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

Sponsor
Vienna Institute for Research in Ocular Surgery (Other)
Overall Status
Recruiting
CT.gov ID
NCT03465865
Collaborator
(none)
20
Enrollment
1
Location
52
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: optical coherence tomography

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Visual Acuity and Optical Coherence Tomography One Year After ILM-flap Transposition for Surgical Repair of Macular Holes
Actual Study Start Date :
Sep 1, 2017
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
ILM-flap

Patients after surgical repair of macular holes with ILM-flap transposition are invitied to a follow-up for optical coherence tomography and visual acuity testing one year after surgery

Device: optical coherence tomography
optical coherence tomography enables diagosis of macular structures and therefore provides information on macular hole closure.
Other Names:
  • visual acuity test

    		•

    Outcome Measures

    Primary Outcome Measures

    1. OCT [5 minutes]

      macular hole closure is assessed with optical coherence tomography

    Secondary Outcome Measures

    1. visual acuity [5 minutes]

      visual acuity describes functional outcomes of the eye

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • history of ILM-flap transposition
    Exclusion Criteria:
    • none

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital Vienna Austria 1140

    Sponsors and Collaborators

    • Vienna Institute for Research in Ocular Surgery

    Investigators

    • Principal Investigator: Oliver Findl, Prof, VIROS at Hanuschkrankenhaus Vienna

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Prim. Prof. Dr. Oliver Findl, MBA, head of the department of ophthalmology, professor, MBA, Vienna Institute for Research in Ocular Surgery
    ClinicalTrials.gov Identifier:
    NCT03465865
    Other Study ID Numbers:
    • ILMflap
    First Posted:
    Mar 14, 2018
    Last Update Posted:
    Jan 12, 2021
    Last Verified:
    Jan 1, 2021
    Additional relevant MeSH terms:
    Retinal Perforations

    Study Results

    No Results Posted as of Jan 12, 2021