NCT03889860

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2019

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

March 29, 2022

Status Verified

March 1, 2022

Enrollment Period

6.3 years

First QC Date

March 23, 2019

Last Update Submit

March 27, 2022

Conditions

Uveitis

Outcome Measures

Primary Outcomes (1)

  • Submacular choroidal thickness in different stages of the disease

    OCT EDI recordings processed with developed by researchers methodology for image processing

    5 years

Secondary Outcomes (6)

  • ETDRS Visual Acuity

    1 year

  • The SUN working group grading system for anterior chamber cells

    1 year

  • The SUN working group grading system for anterior chamber flare

    1 year

  • AREDS 2008 Clinical Lens Opacity Grading Procedure

    1 year

  • NIH grading system for vitreous cells

    1 year

  • +1 more secondary outcomes

Study Arms (2)

Uveitis group

Control group

age and sex matched group to the uveitis group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Uveitis patients and matched control group

You may qualify if:

  • 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+ anterior chamber cells;
  • \>1+ vitreous haze;
  • presence of vitreous cells;
  • presence of blood in anterior chamber;
  • presence of blood in vitreous;
  • presence of aqueous or vitreous pigment.

You may not qualify if:

  • To the control group - diagnosed uveitis
  • In case of all groups:
  • inability to give informed consent;
  • inability to maintain stable fixation for OCT imaging.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology

Wroclaw, 54-622, Poland

Location

Related Publications (6)

  • 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.

    PMID: 25682177BACKGROUND

  • 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.

    PMID: 23249705BACKGROUND

  • 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.

    PMID: 29600118BACKGROUND

  • 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.

    PMID: 20719302BACKGROUND

  • 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.

    PMID: 24835759BACKGROUND

  • 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.

    PMID: 21652026BACKGROUND

MeSH Terms

Conditions

Uveitis

Condition Hierarchy (Ancestors)

Uveal DiseasesEye Diseases

Study Officials

  • Marta Misiuk-Hojło, Professor

    Medical University of Wrocław

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 23, 2019

First Posted

March 26, 2019

Study Start

September 1, 2018

Primary Completion

January 1, 2025

Study Completion

January 1, 2026

Last Updated

March 29, 2022

Record last verified: 2022-03

Locations

PL(1)