a round -shaped with 2.5-3.5 disc diameter ILM -peeled area was created.This was followed by a complete fluid-gas exchange using 14% perfluoropropane gas. Patients are encourage to maintain facedown position for two weeks postoperatively.

DRUG

Brilliant Blue G

We intravitreal injected 0.1ml of Brilliant Blue G (Brilliant Blue; Gender, Germany) to dye ILM before ILM peeling.

OTHER

postoperative posture

Patients of both two groups need to keep prone position for two weeks after the operation.

DEVICE

Constellation 23-gauge vitrectomy system

All surgical procedures are operated on the Constellation 23-gauge vitrectomy system (Alcon Laboratories Inc, Fort Worth, TX).

Trial Locations (1)

200000

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

All Listed Sponsors
lead

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

NCT03020459 - Internal Limiting Membrane Peeling-reposition to Treat Idiopathic Macular Holes | Biotech Hunter | Biotech Hunter