ILM Inverted Flap Size in Macular Hole

Idiopathic Macular Hole Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04683276
• Other study ID #: ILM flap size
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: December 2020
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Idiopathic Macular Hole
• Retinal Perforations

Intervention

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.

Locations

Country	Name	City	State
Egypt	Ophthalmic center	Mansoura	Dakahelia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of macular hole closure	defined as the proportion of the eyes with complete MH closure based on SD-OCT findings	6 months
Secondary	timing of MH closure	the time of complete macular hole closure	6 months
Secondary	BCVA	best corrected visual acuity	6 months