Anterior UveitisNCT02879084
Variations in Retinal Nerve Fiber Layer Thickness During Uncomplicated Anterior and Intermediate Uveitis
An observational study of Anterior Uveitis and Intermediate Uveitis, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Uveitis, Intermediate Uveitis
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2016to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult of 18 years old or more with anterior or intermediate uncomplicated uveitis
Who may be able to join
- 18 years old or more
- anterior uncomplicated uveitis or intermediate uncomplicated uveitis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement. CHU de Québec
Québec, G1S 4LB
About this study
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.
Read the 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.
- Conditions
- Anterior Uveitis, Intermediate Uveitis
- Medical subject headings
- Uveitis, Anterior, Uveitis, Intermediate
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal Nerve Fiber Layer Thickness in anterior uveitis
Measured: At time 0
Retinal Nerve Fiber Layer Thickness in intermediate uveitis
Measured: At time 0
Change from Baseline Retinal Nerve Fiber Layer Thickness in anterior uveitis
Measured: at 4 to 6 weeks
Change from Baseline Retinal Nerve Fiber Layer Thickness in intermediate uveitis
Measured: at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior UveitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Couture, Doctor, Principal investigator, Centre de recherche du CHU de Québec : Université Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02879084
- Sponsor's protocol ID
- 2017-3170
- Status last verified
- Jan 2021
- First submitted
- 4 Aug 2016
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variations in Retinal Nerve Fiber Layer Thickness During Uncomplicated Anterior and Intermediate Uveitis
- ClinicalTrials.gov ID
- NCT02879084
- Acronym / sponsor ID
- 2017-3170
- Conditions
- Anterior Uveitis, Intermediate Uveitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 25 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult of 18 years old or more with anterior or intermediate uncomplicated uveitis
Key inclusion criteria (2 listed)
- 18 years old or more
- anterior uncomplicated uveitis or intermediate uncomplicated uveitis
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retinal Nerve Fiber Layer Thickness in anterior uveitis
Time frame: At time 0
Retinal Nerve Fiber Layer Thickness in intermediate uveitis
Time frame: At time 0
Change from Baseline Retinal Nerve Fiber Layer Thickness in anterior uveitis
Time frame: at 4 to 6 weeks
Change from Baseline Retinal Nerve Fiber Layer Thickness in intermediate uveitis
Time frame: at 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Couture, Doctor principal investigator
Centre de recherche du CHU de Québec : Université Laval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Uveitis and Intermediate Uveitis, run by CHU de Quebec-Universite Laval at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal Nerve Fiber Layer Thickness in anterior uveitis (time frame: At time 0). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.