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OpenTrials
Completed

NCT Number: NCT05494242

Single Superior ILM/ERM Flap for the FTMH.

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.

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Key information

Conditions

Ophthalmopathy Epiretinal Membrane Eye Diseases Retinal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Omer Othman Abdullah

Erbil, 44001, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Full thickness macular hole

Exclusion criteria

  • Lamellar and pseudo holes

Treatment and study plan

Surgical intervention

Other

Pars-plana vitrectomy.

Primary outcomes

  1. Anatomical outcome

    Time frame: The fourth weeks post-operatively

    OCT

Secondary outcomes

  1. Functional outcome

    Time frame: The fourth week post-operatively.

    Best corrected visual acuity

Sponsors and collaborators

Lead sponsor

Omer Othman Abdullah

Other

Collaborators

  • Ibinsina Modern Eye and Retina Center

Registry information

Official study title

Single Superior Internal Limiting Membrane/Epiretinal Membrane Flap for the Full Thickness Macular Hole

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 9, 2022
Registry last updated
Mar 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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