- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04883697
Retrospective Evaluation of Risk Factors for Lower Outcomes After Vitrectomy With ILM Flap Technique
May 6, 2021 updated by: Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
Retrospective Evaluation of Risk Factors for Lower Outcomes After Vitrectomy With ILM Flap
A retrospective review of medical charts of patients having undergone vitrectomy with ILM Peeling and ILM flap technique for macular hole repair.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A retrospective review of medical charts of patients having undergone vitrectomy with ILM Peeling and ILM flap technique for macular hole repair.
Pre- and postoperative OCT and visual acuity in the time period up to 6 months after surgery are reviewed and possible risk factors for failed macular hole closure or lower visual acuity outcome after surgery are assessed.
Study Type
Observational
Enrollment (Actual)
71
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Vienna, Austria, 1140
- Vienna Institute for Research in Ocular Surgery
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 105 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
all patieints have undergone vitrectomy with ILM peeling and ILM flap technique in the time period form 1.1.2015
to 31.4.2020 for macular hole repair
Description
Inclusion Criteria:
- Vitrectomy with ILM peeling and ILM flap technique in the time period form 1.1.2015 to 31.4.2020
- Age 18 or older
Exclusion Criteria:
- Age <18
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
visual acuity
Time Frame: change between visual acuity 2-6 months postoperative to baseline
|
best corrected distance visual acuity
|
change between visual acuity 2-6 months postoperative to baseline
|
|
macular hole closure
Time Frame: 2-6 months postoperative
|
closure of the macular hole assesed with OCT
|
2-6 months postoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Oliver Findl, Vienna Institute for Research in Ocular Surgery
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2021
Primary Completion (ACTUAL)
May 1, 2021
Study Completion (ACTUAL)
May 1, 2021
Study Registration Dates
First Submitted
May 1, 2021
First Submitted That Met QC Criteria
May 6, 2021
First Posted (ACTUAL)
May 12, 2021
Study Record Updates
Last Update Posted (ACTUAL)
May 12, 2021
Last Update Submitted That Met QC Criteria
May 6, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RAI
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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