NCT02879084

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 25, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

4.3 years

First QC Date

August 4, 2016

Last Update Submit

January 25, 2021

Conditions

Anterior UveitisIntermediate Uveitis

Outcome Measures

Primary Outcomes (4)

  • Retinal Nerve Fiber Layer Thickness in anterior uveitis

    At time 0

  • Retinal Nerve Fiber Layer Thickness in intermediate uveitis

    At time 0

  • Change from Baseline Retinal Nerve Fiber Layer Thickness in anterior uveitis

    at 4 to 6 weeks

  • Change from Baseline Retinal Nerve Fiber Layer Thickness in intermediate uveitis

    at 4 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult of 18 years old or more with anterior or intermediate uncomplicated uveitis

You may qualify if:

  • years old or more
  • anterior uncomplicated uveitis or intermediate uncomplicated uveitis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement. CHU de Québec

Québec, G1S 4LB, Canada

Location

MeSH Terms

Conditions

Uveitis, AnteriorUveitis, Intermediate

Condition Hierarchy (Ancestors)

PanuveitisUveitisUveal DiseasesEye Diseases

Study Officials

  • Simon Couture, Doctor

    Centre de recherche du CHU de Québec : Université Laval

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2016

First Posted

August 25, 2016

Study Start

August 1, 2016

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

January 27, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)