Clinical Trial: Internal Limiting Membrane Peeling-reposition to Treat Idiopathic Macular Holes
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Comparing the Surgical Outcomes of Internal Limiting Membrane Peeling-reposition Versus Peeling in Idiopathic Macular Holes: A Randomized Controlled Trial
Brief Summary: To compare the morphologic and functional outcomes of internal limiting membrane peeling-reposition versus peeling in idiopathic macular holes
Detailed Summary:
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 computerized block-randomization.
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 instructed to posture sitting position for 4 hours then maintain facedown position for 7 days postoperatively in ILM peeling-reposition group. Patients are encouraged to maintain a face-down position for 7 days postoperatively in ILM peeling group.
Postoperative measurements of BCVA and 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.
Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Current Primary Outcome: Best corrected visual acuity [ Time Frame: Pre-oparation,1，3，6 months after operation ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Close rate of macular holes [ Time Frame: 1month after operation ]
Original Secondary Outcome: Same as current
Information By: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Dates:
Date Received: January 11, 2017
Date Started: January 2017
Date Completion: June 2018
Last Updated: January 11, 2017
Last Verified: December 2016
