Causes of Visual Loss in Retinal Disease

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Simon Taylor, Royal Surrey County Hospital
ClinicalTrials.gov Identifier:
NCT01613963
First received: May 29, 2012
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

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 Intervention
Uveitis
Scleritis
Drug: Immunosuppressive Agents

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Observational Study of Visual Outcomes in Retinal Disease

Resource links provided by NLM:


Further study details as provided by Royal Surrey County Hospital:

Primary Outcome Measures:
  • Visual acuity at 5 years [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Best-corrected visual acuity at 5 years


Secondary Outcome Measures:
  • Visual acuity at 10 years [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Best corrected visual acuity at 10 years

  • Source of referral [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Categorised as A&E/GP referral/Optician referral/Tertiary referral

  • Laterality [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    Categorised as:

    Right eye/Left eye/Bilateral


  • Anatomical diagnosis [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    Cateogorised as:

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


  • Aetiological diagnosis [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    Diagnosed as:

    Viral / Bacterial / Fungal / Parasitic / Inflammatory / Malignant


  • Associated systemic disease [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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

  • Complications of disease and causes of visual loss at 5 years [ Time Frame: 5 years ] [ Designated as safety issue: No ]

    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


  • Complications of disease and causes of visual loss at 10 years [ Time Frame: 10 years ] [ Designated as safety issue: No ]

    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


  • Complications of disease and causes of visual loss [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

    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


  • Treatment measures employed [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

    Categorised into:

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


  • Complications of disease and treatment [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

    Categorised into:

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

  • Surgical procedures [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    List and dates of any intraocular surgery performed during the study

  • Burden of disease - appointments [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    Number of outpatient appointments over the course of the study

  • Burden of disease - outpatient procedures [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    Number of outpatient procedures over the course of the study

  • Burden of disease - inpatient procedures [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    Number of inpatient procedures over the course of the study

  • Blind registration [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    Year of any registration as partially sighted or blind


Estimated Enrollment: 2000
Study Start Date: May 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: May 29, 2012
Last Updated: June 5, 2012
Health Authority: United Kingdom: National Health Service

Keywords provided by Royal Surrey County Hospital:
Uveitis
Scleritis

Additional relevant MeSH terms:
Uveitis
Retinal Diseases
Scleritis
Uveal Diseases
Eye Diseases
Scleral Diseases
Mycophenolate mofetil
Immunosuppressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014