Single Superior ILM/ERM Flap for the FTMH.

Not Applicable

Completed

• Conditions: Ophthalmopathy
• Interventions: Other: Surgical intervention

• Registration Number: NCT05494242
• Lead Sponsor: Omer Othman Abdullah

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-08-06
• Study First Submitted QC: 2022-08-08
• Study First Posted: 2022-08-09
• Study Start: 2022-09-01
• Status Verified: 2023-03
• Primary Completion: 2023-03-21
• Study Completion: 2023-03-21
• Last Update Submitted: 2023-03-23
• Last Update Posted: 2023-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Full thickness macular hole

Exclusion Criteria

• Lamellar and pseudo holes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Double flap technique to secure macular hole closure.	Surgical intervention	This arm is NCT05269563, we utilize the results as a comparator to the superior single flap technique.
single superior flap technique to secure macular hole closure.	Surgical intervention	The patients are divided into two groups: For the first group, the flap will be carried out under the effect of perfluorocarbon. For the second group, the flap stabilized with methylcellulose.

Primary Outcome Measures

Name	Time	Method
Anatomical outcome	The fourth weeks post-operatively	OCT

Secondary Outcome Measures

Name	Time	Method
Functional outcome	The fourth week post-operatively.	Best corrected visual acuity

Trial Locations

Locations (1)

Omer Othman Abdullah; 🇮🇶 Erbil, Iraq