Objective Choroidal Thickness Measurements in Uveitis

Active, not recruiting

• Conditions: Uveitis

• Registration Number: NCT03889860
• Lead Sponsor: Wroclaw Medical University

Brief Summary

Optical Coherence Tomography (OCT) machines are non-contact instruments that can provide micrometer scale imaging of biological tissue. Applying the image processing allows us to automatically measure the choroidal thickness with good interclass correlation coefficient to the manual measurements.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2019-03-23
• Study First Submitted QC: 2019-03-23
• Study First Posted: 2019-03-26
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-27
• Last Update Posted: 2022-03-29
• Primary Completion: 2025-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• To the control group - ability to perform OCT examination

• To the uveitis group - with one or more of the following clinical features (as indicators for active state of the disease):

  1. >1+ anterior chamber cells;
  2. >1+ vitreous haze;
  3. presence of vitreous cells;
  4. presence of blood in anterior chamber;
  5. presence of blood in vitreous;
  6. presence of aqueous or vitreous pigment.

Exclusion Criteria

• To the control group - diagnosed uveitis

• In case of all groups:

  1. inability to give informed consent;
  2. inability to maintain stable fixation for OCT imaging.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Submacular choroidal thickness in different stages of the disease	5 years	OCT EDI recordings processed with developed by researchers methodology for image processing

Secondary Outcome Measures

Name	Time	Method
The SUN working group grading system for anterior chamber flare	1 year	At each visit anterior chamber will be examined to assess anterior chamber flare (1mm x 1mm slit beam in height and width, when thrown at an angle of 45-60°). The observed changes will be used to determine the grade according to the SUN criteria.
NIH grading system for vitreous haze	1 year	At each visit vitreous will be examined to assess vitreous haze. The recorded of clarity of posterior pole funduscopy will be used to determine the grade according to the NIH criteria.
NIH grading system for vitreous cells	1 year	At each visit vitreous will be examined to assess vitreous cells (1mm x 3mm slit beam in anterior vitreous). The recorded number of cells will be used to determine the grade according to the NIH criteria.
ETDRS Visual Acuity	1 year	Visual Acuity will be performed with ETDRS charts different for right and left eye
The SUN working group grading system for anterior chamber cells	1 year	At each visit anterior chamber will be examined to assess anterior chamber cells (1mm x 1mm slit beam in height and width, when thrown at an angle of 45-60°). The recorded number of cells will be used to determine the grade according to the SUN criteria.
AREDS 2008 Clinical Lens Opacity Grading Procedure	1 year	Using AREDS system for classifying cataracts from photographs: AREDS Report No. 4 the lens opacity will be graded

Trial Locations

Locations (1)

Department of Ophthalmology; 🇵🇱 Wrocław, Poland