Clinical trial NCT03889860: Objective Choroidal Thickness Measurements in Uveitis
Official title: Objective Choroidal Thickness Measurements During Intraocular Inflammation in Uveitis Using Optical Coherence Tomography
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Uveitis
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
Collaborators: name: Wrocław University of Science and Technology
First posted: 2019-03-26
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Uveitis patients and matched control group

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Submacular choroidal thickness in different stages of the disease
timeFrame: 5 years
Secondary outcomes:
measure: ETDRS Visual Acuity
timeFrame: 1 year
measure: The SUN working group grading system for anterior chamber cells
timeFrame: 1 year
measure: The SUN working group grading system for anterior chamber flare
timeFrame: 1 year
measure: AREDS 2008 Clinical Lens Opacity Grading Procedure
timeFrame: 1 year
measure: NIH grading system for vitreous cells
timeFrame: 1 year
measure: NIH grading system for vitreous haze
timeFrame: 1 year
Other outcomes:
Locations:
city: Wrocław
country: Poland
facility: Department of Ophthalmology
Study officials:
affiliation: Medical University of Wrocław
name: Marta Misiuk-Hojło, Professor
role: STUDY_CHAIR
References:
citation: Indaram M, Agron 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.
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.
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.
citation: 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.
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.
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.