ILM Inverted Flap Size in Macular Hole

Mansoura University

Status: Completed

Conditions: Idiopathic Macular Hole

Treatments: Procedure: pars plana vitrectomy with ILM inverted flap

Study type: Interventional

Funder types: Other

Identifiers

NCT04683276

ILM flap size

Details and patient eligibility

About

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.

Full 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).

Enrollment: 42 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 4 patient groups

small flap medium-sized macular hole (SFMM)

Active Comparator group

Description:

small flap (1-2 disc-diameter) was performed in medium sized macular hole (250-400 um)

Treatment:

Procedure: pars plana vitrectomy with ILM inverted flap

large flap medium-sized macular hole (LFMM)

Active Comparator group

Description:

large flap (3-4 disc-diameter) was performed in medium sized macular hole (250-400 um)

Treatment:

Procedure: pars plana vitrectomy with ILM inverted flap

small flap large-sized macular hole (SFLM)

Active Comparator group

Description:

small flap (1-2 disc-diameter) was performed in Large sized macular hole (\>400 um)

Treatment:

Procedure: pars plana vitrectomy with ILM inverted flap

large flap Large-sized macular hole (LFLM)

Active Comparator group

Description:

large flap (3-4 disc-diameter) was performed in large sized macular hole (\>400 um)

Treatment:

Procedure: pars plana vitrectomy with ILM inverted flap