- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02879084
Variations in Retinal Nerve Fiber Layer Thickness During Uncomplicated Anterior and Intermediate Uveitis
January 25, 2021 updated by: CHU de Quebec-Universite Laval
This study investigates the variations in the retinal nerve fiber layer (RNFL) thickness during uncomplicated anterior and intermediate uveitis, respectively.
The objectives are to 1 ) confirm the RNFL thickening during an uncomplicated anterior uveitis as described in the literature, 2) measure the RNFL thickness during an uncomplicated intermediate uveitis specifically and 3) describe the variation in time of RNFL thickness during the two types of uveitis.
Study Overview
Status
Completed
Conditions
Detailed Description
Thirty six individuals (18 with anterior uveitis and 18 with intermediate uveitis) will be recruited at the Centre universitaire d'ophtalmologie du CHU de Québec.
RNFL thickness will be measured with optical coherence tomography at 3 times.
For anterior uveitis, the RNFL thickness will be measured at presentation, 1 week and 4 to 6 weeks.
For intermediate uveitis, the RNFL thickness will be measured at presentation, 4 to 6 weeks and 4 months.
The initial thickness will be studied for each type of uveitis and progression over time will be studied also for each type of uveitis.
Study Type
Observational
Enrollment (Actual)
36
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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Québec, Canada, G1S 4LB
- Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement. CHU de Québec
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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
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult of 18 years old or more with anterior or intermediate uncomplicated uveitis
Description
Inclusion Criteria:
- 18 years old or more
- anterior uncomplicated uveitis or intermediate uncomplicated uveitis
Exclusion Criteria:
- history of uveitis in the past, other than the actual uveitis
- history of ophthalmologic pathology with potential impact on retinal nerve fiber layer thickness
- optic nerve or macular clinically apparent edema
- history of glaucoma or other optic neuropathy
- suspected or confirmed multiple sclerosis
- ocular hypertension (intraocular pressure more than 22 mmHg)
- reduced optical coherence tomography signal (lower than 7) on the Cirrus HD-OCT
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 |
Time Frame |
---|---|
Retinal Nerve Fiber Layer Thickness in anterior uveitis
Time Frame: At time 0
|
At time 0
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Retinal Nerve Fiber Layer Thickness in intermediate uveitis
Time Frame: At time 0
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At time 0
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Change from Baseline Retinal Nerve Fiber Layer Thickness in anterior uveitis
Time Frame: at 4 to 6 weeks
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at 4 to 6 weeks
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Change from Baseline Retinal Nerve Fiber Layer Thickness in intermediate uveitis
Time Frame: at 4 months
|
at 4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Simon Couture, Doctor, Centre de recherche du CHU de Québec : Université Laval
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)
August 1, 2016
Primary Completion (ACTUAL)
December 1, 2020
Study Completion (ACTUAL)
December 1, 2020
Study Registration Dates
First Submitted
August 4, 2016
First Submitted That Met QC Criteria
August 22, 2016
First Posted (ESTIMATE)
August 25, 2016
Study Record Updates
Last Update Posted (ACTUAL)
January 27, 2021
Last Update Submitted That Met QC Criteria
January 25, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-3170
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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