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NCT03465865 Clinical Trial

Visual Acuity and Optical Coherence Tomography One Year After ILM-flap Transposition

Macular Hole Clinical Trial

Official title:
Visual Acuity and Optical Coherence Tomography One Year After ILM-flap Transposition for Surgical Repair of Macular Holes

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03465865
Other study ID # ILMflap
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2017
Est. completion date December 31, 2021

Study information
Verified date January 2021
Source Vienna Institute for Research in Ocular Surgery
Contact Oliver Findl, Prof.
Phone +43 1 91021-84611
Email oliver.findl@wgkk.at
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

ILM-flap (internal limiting Membrane-flap) transposition is a new surgical option in repair of macular holes, therefore one year outcomes are needed to better evaluate that method.

Description:

Patients that have been scheduled for vitrectomy with ILM-flap transposition, a new surgical option in repair of macular holes, are invited to a follow-up one year after surgery, including optical coherence tomography and visual acuity testing.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - history of ILM-flap transposition Exclusion Criteria: - none

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• optical coherence tomography
optical coherence tomography enables diagosis of macular structures and therefore provides information on macular hole closure.

Locations
Country Name City State
Austria VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - 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 OCT macular hole closure is assessed with optical coherence tomography 5 minutes
Secondary visual acuity visual acuity describes functional outcomes of the eye 5 minutes
See also
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