Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03465865
Recruitment Status : Recruiting
First Posted : March 14, 2018
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery

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
Macular Hole 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.

Layout table for study information
Study Type : Observational
Estimated 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 : September 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Group/Cohort 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 Name: visual acuity test




Primary Outcome Measures :
  1. OCT [ Time Frame: 5 minutes ]
    macular hole closure is assessed with optical coherence tomography


Secondary Outcome Measures :
  1. visual acuity [ Time Frame: 5 minutes ]
    visual acuity describes functional outcomes of the eye



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
Criteria

Inclusion Criteria:

  • history of ILM-flap transposition

Exclusion Criteria:

  • none

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): NCT03465865


Contacts
Layout table for location contacts
Contact: Oliver Findl, Prof. +43 1 91021-84611 oliver.findl@wgkk.at
Contact: Christoph Leisser, MD +43 1 91021-84611 christoph.leisser@wgkk.at

Locations
Layout table for location information
Austria
VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital Recruiting
Vienna, Austria, 1140
Contact: Oliver Findl    0431910210    oliver.findl@wgkk.at   
Contact: Christoph Leisser    0431910210    christoph.leisser@wgkk.at   
Sponsors and Collaborators
Vienna Institute for Research in Ocular Surgery
Investigators
Layout table for investigator information
Principal Investigator: Oliver Findl, Prof VIROS at Hanuschkrankenhaus Vienna

Layout table for additonal information
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     History of Changes
Other Study ID Numbers: ILMflap
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Retinal Perforations
Retinal Diseases
Eye Diseases