ILM Flap Transposition Versus ILM Peeling for Macular Holes: a Pilot Study

Not Applicable

Completed

• Conditions: Macular Holes
• Interventions: Procedure: ILM flap transposition; Procedure: ILM peeling

• Registration Number: NCT03646695
• Lead Sponsor: Vienna Institute for Research in Ocular Surgery

Brief Summary

Patients with macular hole \<400µm will be randomized for ILM flap Transposition and ILM Peeling for surgical repair of macular holes

Detailed Description

Patients with macular hole with a diameter larger than 400µm have better sucess with ILM flap transposition, but there are no data published examining the outcome of macular hole with a diameter \<400µm. Therefore, patients with macular hole with a diameter \<400µm will be randomized for ILM flap transposition and ILM peeling for surgical repair of macular holes

Study Timeline

• Study First Submitted: 2018-08-23
• Study First Submitted QC: 2018-08-23
• Study First Posted: 2018-08-24
• Study Start: 2018-09-01
• Primary Completion: 2021-01-01
• Study Completion: 2021-05-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-21
• Last Update Posted: 2021-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• macular hole with a diameter <400µm

Exclusion Criteria

• Prior ILM peeling

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ILM flap	ILM flap transposition	vitrectomy with ILM flap transposition and gas-tamponade will be performed
ILM peeling	ILM peeling	vitrectomy with ILM peeling and gas-tamponade will be performed

Primary Outcome Measures

Name	Time	Method
closure of the macular hole	3 months	closure of the macular hole will be assessed

Trial Locations

Locations (1)

Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital; 🇦🇹 Vienna, Austria