Double Flap Technique for Macular Hole

Omer Othman Abdullah

Status: Completed

Conditions: Macular Holes

Treatments: Other: Surgical intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05269563

IMER 11

Details and patient eligibility

About

Double flapping technique to close the macular hole.

Full 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.

Enrollment: 20 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Full thickness macular hole

Exclusion criteria

• Partial-thickness macular hole
• Vitreomacular traction

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Double flap technique to secure macular hole closure.

Experimental group

Description:

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.

Treatment:

Other: Surgical intervention