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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02879084
Other study ID # 2017-3170
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 2016
Est. completion date December 2020

Study information

Verified date January 2021
Source CHU de Quebec-Universite Laval
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 during an uncomplicated intermediate uveitis specifically and 3) describe the variation in time of RNFL thickness during the two types of uveitis.


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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
Canada Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement. CHU de Québec Québec

Sponsors (1)

Lead Sponsor Collaborator
CHU de Quebec-Universite Laval

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Retinal Nerve Fiber Layer Thickness in anterior uveitis At time 0
Primary Retinal Nerve Fiber Layer Thickness in intermediate uveitis At time 0
Primary Change from Baseline Retinal Nerve Fiber Layer Thickness in anterior uveitis at 4 to 6 weeks
Primary Change from Baseline Retinal Nerve Fiber Layer Thickness in intermediate uveitis at 4 months
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