Double Flap Technique for Macular Hole

Not Applicable

Completed

• Conditions: Macular Holes
• Interventions: Other: Surgical intervention

• Registration Number: NCT05269563
• Lead Sponsor: Omer Othman Abdullah

Brief Summary

Double flapping technique to close the macular hole.

Detailed Description

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.

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-01-28
• Study First Submitted QC: 2022-02-25
• Study First Posted: 2022-03-08
• Status Verified: 2023-03
• Primary Completion: 2023-03-23
• Study Completion: 2023-03-23
• Last Update Submitted: 2023-03-23
• Last Update Posted: 2023-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Full thickness macular hole

Exclusion Criteria

• Partial-thickness macular hole
• Vitreomacular traction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Double flap technique to secure macular hole closure.	Surgical intervention	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.

Primary Outcome Measures

Name	Time	Method
Ocular coherence tomography	The fourth week post-operatively	The closure of the hole can be assessed clearly

Trial Locations

Locations (1)

Ibinsina Modern eye and retina center; 🇮🇶 Erbil, Iraq