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OpenTrials
Completed

NCT Number: NCT05269563

Double Flap Technique for Macular Hole

Double flapping technique to close the macular hole.

Completed

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ibinsina Modern eye and retina center

Erbil, 44001, Iraq

About this study

Recently, it is agreed to close the macular hole with the retinal innermost layer; which is called internal limiting membrane (ILM), in most cases, the hole closes. But, sometimes the ILM single flap might displace resulting in a persistent hole.

Therefore, the investigators tried to make two flaps utilizing ILM, and sometimes certain patients have a very thin membrane over the retina; it is called epiretinal membrane (ERM). The investigators use the double flapping technique by utilizing ERM; therefore, the ILM remains and can be used if the hole resists closing with the first surgical interventions.

Here, the investigators did not use any new materials with unknown side effects on the human retina. Although the flap technique is well known; however, investigators are making a double flap to decrease the chance of persisting macular holes.

The visual recovery will be appeared in the post-operative period, whether it is the same, better, or worse.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Full thickness macular hole

Exclusion criteria

  • Partial-thickness macular hole
  • Vitreomacular traction

Treatment and study plan

Surgical intervention

Other

Pars Plana Vitrectomy for Macular Hole Closure

Primary outcomes

  1. Ocular coherence tomography

    Time frame: The fourth week post-operatively

    The closure of the hole can be assessed clearly

Sponsors and collaborators

Lead sponsor

Omer Othman Abdullah

Other

Registry information

Official study title

Double Flap Technique Utilizing ERM and ILM for Macular Hole

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 8, 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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