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NCT03646695 Clinical Trial

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

Macular Holes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03646695
Other study ID # ILM flap
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2018
Est. completion date May 1, 2021

Study information
Verified date August 2021
Source Vienna Institute for Research in Ocular Surgery
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date May 1, 2021
Est. primary completion date January 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - macular hole with a diameter <400µm Exclusion Criteria: - Prior ILM peeling

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• ILM flap transposition
during ILM flap Transposition, an ILM flap is placed on the macular hole
• ILM peeling
during ILM Peeling the ILM is removed around the macular hole

Locations
Country Name City State
Austria Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna

Sponsors (1)
Lead Sponsor Collaborator
Vienna Institute for Research in Ocular Surgery

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary closure of the macular hole closure of the macular hole will be assessed 3 months
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