Causes of Visual Loss in Retinal Disease

Uveitis Clinical Trial

Official title:

Observational Study of Visual Outcomes in Retinal Disease

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01613963
• Other study ID #: 12DEV0010
• Status: Enrolling by invitation
• Phase: N/A
• First received: May 29, 2012
• Last updated: June 5, 2012
• Start date: May 2012
• Est. completion date: December 2012

Study information

• Verified date: June 2012
• Source: Royal Surrey County Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2000
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Retinal Diseases
• Scleritis
• Uveitis

Intervention

Drug:
• Immunosuppressive Agents
Treatment with systemic corticosteroids and/or immunosuppressive agents Treatment with local corticosteroids and other drugs

Locations

Country	Name	City	State
United Kingdom	Royal Surrey County Hospital	Guildford	UK
United Kingdom	Moorfields Eye Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Royal Surrey County Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity at 5 years	Best-corrected visual acuity at 5 years	5 years	No
Secondary	Visual acuity at 10 years	Best corrected visual acuity at 10 years	10 years	No
Secondary	Source of referral	Categorised as A&E/GP referral/Optician referral/Tertiary referral	Baseline	No
Secondary	Laterality	Categorised as: Right eye/Left eye/Bilateral	Baseline	No
Secondary	Anatomical diagnosis	Cateogorised as: Acute anterior uveitis / Chronic anterior uveitis / Fuchs heterochromic cyclitis / Intermediate uveitis / Pars planitis / Posterior Uveitis / Panuveitis / Episcleritis / Scleritis	Baseline	No
Secondary	Aetiological diagnosis	Diagnosed as: Viral / Bacterial / Fungal / Parasitic / Inflammatory / Malignant	Baseline	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Treatment measures employed	Categorised into: Topical treatment / periocular steroid / intraocular steroid / intraocular other agent / Glaucoma treatment / systemic immunosuppressive agents	Up to 10 years	No
Secondary	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	No
Secondary	Surgical procedures	List and dates of any intraocular surgery performed during the study	Up to 10 years	No
Secondary	Burden of disease - appointments	Number of outpatient appointments over the course of the study	Up to 10 years	No
Secondary	Burden of disease - outpatient procedures	Number of outpatient procedures over the course of the study	Up to 10 years	No
Secondary	Burden of disease - inpatient procedures	Number of inpatient procedures over the course of the study	Up to 10 years	No
Secondary	Blind registration	Year of any registration as partially sighted or blind	Up to 10 years	No