NCT03020459

Internal Limiting Membrane Peeling-reposition to Treat Idiopathic Macular Holes

Comparing the Surgical Outcomes of Internal Limiting Membrane Peeling-reposition Versus Peeling in Idiopathic Macular Holes: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To compare the morphologic and functional outcomes of internal limiting membrane peeling-reposition versus peeling in idiopathic macular holes

Detailed description

This randomized clinical trial will be performed at a single center. Eligible patients with idiopathic macular holes will be equally randomized to internal limiting membrane (ILM) peeling-reposition group or ILM peeling group through computer-aided random allocation. A standard 3-port pars plana vitrectomy was performed by a single surgeon using the Constellation 23 gauge vitrectomy system (Alcon Laboratories Inc, Fort Worth, Texas, USA).After posterior vitreous detachment was achieved, peeling of the ILM was performed by an end gripping forceps with the assistance of Brilliant Blue G. In ILM peeling-reposition group, the peeled ILM flap is flatten back to peeled area with assistance of perfluoro-n-octane. In ILM peeling group, a round shape with 2.5 to 3.5 disc diameter of ILM is peeled. This is followed by a complete fluid-gas exchange. Patients are encouraged to maintain a face-down position for two weeks postoperatively in two groups. Postoperative measurements of BCVA and spectral domain optical coherence tomography(SD-OCT) are conducted at 1,3 and 6-month follow-up visits by independent masked observers. Macular light sensitivity and fixation stability are determined with microperimetry at 1,3, and 6 months of follow-up. Mf-ERG, M-score chart and VFQ-25 chart are performed 1,3, and 6 months of follow-up. Comparison of BCVA, anatomical closure were primarily performed between the two groups. Then, the morphologic changes of inner retina and the functional parameters measured from microperimetry, Mf-ERG, M-score chart, VFQ-25 chart were analyzed.

Conditions

• Macular Hole
• Surgery

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2017-01-01
• Primary completion: 2019-07-30
• Completion: 2019-08-01
• First posted: 2017-01-13
• Last updated: 2021-05-13

Locations

1 site across 1 country: China