Single Superior ILM/ERM Flap for the FTMH.

Ophthalmopathy Clinical Trial

Official title:

Single Superior Internal Limiting Membrane/Epiretinal Membrane Flap for the Full Thickness Macular Hole

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05494242
• Other study ID #: IMER 99
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: March 21, 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

In this study, the investigators will make the only upper flap either from the internal limiting membrane or from the epiretinal membrane to cover the full thickness macular hole.

Description:

After the investigators completed the clinical trial NCT05269563, which was a double flap technique; that consists of two flaps from the internal limiting membrane and the epiretinal membrane. The inferior flap was implanted inside the hole, but the upper flap was utilized to cover the hole. The results were encouraging. Therefore, in this study, the investigators will make the only upper flap to cover the full thickness macular hole, to compare both visual and anatomical outcomes with the double flapped technique (NCT05269563) results. Therefore the double flap will be our control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: March 21, 2023
• Est. primary completion date: March 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Full thickness macular hole

Exclusion Criteria:

• Lamellar and pseudo holes

Related Conditions & MeSH terms

• Epiretinal Membrane
• Eye Diseases
• Ophthalmopathy

Intervention

Other:
• Surgical intervention
Pars-plana vitrectomy.

Locations

Country	Name	City	State
Iraq	Omer Othman Abdullah	Erbil

Sponsors (2)

Lead Sponsor	Collaborator
Omer Othman Abdullah	Ibinsina Modern Eye and Retina Center

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anatomical outcome	OCT	The fourth weeks post-operatively
Secondary	Functional outcome	Best corrected visual acuity	The fourth week post-operatively.