Objective Choroidal Thickness Measurements in Uveitis

Uveitis Clinical Trial

Official title:

Objective Choroidal Thickness Measurements During Intraocular Inflammation in Uveitis Using Optical Coherence Tomography

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03889860
• Other study ID #: ST-859 extention
• Status: Active, not recruiting
• Start date: September 1, 2018
• Est. completion date: January 1, 2026

Study information

• Verified date: March 2022
• Source: Wroclaw Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Uveitis

Locations

Country	Name	City	State
Poland	Department of Ophthalmology	Wroclaw

Sponsors (2)

Lead Sponsor	Collaborator
Wroclaw Medical University	Wroclaw University of Science and Technology

Country where clinical trial is conducted

Poland, 

References & Publications (6)

Davis JL, Madow B, Cornett J, Stratton R, Hess D, Porciatti V, Feuer WJ. Scale for photographic grading of vitreous haze in uveitis. Am J Ophthalmol. 2010 Nov;150(5):637-641.e1. doi: 10.1016/j.ajo.2010.05.036. Epub 2010 Aug 16. — View Citation

Indaram M, Agrón E, Clemons TE, Sperduto RD, Wong WT, Ferris FL 3rd, Chew EY; Age-Related Eye Disease Study Research Group. Changes in lens opacities on the age-related eye disease study grading scale predict progression to cataract surgery and vision loss: age-related eye disease study report no. 34. Ophthalmology. 2015 May;122(5):888-96. doi: 10.1016/j.ophtha.2014.12.037. Epub 2015 Feb 11. — View Citation

Keane PA, Karampelas M, Sim DA, Sadda SR, Tufail A, Sen HN, Nussenblatt RB, Dick AD, Lee RW, Murray PI, Pavesio CE, Denniston AK. Objective measurement of vitreous inflammation using optical coherence tomography. Ophthalmology. 2014 Sep;121(9):1706-14. doi: 10.1016/j.ophtha.2014.03.006. Epub 2014 May 15. — View Citation

Li Y, Lowder C, Zhang X, Huang D. Anterior chamber cell grading by optical coherence tomography. Invest Ophthalmol Vis Sci. 2013 Jan 9;54(1):258-65. doi: 10.1167/iovs.12-10477. — View Citation

Madow B, Galor A, Feuer WJ, Altaweel MM, Davis JL. Validation of a photographic vitreous haze grading technique for clinical trials in uveitis. Am J Ophthalmol. 2011 Aug;152(2):170-176.e1. doi: 10.1016/j.ajo.2011.01.058. Epub 2011 Jun 8. — View Citation

Passaglia CL, Arvaneh T, Greenberg E, Richards D, Madow B. Automated Method of Grading Vitreous Haze in Patients With Uveitis for Clinical Trials. Transl Vis Sci Technol. 2018 Mar 23;7(2):10. doi: 10.1167/tvst.7.2.10. eCollection 2018 Mar. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Submacular choroidal thickness in different stages of the disease	OCT EDI recordings processed with developed by researchers methodology for image processing	5 years
Secondary	ETDRS Visual Acuity	Visual Acuity will be performed with ETDRS charts different for right and left eye	1 year
Secondary	The SUN working group grading system for anterior chamber cells	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.	1 year
Secondary	The SUN working group grading system for anterior chamber flare	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.	1 year
Secondary	AREDS 2008 Clinical Lens Opacity Grading Procedure	Using AREDS system for classifying cataracts from photographs: AREDS Report No. 4 the lens opacity will be graded	1 year
Secondary	NIH grading system for vitreous cells	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.	1 year
Secondary	NIH grading system for vitreous haze	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.	1 year