Evaluation and Treatment of Patients With Retinal Disease

NCT00005784 | Completed

• 2 other identifiers: 00013900-EI-0139
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study offers evaluation and treatment for patients with certain diseases of the retina (the layer of light-sensitive tissue that lines the inside of the eyeball). The protocol is not designed to test new treatments; rather, patients will receive the current standard of care for his or her specific condition. The purpose of the study is twofold: 1) to allow National Eye Institute physicians to increase their knowledge of retinal eye diseases and identify possible new avenues of research in this area; and 2) to establish a pool of patients who may be eligible for new studies as they are developed. (Participants in this protocol will not be required to join a new study; the decision will be voluntary.) Patients with diabetic retinopathy, age-related macular degeneration, vascular occlusive disease, central serous retinopathy or another retinal disease may be eligible for this study. Candidates will be screened with a medical history, brief physical examination, thorough eye examination and blood test. The eye examination includes measurements of eye pressure and visual acuity (ability to see the vision chart), examination of the pupils and eye movements, and dilation of the pupils to examine the lens and retina. Patients will also undergo fundus photography and fluorescein angiography, as follows:

• Fundus photography - Special photographs of the inside of the eye to help evaluate the status of the retina and evaluate changes that may occur in the future. From 2 to 20 pictures may be taken, depending on the eye condition. The camera flashes a bright light into the eye for each picture.
• Fluorescein angiography - Procedure to evaluate the eye's blood vessels. A yellow dye injected into an arm vein travels to the blood vessels in the eyes. Pictures of the retina are taken using a camera that flashes a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating possible blood vessel abnormality. Participants will be followed at least 3 years. Follow-up visits are scheduled according to the standard of care for the individual patient's eye problem. It is estimated that most patients will have from one to four follow-up visits each year. Vision will be checked at each visit, and some of the screening tests described above may be repeated to follow the progress of disease and evaluate the response to treatment.

Conditions

Retinal Disease

Keywords

Macular Degeneration; Diabetic Retinopathy; Vascular Occlusive Disease; Central Serous Retinopathy; Rare/Unknown Retinal Disease; Retinal Disease; Age-Related Macular Degeneration

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Each study participant must have the ability to understand and sign an informed consent form.
• Patients with diabetic retinopathy and age-related macular degeneration.
• Patients with vascular occlusive disease, central serous retinopathy, or rare/unknown retinal disease.

You may not qualify if:

• Patients will be excluded from this study if they are unable or unwilling to give informed consent or they are unwilling to be followed and treated at the NEI Clinical Center for at least the next 3 years.

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Retinal Diseases; Macular Degeneration; Diabetic Retinopathy; Central Serous Chorioretinopathy

Condition Hierarchy (Ancestors)

Eye Diseases; Retinal Degeneration; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 3, 2000
• First Posted: June 5, 2000
• Study Start: May 31, 2000
• Study Completion: August 8, 2008
• Last Updated: July 2, 2017

Record last verified: 2008-08-08

Locations

US (1)