- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03187613
Correlation of Metamorphopsia and Aniseikonia to Retinal Shift Following Retinal Detachment Surgery
September 27, 2021 updated by: Helse Stavanger HF
Individuals operated for rhegmatogenous retinal detachment will be prospectively evaluated for postoperative retinal shift.
Fundus autofluorescence will be used to evaluate retinal shift that will be correlated to visual acuity, metamorphopsia, aniseikonia, and stereopsis.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
38
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
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Stavanger, Norway, 4016
- Stavanger University Hospital, Department of Ophthalmology
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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
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Individuals treated at Stavanger University Hospital
Description
Inclusion Criteria:
- Acute rhegmatogenous retinal detachment, fovea detached, able to signe
Exclusion Criteria:
- Secondary retinal detachment like tractional, serous or with ora serrata dialysis, fovea on
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
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Retinal shift
Time Frame: 2 years
|
Measured on fundus autofluorescence
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2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual acuity
Time Frame: 6 and 24 months
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Best Corrected Visual Acuity
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6 and 24 months
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Metamorphopsia
Time Frame: 6 and 24 months
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M-Chart
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6 and 24 months
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Aniseikonia
Time Frame: 6 and 24 months
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New Aniseikonia Test
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6 and 24 months
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Stereopsis
Time Frame: 6 and 24 months
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Titmus Test
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6 and 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Vegard Forsaa, MD, Helse Stavanger HF
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Thomseth VM, Ushakova A, Krohn J, Utheim TP, Austeng D, Fossen K, Varhaug P, Malmin A, Skeiseid L, Tharaldsen A, Lindtjorn B, Johannesen H, Juul J, Forsaa VA. STRUCTURAL PATHOLOGY AFTER RETINAL DETACHMENT: Multicolor Confocal Scanning Laser Ophthalmoscopy Versus Color Fundus Photography. Retina. 2021 Sep 1;41(9):1958-1965. doi: 10.1097/IAE.0000000000003113.
- Thomseth VM, Engelsvold DH, Ushakova A, Forsaa VA. EN FACE IMAGING OF OUTER RETINAL PATHOLOGY AFTER RETINAL DETACHMENT. Retina. 2021 Feb 1;41(2):324-330. doi: 10.1097/IAE.0000000000002814.
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)
June 21, 2017
Primary Completion (Actual)
December 31, 2020
Study Completion (Actual)
December 31, 2020
Study Registration Dates
First Submitted
June 13, 2017
First Submitted That Met QC Criteria
June 13, 2017
First Posted (Actual)
June 15, 2017
Study Record Updates
Last Update Posted (Actual)
September 28, 2021
Last Update Submitted That Met QC Criteria
September 27, 2021
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017/730 REK
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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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