Single Superior ILM/ERM Flap for the FTMH.

NCT ID: NCT05494242

Last Updated: 2023-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-03-21

Brief Summary

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In this study, the investigators will make the only upper flap either from the internal limiting membrane or from the epiretinal membrane to cover the full thickness macular hole.

Detailed Description

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After the investigators completed the clinical trial NCT05269563, which was a double flap technique; that consists of two flaps from the internal limiting membrane and the epiretinal membrane. The inferior flap was implanted inside the hole, but the upper flap was utilized to cover the hole. The results were encouraging. Therefore, in this study, the investigators will make the only upper flap to cover the full thickness macular hole, to compare both visual and anatomical outcomes with the double flapped technique (NCT05269563) results. Therefore the double flap will be our control.

Conditions

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Ophthalmopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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single superior flap technique to secure macular hole closure.

The patients are divided into two groups:

For the first group, the flap will be carried out under the effect of perfluorocarbon.

For the second group, the flap stabilized with methylcellulose.

Group Type EXPERIMENTAL

Surgical intervention

Intervention Type OTHER

Pars-plana vitrectomy.

Double flap technique to secure macular hole closure.

This arm is NCT05269563, we utilize the results as a comparator to the superior single flap technique.

Group Type ACTIVE_COMPARATOR

Surgical intervention

Intervention Type OTHER

Pars-plana vitrectomy.

Interventions

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Surgical intervention

Pars-plana vitrectomy.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Full thickness macular hole

Exclusion Criteria

* Lamellar and pseudo holes
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ibinsina Modern Eye and Retina Center

OTHER

Sponsor Role collaborator

Omer Othman Abdullah

OTHER

Sponsor Role lead

Responsible Party

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Omer Othman Abdullah

Associate consultant ophthalmologist

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Omer Othman Abdullah

Erbil, , Iraq

Site Status

Countries

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Iraq

Other Identifiers

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IMER 99

Identifier Type: -

Identifier Source: org_study_id

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