Single Superior ILM/ERM Flap for the FTMH.

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

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.

Study Overview

• Status: Completed
• Conditions: Ophthalmopathy
• Intervention / Treatment: Other: Surgical intervention

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 Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Erbil, Iraq, 44001
    • Omer Othman Abdullah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Full thickness macular hole

Exclusion Criteria:

• Lamellar and pseudo holes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: single superior flap technique to secure macular hole closure.; 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.	Other: Surgical intervention; Pars-plana vitrectomy.
Active Comparator: Double flap technique to secure macular hole closure.; This arm is NCT05269563, we utilize the results as a comparator to the superior single flap technique.	Other: Surgical intervention; Pars-plana vitrectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anatomical outcome	OCT	The fourth weeks post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional outcome	Best corrected visual acuity	The fourth week post-operatively.

Collaborators and Investigators

• Sponsor: Omer Othman Abdullah
• Collaborators: Ibinsina Modern Eye and Retina Center

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): March 21, 2023
• Study Completion (Actual): March 21, 2023

Study Registration Dates

• First Submitted: August 6, 2022
• First Submitted That Met QC Criteria: August 8, 2022
• First Posted (Actual): August 9, 2022

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Flap; Epiretinal membrane; Internal limiting membrane; Full thickness macular hole
• Additional Relevant MeSH Terms: Retinal Diseases; Eye Diseases; Epiretinal Membrane
• Other Study ID Numbers: IMER 99

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Both the best corrected visual acuity and the OCT.
• IPD Sharing Time Frame: Expected to be available around the end of November 2022
• IPD Sharing Access Criteria: via your permisson
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No