ILM Inverted Flap Size in Macular Hole

NCT04683276 | Completed

• 1 other identifier: ILM flap size
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Macular Hole

Outcome Measures

Primary Outcomes (1)

• rate of macular hole closure

  defined as the proportion of the eyes with complete MH closure based on SD-OCT findings

  6 months

Secondary Outcomes (2)

• timing of MH closure

  6 months

• BCVA

  6 months

Study Arms (4)

small flap medium-sized macular hole (SFMM)

ACTIVE COMPARATOR

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

Procedure: pars plana vitrectomy with ILM inverted flap

large flap medium-sized macular hole (LFMM)

ACTIVE COMPARATOR

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

Procedure: pars plana vitrectomy with ILM inverted flap

small flap large-sized macular hole (SFLM)

ACTIVE COMPARATOR

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

Procedure: pars plana vitrectomy with ILM inverted flap

large flap Large-sized macular hole (LFLM)

ACTIVE COMPARATOR

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

Procedure: pars plana vitrectomy with ILM inverted flap

Interventions

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.

large flap Large-sized macular hole (LFLM); large flap medium-sized macular hole (LFMM); small flap large-sized macular hole (SFLM); small flap medium-sized macular hole (SFMM)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Ophthalmic center

Al Mansurah, Dakahelia, 35516, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2020
• First Posted: December 24, 2020
• Study Start: February 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: October 1, 2020
• Last Updated: December 29, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)