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

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ClinicalTrials.gov Identifier: NCT03646695
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Prim. Prof. Dr. Oliver Findl, MBA, 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

Condition or disease Intervention/treatment Phase
Macular Holes Procedure: ILM flap transposition Procedure: ILM peeling Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ILM Flap Transposition Versus ILM Peeling for Macular Holes: a Pilot Study
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : December 1, 2019

Arm Intervention/treatment
Experimental: ILM flap
vitrectomy with ILM flap transposition and gas-tamponade will be performed
Procedure: ILM flap transposition
during ILM flap Transposition, an ILM flap is placed on the macular hole

Active Comparator: ILM peeling
vitrectomy with ILM peeling and gas-tamponade will be performed
Procedure: ILM peeling
during ILM Peeling the ILM is removed around the macular hole




Primary Outcome Measures :
  1. closure of the macular hole [ Time Frame: 3 months ]
    closure of the macular hole will be assessed



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • macular hole with a diameter <400µm

Exclusion Criteria:

  • Prior ILM peeling

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646695


Contacts
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Contact: Oliver Findl, Professor +43 1 91021-84611 hkh.augen.abt@wgkk.at

Locations
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Austria
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Recruiting
Vienna, Austria, 1140
Contact: Oliver Findl, MD, MBA    +43 1 91021 84611    oliver@findl.at   
Sponsors and Collaborators
Vienna Institute for Research in Ocular Surgery
Investigators
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Principal Investigator: Oliver Findl, Professor Head of Department of Ophthalmology, Professor, Principal Investigator

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Responsible Party: Prim. Prof. Dr. Oliver Findl, MBA, Head of Department of Ophthalmology, Professor, Principal Investigator, MBA, Vienna Institute for Research in Ocular Surgery
ClinicalTrials.gov Identifier: NCT03646695     History of Changes
Other Study ID Numbers: ILM flap
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Retinal Perforations
Retinal Diseases
Eye Diseases