Internal Limiting Membrane Peeling-reposition to Treat Idiopathic Macular Holes

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

Detailed Description
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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.

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

Conditions
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Macular Hole, Surgery

Intervention / Treatment
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* Procedure: peeling-reposition
* Procedure: peeling
* Drug: Brilliant Blue G
* Other: postoperative posture
* Device: Constellation 23-gauge vitrectomy system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients are diagnosed as macular hole by optical coherence tomography. Age ranges from 50 to 80 years. The patients have indication for surgery. Exclusion Criteria: Traumatic macular hole. Combined with serious epiretinal membrane. Combined with diabetic retinopathy, hypertensive retinopathy. Combined with other ocular diseases, such as keratitis，uveitis，retinal vasculitis. - 6.0 diopters or more of spherical equivalent, 26mm or more of axial length. History of intraocular surgery. Presence of staphyloma. Other ocular diseases that could influence macular microstructure or visual function Exit criteria: For reposition group, the patients will exit the research if the peeled ILM cannot reposition successfully. Due to adverse events, especially severe adverse events, the researchers consider withdrawal of patients based on concerns of safety and ethics; Drop out; The patients voluntarily withdraw the informed consent; Serious violation of the study protocol due to the subjects or investigators' reasons; Other reasons that the researchers believe for quitting the study.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: peeling-reposition<br>After dying with Brilliant Blue G (Brilliant Blue; Gender, Germany) with the help of Constellation 23-gauge vitrectomy system (Alcon Laboratories Inc, Fort Worth, TX), the intervention of peeling-reposition was used to peel and unfold the ILM. And the postoperative posture would be prone position in two weeks for all patients after the operation. | Procedure: peeling-reposition<br>* 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.<br>Drug: Brilliant Blue G<br>* We intravitreal injected 0.1ml of Brilliant Blue G (Brilliant Blue; Gender, Germany) to dye ILM before ILM peeling.<br>* Other names: BBG;Other: postoperative posture<br>* Patients of both two groups need to keep prone position for two weeks after the operation.<br>Device: Constellation 23-gauge vitrectomy system<br>* All surgical procedures are operated on the Constellation 23-gauge vitrectomy system (Alcon Laboratories Inc, Fort Worth, TX).<br>|
| Active Comparator: peeling<br>After dying with Brilliant Blue G (Brilliant Blue; Gender, Germany) with the help of Constellation 23-gauge vitrectomy system, the intervention of peeling was used to grasped ILM with end-gripping forceps. And the postoperative posture would be prone position in two weeks for all patients after the operation. | Procedure: peeling<br>* 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.<br>Drug: Brilliant Blue G<br>* We intravitreal injected 0.1ml of Brilliant Blue G (Brilliant Blue; Gender, Germany) to dye ILM before ILM peeling.<br>* Other names: BBG;Other: postoperative posture<br>* Patients of both two groups need to keep prone position for two weeks after the operation.<br>Device: Constellation 23-gauge vitrectomy system<br>* All surgical procedures are operated on the Constellation 23-gauge vitrectomy system (Alcon Laboratories Inc, Fort Worth, TX).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity(BCVA) | Change from baseline BCVA at 6 months after operation, examined with snellen chart. | Pre-operation and 6 months after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Close rate of macular holes | Observed from optical coherence tomography | 1 month after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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macular holes