ILM Inverted Flap Size in Macular Hole

Not Applicable

Completed

• Conditions: Idiopathic Macular Hole
• Interventions: Procedure: pars plana vitrectomy with ILM inverted flap

• Registration Number: NCT04683276
• Lead Sponsor: Mansoura University

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.

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).

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2019-02-01
• Primary Completion: 2020-04-01
• Study Completion: 2020-10-01
• Status Verified: 2020-12
• Study First Submitted: 2020-12-19
• Study First Submitted QC: 2020-12-19
• Study First Posted: 2020-12-24
• Last Update Submitted: 2020-12-24
• Last Update Posted: 2020-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Eyes with stage 4 idiopathic MHs with a diameter >250µm on spectral domain optical coherence tomography (SD-OCT)

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
large flap medium-sized macular hole (LFMM)	pars plana vitrectomy with ILM inverted flap	large flap (3-4 disc-diameter) was performed in medium sized macular hole (250-400 um)
small flap medium-sized macular hole (SFMM)	pars plana vitrectomy with ILM inverted flap	small flap (1-2 disc-diameter) was performed in medium sized macular hole (250-400 um)
large flap Large-sized macular hole (LFLM)	pars plana vitrectomy with ILM inverted flap	large flap (3-4 disc-diameter) was performed in large sized macular hole (\>400 um)
small flap large-sized macular hole (SFLM)	pars plana vitrectomy with ILM inverted flap	small flap (1-2 disc-diameter) was performed in Large sized macular hole (\>400 um)

Primary Outcome Measures

Name	Time	Method
rate of macular hole closure	6 months	defined as the proportion of the eyes with complete MH closure based on SD-OCT findings

Secondary Outcome Measures

Name	Time	Method
BCVA	6 months	best corrected visual acuity
timing of MH closure	6 months	the time of complete macular hole closure

Trial Locations

Locations (1)

Ophthalmic center; 🇪🇬 Mansoura, Dakahelia, Egypt