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UveitisNCT01613963

Causes of Visual Loss in Retinal Disease

An observational study of Uveitis and Scleritis, run by Royal Surrey County Hospital NHS Foundation Trust at 2 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a study of visual outcomes in retinal disease that seeks to identify the causes of visual loss. This data will be used to predict which patients are at risk of losing vision and how they can be better treated. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Uveitis, Scleritis
What is being tested?
Immunosuppressive Agents
How many people
2,000 participants
Where
2 sitesUnited Kingdom
Study dates
May 2012to Dec 2012
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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients with ocular inflammation

Who may be able to join

  • patients with a diagnosis of ocular inflammation
  • patients with at least 6 months of follow-up

Who cannot join

  • patients without a diagnosis of ocular inflammation
  • patients with less than 6 months of follow-up

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

  • Royal Surrey County Hospital

    Guildford, UK, GU2 7XX

  • Moorfields Eye Hospital

    London, London, EC1V 2PD

Other trials in United Kingdom

About this study

Official title: Observational Study of Visual Outcomes in Retinal Disease

This is a study of visual outcomes in retinal disease that seeks to identify the causes of visual loss. This data will be used to predict which patients are at risk of losing vision and how they can be better treated.

Read the detailed description

This is a study of visual outcomes in retinal disease. It is an observational study of patients who have been seen in the retinal clinic, and involves a retrospective casenotes analysis to identify patients who have suffered visual loss and the reason for that visual loss. These data will be analysed to enable the identification of factors that predict visual loss in patients who present earlier in the course of their disease.

Conditions
Uveitis, Scleritis
Being tested
Immunosuppressive Agents
Keywords
Uveitis, Scleritis
Medical subject headings
Uveitis, Scleritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Immunosuppressive AgentsDrug

    Also called Prednisolone, Azathioprine, Methotrexate, Mycophenolate mofetil

    Treatment with systemic corticosteroids and/or immunosuppressive agents Treatment with local corticosteroids and other drugs

Study groups in NCT01613963
Study groupRoleWhat they receive
Patients with ocular inflammationPatients with ocular inflammation
Receives: Drug: Immunosuppressive Agents

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual acuity at 5 years

    Best-corrected visual acuity at 5 years

    Measured: 5 years

Secondary outcomes (16)

  1. Visual acuity at 10 years

    Best corrected visual acuity at 10 years

    Measured: 10 years

  2. Source of referral

    Categorised as A\&E/GP referral/Optician referral/Tertiary referral

    Measured: Baseline

  3. Laterality

    Categorised as:

    Right eye/Left eye/Bilateral

    Measured: Baseline

  4. Anatomical diagnosis

    Cateogorised as:

    Acute anterior uveitis / Chronic anterior uveitis / Fuchs heterochromic cyclitis / Intermediate uveitis / Pars planitis / Posterior Uveitis / Panuveitis / Episcleritis / Scleritis

    Measured: Baseline

  5. Aetiological diagnosis

    Diagnosed as:

    Viral / Bacterial / Fungal / Parasitic / Inflammatory / Malignant

    Measured: Baseline

  6. Associated systemic disease

    Any associated systemic disease, e.g. HLA-B27 associated disease, Behcet's disease, multiple sclerosis, Vogt-Koyanagi-Harada syndrome, rheumatoid arthritis, collagen vascular disease, tuberculosis, granulomatosis with polyangiitis

    Measured: Baseline

  7. Complications of disease and causes of visual loss at 5 years

    Categorised into:

    Corneal clarity problems / cataract / vitreous debris / retinal detachment / cystoid macular edema / retinal pigment epithelium atrophy / macular scarring / epiretinal membrane / macular hole / steroid response / glaucoma / other optic neuropathy / hypotony \& phthisis / other

    Measured: 5 years

  8. Complications of disease and causes of visual loss at 10 years

    Categorised into:

    Corneal clarity problems / cataract / vitreous debris / retinal detachment / cystoid macular edema / retinal pigment epithelium atrophy / macular scarring / epiretinal membrane / macular hole / steroid response / glaucoma / other optic neuropathy / hypotony \& phthisis / other

    Measured: 10 years

  9. Complications of disease and causes of visual loss

    Categorised into:

    Corneal clarity problems / cataract / vitreous debris / retinal detachment / cystoid macular edema / retinal pigment epithelium atrophy / macular scarring / epiretinal membrane / macular hole / steroid response / glaucoma / other optic neuropathy / hypotony \& phthisis / other

    Measured: Up to 10 years

  10. Treatment measures employed

    Categorised into:

    Topical treatment / periocular steroid / intraocular steroid / intraocular other agent / Glaucoma treatment / systemic immunosuppressive agents

    Measured: Up to 10 years

  11. Complications of disease and treatment

    Categorised into:

    1. Local complications: Raised intraocular pressure / cataract / endophthalmitis / other
    2. Systemic complications: Diabetes / hypertension / cholesterol / liver function / bone density loss / other

    Measured: Up to 10 years

  12. Surgical procedures

    List and dates of any intraocular surgery performed during the study

    Measured: Up to 10 years

  13. Burden of disease - appointments

    Number of outpatient appointments over the course of the study

    Measured: Up to 10 years

  14. Burden of disease - outpatient procedures

    Number of outpatient procedures over the course of the study

    Measured: Up to 10 years

  15. Burden of disease - inpatient procedures

    Number of inpatient procedures over the course of the study

    Measured: Up to 10 years

  16. Blind registration

    Year of any registration as partially sighted or blind

    Measured: Up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionDec 2012 (estimated)
  4. Study completionDec 2012 (estimated)

Resources

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
Retrospective
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01613963
Sponsor's protocol ID
12DEV0010
Status last verified
Jun 2012
First submitted
29 May 2012
Last updated
7 Jun 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Uveitis and Scleritis, run by Royal Surrey County Hospital NHS Foundation Trust at 2 sites 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 2 inclusion and 2 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 7 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

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?

Visual acuity at 5 years (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 NCT01613963.

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 7 Jun 2012.

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