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The (Flip and Fix) Internal Limiting Flap Technique Versus the Classic Temporal Flap for Macular Hole Repair

NCT06441656 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-06-04

No results posted yet for this study

Summary

Purpose To describe a novel technique of MH repair and compare it to the perfluorocarbon liquid (PFCL) assisted temporal ILM flap technique.

Methods Twenty-two eyes of 22 patients with MH were randomized on 1:1 basis into two groups. Group A cases were treated using the (Flip and Fix) technique in which the single-layer ILM flap was (flipped), flattened over the macula using PFCL and (fixed) in place using 2 drops of autologous non-heparinized blood over the superonasal and the inferonasal edges of the flap (away from the MH center). Group B patients had the classic temporal ILM flap technique without using the PFCL or autologous blood. All patients were followed up for a period of 6 months after the surgery.

Results No significant difference was observed in initial and final visual acuities between Groups A and B. Intraoperative flap displacement and did not occur in Group A and occurred in 2 eyes in Group B (18.2%) one of them showed failed MH closure and required reoperation, These 2 cases had a final (W shape) MH closure and a worse final vision than the remaining cases which had either (U shape) or (V shape) final MH closure.

Conclusions The study results show that the (Flip and Fix) technique is as effective as the PFCL-assisted temporal ILM flap technique and is associated with less ILM flap displacement risk for the repair of macular holes.

Conditions

  • Hacular Hole Repair

Interventions

PROCEDURE

Vitrectomy with ILM flap

In both groups, a single-layer ILM temporal flap of approximately 2 times the size of the optic disc was fashioned using an ILM forceps temporal to the macula. The nasal edge of the flap was not detached from the temporal MH edge. The flap was reflected nasally to cover the MH

Sponsors & Collaborators

  • Alexandria University

    lead OTHER

Principal Investigators

  • Islam SH Ahmed, M.D. · University of Alexandria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2022-02-01
Completion
2023-02-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06441656 on ClinicalTrials.gov