Causes of Visual Loss in Retinal Disease

Sponsor

Royal Surrey County Hospital NHS Foundation Trust (Other)

Overall Status

Unknown status

CT.gov ID

NCT01613963

Collaborator

(none)

2,000

Enrollment

Locations

Duration (Months)

1000

Patients Per Site

142.2

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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 Design

Study Type:

Observational

Anticipated Enrollment :

2000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Observational Study of Visual Outcomes in Retinal Disease

Study Start Date :

May 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2012

Anticipated Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	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

Arm

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:

Prednisolone

Azathioprine

Methotrexate

Mycophenolate mofetil

Cyclosporine A

Infliximab

Adalimumab

Etanercept

Rituximab

Outcome Measures

Primary Outcome Measures

Visual acuity at 5 years [5 years]
Best-corrected visual acuity at 5 years

Secondary Outcome Measures

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