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NCT Number: NCT04683276

ILM Inverted Flap Size in Macular Hole

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.

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Key information

Conditions

Idiopathic Macular Hole

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ophthalmic center

Al Mansurah, Dakahelia, 35516, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pars plana vitrectomy with ILM inverted flap

Procedure

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 24, 2020
Registry last updated
Dec 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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