Single Superior ILM/ERM Flap for the FTMH.

Omer Othman Abdullah

Status: Completed

Conditions: Ophthalmopathy

Treatments: Other: Surgical intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05494242

IMER 99

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 5 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Full thickness macular hole

Exclusion criteria

• Lamellar and pseudo holes

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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5 participants in 2 patient groups

single superior flap technique to secure macular hole closure.

Experimental group

Description:

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.

Treatment:

Other: Surgical intervention

Double flap technique to secure macular hole closure.

Active Comparator group

Description:

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

Treatment:

Other: Surgical intervention