Double Flap Technique for Macular Hole

Double Flap Technique Utilizing ERM and ILM for Macular Hole

Double flapping technique to close the macular hole.

Study Overview

• Status: Completed
• Conditions: Macular Holes
• Intervention / Treatment: Other: Surgical intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bestun Saleh, PhD; Phone Number: +9647507110110; Email: bestun@hotmail.fr
• Study Contact Backup: Name: Goran Abdullah, Doctorate; Phone Number: +9647504803950; Email: goranshad@gmail.com

Study Locations

• Iraq
  • Erbil, Iraq, 44001
    • Ibinsina Modern Eye and Retina Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Full thickness macular hole

Exclusion Criteria:

• Partial-thickness macular hole
• Vitreomacular traction

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Double flap technique to secure macular hole closure.; 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.	Other: Surgical intervention; Pars Plana Vitrectomy for Macular Hole Closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular coherence tomography	The closure of the hole can be assessed clearly	The fourth week post-operatively

Collaborators and Investigators

• Sponsor: Omer Othman Abdullah

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): March 23, 2023
• Study Completion (Actual): March 23, 2023

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: February 25, 2022
• First Posted (Actual): March 8, 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: Double Flaps
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Perforations
• Other Study ID Numbers: IMER 11

Drug and device information, study documents

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