ILM Inverted Flap Size in Macular Hole

Study Overview
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Brief Summary
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In the current study, the investigators described the results of a randomized, comparative clinical trial that was conducted to study the impact of the size of internal limiting membrane (ILM) inverted flap on rate and timing of idiopathic macular hole closure.

Detailed Description
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A prospective randomized comparative study included patients with idiopathic macular hole (MH) attending outpatient clinic.Eligible eyes were divided into 2 groups based on the narrowest diameter of the MH measured by spectral domain optical coherence tomography (SD-OCT). MHs from 250 to 400µm were classified as Medium-sized MHs and MHs > 400 µm were classified as Large-sized MHs. Within each group, eyes were randomly assigned to either small-flap (1-2DD) or large flap (from >2 to 4DD).

Official Title
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Impact of the Inverted Internal Limiting Membrane Flap Diameter on Idiopathic Macular Hole Closure: Comparative Randomized Study

Conditions
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Idiopathic Macular Hole

Intervention / Treatment
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* Procedure: pars plana vitrectomy with ILM inverted flap


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eyes with stage 4 idiopathic MHs with a diameter >250µm on spectral domain optical coherence tomography (SD-OCT) Exclusion Criteria: traumatic MH myopic MHs, MH secondary to retinal detachment, long-standing MH> 12 months previous retinal surgeries high myopia with an axial length > 26.0 mm other ocular pathologies interfering with the interpretation of the OCT reports.
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: small flap medium-sized macular hole (SFMM)<br>small flap (1-2 disc-diameter) was performed in medium sized macular hole (250-400 um) | Procedure: pars plana vitrectomy with ILM inverted flap<br>* Complete vitrectomy was done with the aid of triamcinolone acetonide followed by fluid-air exchange. Staining of the ILM was carried with 0.05% solution of Brilliant Blue dye (BBG), (Ocublue plus, Aurolab, India) for 30 seconds, ILM peeling was proceeded leaving a circle of ILM measuring approximately 1-2 DD in SF groups and >2 to 4DD in LF group, centered around the MH. The ILM outside the parafoveal area was peeled to the arcade. The ILM around the hole was then detached from the retina up to the edge of the hole. The ILM flap around the edge of the hole was inverted over the MH using a scraper.<br>|
| Active Comparator: large flap medium-sized macular hole (LFMM)<br>large flap (3-4 disc-diameter) was performed in medium sized macular hole (250-400 um) | Procedure: pars plana vitrectomy with ILM inverted flap<br>* Complete vitrectomy was done with the aid of triamcinolone acetonide followed by fluid-air exchange. Staining of the ILM was carried with 0.05% solution of Brilliant Blue dye (BBG), (Ocublue plus, Aurolab, India) for 30 seconds, ILM peeling was proceeded leaving a circle of ILM measuring approximately 1-2 DD in SF groups and >2 to 4DD in LF group, centered around the MH. The ILM outside the parafoveal area was peeled to the arcade. The ILM around the hole was then detached from the retina up to the edge of the hole. The ILM flap around the edge of the hole was inverted over the MH using a scraper.<br>|
| Active Comparator: small flap large-sized macular hole (SFLM)<br>small flap (1-2 disc-diameter) was performed in Large sized macular hole (>400 um) | Procedure: pars plana vitrectomy with ILM inverted flap<br>* Complete vitrectomy was done with the aid of triamcinolone acetonide followed by fluid-air exchange. Staining of the ILM was carried with 0.05% solution of Brilliant Blue dye (BBG), (Ocublue plus, Aurolab, India) for 30 seconds, ILM peeling was proceeded leaving a circle of ILM measuring approximately 1-2 DD in SF groups and >2 to 4DD in LF group, centered around the MH. The ILM outside the parafoveal area was peeled to the arcade. The ILM around the hole was then detached from the retina up to the edge of the hole. The ILM flap around the edge of the hole was inverted over the MH using a scraper.<br>|
| Active Comparator: large flap Large-sized macular hole (LFLM)<br>large flap (3-4 disc-diameter) was performed in large sized macular hole (>400 um) | Procedure: pars plana vitrectomy with ILM inverted flap<br>* Complete vitrectomy was done with the aid of triamcinolone acetonide followed by fluid-air exchange. Staining of the ILM was carried with 0.05% solution of Brilliant Blue dye (BBG), (Ocublue plus, Aurolab, India) for 30 seconds, ILM peeling was proceeded leaving a circle of ILM measuring approximately 1-2 DD in SF groups and >2 to 4DD in LF group, centered around the MH. The ILM outside the parafoveal area was peeled to the arcade. The ILM around the hole was then detached from the retina up to the edge of the hole. The ILM flap around the edge of the hole was inverted over the MH using a scraper.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of macular hole closure | defined as the proportion of the eyes with complete MH closure based on SD-OCT findings | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| timing of MH closure | the time of complete macular hole closure | 6 months | 
| BCVA | best corrected visual acuity | 6 months |