UveitisNCT03889860
Objective Choroidal Thickness Measurements in Uveitis
An observational study of Uveitis, run by Wroclaw Medical University at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Uveitis
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 Sep 2018to 1 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Uveitis patients and matched control group
Who may be able to join
- 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.
Who cannot join
- To the control group - diagnosed uveitis
- In case of all groups:
- inability to give informed consent;
- inability to maintain stable fixation for OCT imaging.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Objective Choroidal Thickness Measurements During Intraocular Inflammation in Uveitis Using Optical Coherence Tomography
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.
- Conditions
- Uveitis
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Uveitis group | Not described | |
| Control group | age and sex matched group to the uveitis group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Submacular choroidal thickness in different stages of the disease
OCT EDI recordings processed with developed by researchers methodology for image processing
Measured: 5 years
Secondary outcomes (6)
ETDRS Visual Acuity
Visual Acuity will be performed with ETDRS charts different for right and left eye
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start1 Sep 2018
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for UveitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Wrocław University of Science and Technology
- Responsible party
- Principal investigator, Joanna Przeździecka-Dołyk, Wroclaw Medical University
- Investigators
- Marta Misiuk-Hojło, Professor, Study chair, Medical University of Wrocław
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889860
- Sponsor's protocol ID
- ST-859 extention
- Status last verified
- Mar 2022
- First submitted
- 23 Mar 2019
- Last updated
- 29 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Intention to share anonymised data of each patient visit in the study
Publications
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.
PubMed 25682177Li 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.
PubMed 23249705Passaglia 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.
PubMed 29600118Davis 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.
PubMed 20719302Keane 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.
PubMed 24835759Madow 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.
PubMed 21652026
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Choroidal Thickness Measurements During Intraocular Inflammation in Uveitis Using Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT03889860
- Acronym / sponsor ID
- ST-859 extention
- Conditions
- Uveitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Collaborators
- Wrocław University of Science and Technology
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uveitis group | – | – |
| Control group | – | –age and sex matched group to the uveitis group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Uveitis patients and matched control group
Key inclusion criteria (8 listed)
- 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):
Key exclusion criteria (4 listed)
- To the control group - diagnosed uveitis
- In case of all groups:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Submacular choroidal thickness in different stages of the disease
Time frame: 5 years
OCT EDI recordings processed with developed by researchers methodology for image processing
6 secondary outcomes
ETDRS Visual Acuity
Time frame: 1 year
The SUN working group grading system for anterior chamber cells
Time frame: 1 year
The SUN working group grading system for anterior chamber flare
Time frame: 1 year
AREDS 2008 Clinical Lens Opacity Grading Procedure
Time frame: 1 year
NIH grading system for vitreous cells
Time frame: 1 year
NIH grading system for vitreous haze
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Background: PubMed 25682177Indaram 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.
- Background: PubMed 23249705Li 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.
- Background: PubMed 29600118Passaglia 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.
- Background: PubMed 20719302Davis 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.
- Background: PubMed 24835759Keane 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.
- Background: PubMed 21652026Madow 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.
- Individual participant dataSharing planned: Undecided. Intention to share anonymised data of each patient visit in the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta Misiuk-Hojło, Professor study chair
Medical University of Wrocław
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uveitis, run by Wroclaw Medical University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Submacular choroidal thickness in different stages of the disease (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03889860, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.