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Causes of Visual Loss in Retinal Disease

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ClinicalTrials.gov Identifier: NCT01613963
Recruitment Status : Unknown
Verified June 2012 by Simon Taylor, Royal Surrey County Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : June 7, 2012
Last Update Posted : June 7, 2012
Sponsor:
Information provided by (Responsible Party):
Simon Taylor, Royal Surrey County Hospital

Brief 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.

Condition or disease Intervention/treatment
Uveitis Scleritis Drug: Immunosuppressive Agents

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.

Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Observational Study of Visual Outcomes in Retinal Disease
Study Start Date : May 2012
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Patients with ocular inflammation
Patients with ocular inflammation
Drug: Immunosuppressive Agents
Treatment with systemic corticosteroids and/or immunosuppressive agents Treatment with local corticosteroids and other drugs
Other Names:
  • Prednisolone
  • Azathioprine
  • Methotrexate
  • Mycophenolate mofetil
  • Cyclosporine A
  • Infliximab
  • Adalimumab
  • Etanercept
  • Rituximab



Primary Outcome Measures :
  1. Visual acuity at 5 years [ Time Frame: 5 years ]
    Best-corrected visual acuity at 5 years


Secondary Outcome Measures :
  1. Visual acuity at 10 years [ Time Frame: 10 years ]
    Best corrected visual acuity at 10 years

  2. Source of referral [ Time Frame: Baseline ]
    Categorised as A&E/GP referral/Optician referral/Tertiary referral

  3. Laterality [ Time Frame: Baseline ]

    Categorised as:

    Right eye/Left eye/Bilateral


  4. Anatomical diagnosis [ Time Frame: Baseline ]

    Cateogorised as:

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


  5. Aetiological diagnosis [ Time Frame: Baseline ]

    Diagnosed as:

    Viral / Bacterial / Fungal / Parasitic / Inflammatory / Malignant


  6. Associated systemic disease [ Time Frame: Baseline ]
    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

  7. Complications of disease and causes of visual loss at 5 years [ Time Frame: 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


  8. Complications of disease and causes of visual loss at 10 years [ Time Frame: 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


  9. Complications of disease and causes of visual loss [ Time Frame: Up to 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


  10. Treatment measures employed [ Time Frame: Up to 10 years ]

    Categorised into:

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


  11. Complications of disease and treatment [ Time Frame: Up to 10 years ]

    Categorised into:

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

  12. Surgical procedures [ Time Frame: Up to 10 years ]
    List and dates of any intraocular surgery performed during the study

  13. Burden of disease - appointments [ Time Frame: Up to 10 years ]
    Number of outpatient appointments over the course of the study

  14. Burden of disease - outpatient procedures [ Time Frame: Up to 10 years ]
    Number of outpatient procedures over the course of the study

  15. Burden of disease - inpatient procedures [ Time Frame: Up to 10 years ]
    Number of inpatient procedures over the course of the study

  16. Blind registration [ Time Frame: Up to 10 years ]
    Year of any registration as partially sighted or blind



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with ocular inflammation
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01613963


Locations
United Kingdom
Royal Surrey County Hospital
Guildford, UK, United Kingdom, GU2 7XX
Moorfields Eye Hospital
London, United Kingdom, EC1V 2PD
Sponsors and Collaborators
Royal Surrey County Hospital
Investigators
Principal Investigator: Simon RJ Taylor, PhD FRCOphth Royal Surrey County Hospital

Responsible Party: Simon Taylor, Senior Lecturer & Consultant Ophthalmic Surgeon, Royal Surrey County Hospital
ClinicalTrials.gov Identifier: NCT01613963     History of Changes
Other Study ID Numbers: 12DEV0010
First Posted: June 7, 2012    Key Record Dates
Last Update Posted: June 7, 2012
Last Verified: June 2012

Keywords provided by Simon Taylor, Royal Surrey County Hospital:
Uveitis
Scleritis

Additional relevant MeSH terms:
Uveitis
Retinal Diseases
Scleritis
Uveal Diseases
Eye Diseases
Scleral Diseases
Mycophenolic Acid
Azathioprine
Immunosuppressive Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites
Antimetabolites, Antineoplastic
Antirheumatic Agents