Study of Surgery in Patients With Idiopathic Macular Hole

Study Overview
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Brief Summary
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The purpose of this study is to determine the effects of two different internal limiting membrane peeling with distinct diameters after macular hole surgery on anatomical closure grades.

Detailed Description
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The purpose of this study is to investigate two distinct diameter of internal limiting membrane peeling on anatomical outcomes of macular hole surgery with different preoperative idiopathic macular hole.

Official Title
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A Randomized, Double-masked, Multicenter, Controlled Study of Effects of Internal Membrane Peeling Surgery in Patients With Idiopathic Macular Hole Measured by Optical Coherence Tomography.

Conditions
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Idiopathic Macular Hole, Surgery

Intervention / Treatment
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* Procedure: ILM peeling surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with IMH patients signed the ICF patients with course of IMH less than 3 years Exclusion Criteria: patients with hyper myopia patients with traumatic macular hole accompanied or secondary of other fundus disease open or reopen after receiving MH surgery patients with retinal detachment received vitrectomy due to other diseases glaucoma cannot be controled by medication patients with other retinal or choroidal disease that may affect VA poor patients compliance poor condition that cannot undertake the surgery dioptric media opacities which make it difficult to exam fundus or measure on OCT

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 4PD diameter of ILM peeling in surgery<br>Patients were stratified according to the macular hole closure index(MHCI) measured by OCT into 3 subgroup (MHCI<0.5, 0.5≤MHCI<0.7, MHCI≥0.7 ). And then randomized into 2 different intervention groups. If randomized into 4PD (papillary diameter) group, patients were given 4PD diameter of ILM (internal limiting membrane) peeling in surgery. | Procedure: ILM peeling surgery<br>* 4PD or 2PD diameter of ILM peeling in surgery was given to patients with IMH (idiopathic macular hole)<br>|
| Experimental: 2PD diameter of ILM peeling in surgery<br>Patients were stratified according to the macular hole closure index(MHCI) measured by OCT into 3 subgroup (MHCI<0.5, 0.5≤MHCI<0.7, MHCI≥0.7 ). And then randomized into 2 different intervention groups. If randomized into 2PD (papillary diameter) group, patients were given 2PD diameter of ILM (internal limiting membrane) peeling in surgery. | Procedure: ILM peeling surgery<br>* 4PD or 2PD diameter of ILM peeling in surgery was given to patients with IMH (idiopathic macular hole)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anatomical closure grades in OCT | The anatomical outcomes were defined as good closure and poor closure. | 6 months | 
| Change of anatomical closure grades in OCT | The anatomical outcomes were defined as good closure and poor closure. | 1 month, 3 months, 6 months, 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in BCVA (best corrected visual acuity). | BCVA were measured by ETDRS chart. | 1 month, 3 months, 6 months, 1 year |