Double Flap Technique for Macular Hole

Macular Holes Clinical Trial

Official title:

Double Flap Technique Utilizing ERM and ILM for Macular Hole

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05269563
• Other study ID #: IMER 11
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: March 23, 2023

Study information

• Verified date: March 2023
• Source: Ibinsina Modern Eye and Retina Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Double flapping technique to close the macular hole.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 23, 2023
• Est. primary completion date: March 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Full thickness macular hole

Exclusion Criteria:

• Partial-thickness macular hole

• Vitreomacular traction

Related Conditions & MeSH terms

• Macular Holes
• Retinal Perforations

Intervention

Other:
• Surgical intervention
Pars Plana Vitrectomy for Macular Hole Closure

Locations

Country	Name	City	State
Iraq	Ibinsina Modern eye and retina center	Erbil

Sponsors (1)

Lead Sponsor	Collaborator
Omer Othman Abdullah

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular coherence tomography	The closure of the hole can be assessed clearly	The fourth week post-operatively