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CompletedNCT03465865Updated Feb 13, 2025

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

An observational study in Macular Hole, sponsored by Vienna Institute for Research in Ocular Surgery. Completed at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-13.

Sponsored by Vienna Institute for Research in Ocular Surgery · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
41
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Macular Hole

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients are invited for a follow-up one year after ILM-flap transposition for surgical repair of macular holes

Inclusion criteria

  • history of ILM-flap transposition

Exclusion criteria

Exclusion Criteria:

  • none
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
41 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • Deviceoptical coherence tomography

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

    Also known as: visual acuity test

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What researchers measure

Primary outcomes

  1. OCT

    macular hole closure is assessed with optical coherence tomography

    Time frame: 5 minutes

Secondary outcomes

  1. visual acuity

    visual acuity describes functional outcomes of the eye

    Time frame: 5 minutes

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Study locations

1 site
  • VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital
    Vienna, 1140, Austria
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03465865
Lead sponsor
Vienna Institute for Research in Ocular Surgery
Responsible party
Prim. Prof. Dr. Oliver Findl, MBA (head of the department of ophthalmology, professor, MBA, Vienna Institute for Research in Ocular Surgery) — Principal investigator
First posted
Mar 14, 2018
Start date
Sep 1, 2017
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024
Last update
Feb 13, 2025

Study contacts

Oliver Findl, Prof
principal investigator · VIROS at Hanuschkrankenhaus Vienna
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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