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ILM Inverted Flap Size in Macular Hole

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ClinicalTrials.gov Identifier: NCT04683276
Recruitment Status : Completed
First Posted : December 24, 2020
Last Update Posted : December 29, 2020
Sponsor:
Information provided by (Responsible Party):
Mansoura University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Idiopathic Macular Hole Procedure: pars plana vitrectomy with ILM inverted flap Not Applicable

Detailed Description:
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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of the Inverted Internal Limiting Membrane Flap Diameter on Idiopathic Macular Hole Closure: Comparative Randomized Study
Actual Study Start Date : February 1, 2019
Actual Primary Completion Date : April 1, 2020
Actual Study Completion Date : October 1, 2020
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: small flap medium-sized macular hole (SFMM)
small flap (1-2 disc-diameter) was performed in medium sized macular hole (250-400 um)
 Procedure: pars plana vitrectomy with ILM inverted flap
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.
Active Comparator: large flap medium-sized macular hole (LFMM)
large flap (3-4 disc-diameter) was performed in medium sized macular hole (250-400 um)
 Procedure: pars plana vitrectomy with ILM inverted flap
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.
Active Comparator: small flap large-sized macular hole (SFLM)
small flap (1-2 disc-diameter) was performed in Large sized macular hole (>400 um)
 Procedure: pars plana vitrectomy with ILM inverted flap
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.
Active Comparator: large flap Large-sized macular hole (LFLM)
large flap (3-4 disc-diameter) was performed in large sized macular hole (>400 um)
 Procedure: pars plana vitrectomy with ILM inverted flap
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.


Outcome Measures
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Primary Outcome Measures :
  1. rate of macular hole closure [ Time Frame: 6 months ]
    defined as the proportion of the eyes with complete MH closure based on SD-OCT findings


Secondary Outcome Measures :
  1. timing of MH closure [ Time Frame: 6 months ]
    the time of complete macular hole closure

  2. BCVA [ Time Frame: 6 months ]
    best corrected visual acuity


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04683276


Locations
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Egypt
Ophthalmic center
Mansoura, Dakahelia, Egypt, 35516
Sponsors and Collaborators
Mansoura University
More Information
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Responsible Party: Mansoura University
ClinicalTrials.gov Identifier: NCT04683276    
Other Study ID Numbers: ILM flap size
First Posted: December 24, 2020    Key Record Dates
Last Update Posted: December 29, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Retinal Perforations
Retinal Diseases
Eye Diseases