UveitisNCT01983488
Clinical Outcome in Uveitis
An observational study of Uveitis, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study is aimed at investigating the long term clinical outcome of patients with uveitis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Uveitis
- How many people
- 231 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2011to 1 Dec 2019
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient data will be gathered from the uveitis clinic at Moorfields Eye Hospital.
Who may be able to join
- Clinical Diagnosis of Uveitis.
Who cannot join
- No follow-up data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Outcome and Causes of Visual Loss in Uveitis
This study is aimed at investigating the long term clinical outcome of patients with uveitis.
Read the detailed description
Patients will be included if they are treated for uveitis and have had repeat follow-up. Data will be gathered from the entire length of the patients follow-up.
The main outcome measures will be:
Change from baseline of Best corrected visual acuity (BCVA)at 10 years Causes of vision loss (≤6/15, VL) and severe vision loss (≤6/60, SVL) at 10 years Number of clinical visits at 10 years.
- Conditions
- Uveitis
- Keywords
- Uveitis, Vision Loss
- Medical subject headings
- Uveitis, Vision Disorders
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 | Patient with a clinical diagnosis of Uveitis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity
Recorded repeat best corrected visual acuity at intervals throughout the length of follow-up.
Measured: up to 10 years
Secondary outcomes (1)
Causes of visual loss
Record any ocular changes related to permanent visual loss under 6/12 and severe visual loss under 6/60.
Measured: First follow-up, years 1,2,5,10, Final follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startSep 2011
- Primary completion1 Dec 2018
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sue Lightman, Moorfields Eye Hospital NHS Foundation Trust
- Investigators
- Sue Lightman, PhD,FRCOphth, Principal investigator, Moorfields Eye Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01983488
- Sponsor's protocol ID
- LIGS10201
- Status last verified
- Feb 2021
- First submitted
- 3 Nov 2013
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Rothova A, Suttorp-van Schulten MS, Frits Treffers W, Kijlstra A. Causes and frequency of blindness in patients with intraocular inflammatory disease. Br J Ophthalmol. 1996 Apr;80(4):332-6. doi: 10.1136/bjo.80.4.332.
PubMed 8703885Bodaghi B, Cassoux N, Wechsler B, Hannouche D, Fardeau C, Papo T, Huong DL, Piette JC, LeHoang P. Chronic severe uveitis: etiology and visual outcome in 927 patients from a single center. Medicine (Baltimore). 2001 Jul;80(4):263-70. doi: 10.1097/00005792-200107000-00005. No abstract available.
PubMed 11470987
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome and Causes of Visual Loss in Uveitis
- ClinicalTrials.gov ID
- NCT01983488
- Acronym / sponsor ID
- LIGS10201
- Conditions
- Uveitis
- Keywords
- Uveitis, Vision Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 14 Nov 2013 (estimated)
- 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.
This study is aimed at investigating the long term clinical outcome of patients with uveitis.
Detailed description
Patients will be included if they are treated for uveitis and have had repeat follow-up. Data will be gathered from the entire length of the patients follow-up.
The main outcome measures will be:
Change from baseline of Best corrected visual acuity (BCVA)at 10 years Causes of vision loss (≤6/15, VL) and severe vision loss (≤6/60, SVL) at 10 years Number of clinical visits at 10 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Uveitis | – | –Patient with a clinical diagnosis of Uveitis. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient data will be gathered from the uveitis clinic at Moorfields Eye Hospital.
Key inclusion criteria (1 listed)
- Clinical Diagnosis of Uveitis.
Key exclusion criteria (1 listed)
- No follow-up data.
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
Best Corrected Visual Acuity
Time frame: up to 10 years
Recorded repeat best corrected visual acuity at intervals throughout the length of follow-up.
1 secondary outcome
Causes of visual loss
Time frame: First follow-up, years 1,2,5,10, Final follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Background: PubMed 8703885Rothova A, Suttorp-van Schulten MS, Frits Treffers W, Kijlstra A. Causes and frequency of blindness in patients with intraocular inflammatory disease. Br J Ophthalmol. 1996 Apr;80(4):332-6. doi: 10.1136/bjo.80.4.332.
- Background: PubMed 11470987Bodaghi B, Cassoux N, Wechsler B, Hannouche D, Fardeau C, Papo T, Huong DL, Piette JC, LeHoang P. Chronic severe uveitis: etiology and visual outcome in 927 patients from a single center. Medicine (Baltimore). 2001 Jul;80(4):263-70. doi: 10.1097/00005792-200107000-00005. No abstract available.
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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.
Sue Lightman, PhD,FRCOphth principal investigator
Moorfields Eye Hospital NHS Foundation Trust
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 Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 1 Mar 2021. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Best Corrected Visual Acuity (time frame: up to 10 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 NCT01983488, which also lists 2 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 1 Mar 2021.