Causes of Visual Loss in Retinal Disease

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.

Study Overview

• Status: Unknown
• Conditions: Uveitis; Scleritis
• Intervention / Treatment: 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
• Enrollment (Anticipated): 2000

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, EC1V 2PD
    • Moorfields Eye Hospital
  • UK
    • Guildford, UK, United Kingdom, GU2 7XX
      • Royal Surrey County Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with ocular inflammation

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity at 5 years	Best-corrected visual acuity at 5 years	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity at 10 years	Best corrected visual acuity at 10 years	10 years
Source of referral	Categorised as A&E/GP referral/Optician referral/Tertiary referral	Baseline
Laterality	Categorised as: Right eye/Left eye/Bilateral	Baseline
Anatomical diagnosis	Cateogorised as: Acute anterior uveitis / Chronic anterior uveitis / Fuchs heterochromic cyclitis / Intermediate uveitis / Pars planitis / Posterior Uveitis / Panuveitis / Episcleritis / Scleritis	Baseline
Aetiological diagnosis	Diagnosed as: Viral / Bacterial / Fungal / Parasitic / Inflammatory / Malignant	Baseline
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	Baseline
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	5 years
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	10 years
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	Up to 10 years
Treatment measures employed	Categorised into: Topical treatment / periocular steroid / intraocular steroid / intraocular other agent / Glaucoma treatment / systemic immunosuppressive agents	Up to 10 years
Complications of disease and treatment	Categorised into: Local complications: Raised intraocular pressure / cataract / endophthalmitis / other; Systemic complications: Diabetes / hypertension / cholesterol / liver function / bone density loss / other	Up to 10 years
Surgical procedures	List and dates of any intraocular surgery performed during the study	Up to 10 years
Burden of disease - appointments	Number of outpatient appointments over the course of the study	Up to 10 years
Burden of disease - outpatient procedures	Number of outpatient procedures over the course of the study	Up to 10 years
Burden of disease - inpatient procedures	Number of inpatient procedures over the course of the study	Up to 10 years
Blind registration	Year of any registration as partially sighted or blind	Up to 10 years

Collaborators and Investigators

• Sponsor: Royal Surrey County Hospital NHS Foundation Trust
• Investigators: Principal Investigator: Simon RJ Taylor, PhD FRCOphth, Royal Surrey County Hospital NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: May 29, 2012
• First Submitted That Met QC Criteria: June 5, 2012
• First Posted (Estimate): June 7, 2012

Study Record Updates

• Last Update Posted (Estimate): June 7, 2012
• Last Update Submitted That Met QC Criteria: June 5, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Uveitis; Scleritis
• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Scleral Diseases; Retinal Diseases; Uveitis; Scleritis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunologic Factors; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dermatologic Agents; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Reproductive Control Agents; Antitubercular Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Folic Acid Antagonists; Antibiotics, Antitubercular; Calcineurin Inhibitors; Prednisolone; Etanercept; Adalimumab; Methotrexate; Infliximab; Azathioprine; Mycophenolic Acid; Cyclosporine; Cyclosporins; Immunosuppressive Agents
• Other Study ID Numbers: 12DEV0010