Double Flap Technique for Macular Hole

NCT ID: NCT05269563

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-03-23

Brief Summary

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Double flapping technique to close the macular hole.

Detailed Description

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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.

Conditions

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Macular Holes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Double flap technique to secure macular hole closure.

Single ILM flap technique is already performing worldwide; however, sometimes it is associated with flap displacement. To overcome this issue, the double flap technique was tried.

Group Type EXPERIMENTAL

Surgical intervention

Intervention Type OTHER

Pars Plana Vitrectomy for Macular Hole Closure

Interventions

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Surgical intervention

Pars Plana Vitrectomy for Macular Hole Closure

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Full thickness macular hole

Exclusion Criteria

* Partial-thickness macular hole
* Vitreomacular traction
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Omer Othman Abdullah

OTHER

Sponsor Role lead

Responsible Party

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Omer Othman Abdullah

Associate consultant ophthalmologist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Omer Abdullah, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Ibinsina Modern Eye and Retina Center

Locations

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Ibinsina Modern eye and retina center

Erbil, , Iraq

Site Status

Countries

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Iraq

Other Identifiers

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IMER 11

Identifier Type: -

Identifier Source: org_study_id

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