Natural History, Pathogenesis, and Outcome of Ocular Disorders

Eye Disease Clinical Trial

Official title:

Studies of the Natural History, Pathogenesis and Outcome of Ocular Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02821767
• Other study ID #: 160134
• Secondary ID: 16-EI-0134
• Status: Recruiting
• Start date: August 3, 2016
• Est. completion date: July 1, 2026

Study information

• Verified date: February 14, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Awilda V Holland, R.N.
• Phone: (301) 435-1831
• Email: aholland[@]mail.nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Background:

The National Eye Institute (NEI) wants to evaluate and provide standard treatment to people with eye diseases.

Objective:

To examine and treat people with eye diseases and learn more about eye diseases and how they are inherited.

Eligibility:

People with eye diseases who can give consent or have a guardian who can consent for them. Asymptomatic first-degree relatives willing to provide a blood sample may also be enrolled for the purpose of genetic testing.

Design:

Participants will be screened with an eye exam.

Participants will have 1-12 visits per year depending on their eye disease for up to 5 years. Visits last about 4 hours and could include:

Medical and family history

Physical exam

Eye exam and photography.

Oculography: They put on contact lenses or goggles. They watch spots on a computer

screen for 20-30 minutes.

Electrooculography: Small metal disks are placed on the skin next to both eyes. They look left

and right in the dark and light for about 30 minutes.

Electroretinography: They sit in the dark with their eyes patched. A small metal disk is taped

to the forehead. After 30 minutes, the patches are removed and contact lenses put in. They

watch flashing lights.

Fluorescein angiography: A needle guides a thin plastic tube into an arm vein. A dye is

injected through the tube and travels up the blood vessels in the eyes. Pictures are taken of the

eyes.

Immunosuppressive treatment

Eye cell sample: Samples are obtained from swabbing, pressing paper on, or taking a small

biopsy sample from the surface of the eye.

Blood tests

Skin, tear, urine, saliva, stool, or hair sample

Exam under anesthesia for some children

At each visit participants could get medications, eye drops, eye injections, laser treatments, or surgery.

Description:

The National Eye Institute (NEI) is conducting a study to evaluate and provide standard treatment to participants with various diagnosed and undiagnosed ocular conditions. Objective: The primary objective of this protocol is to provide short term follow-up of patients, usually in conjunction with a referring physician. In addition, this protocol allows clinicians at the NEI to maintain their expertise in evaluating and treating various eye disorders for which there may not be specific research studies. The knowledge gained may lead to ideas for future clinical research studies. Study Population: The number of participants to be enrolled has no logical upper limit, but will be set to 1,000 patients with ocular diseases. Design: This is an observational natural history study of multiple ocular diseases and their progression and physiology. Outcome Measures: No formal outcomes will be measured; however, the clinical assessments of enrolled participants can be used to measure the response to standard treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 100 Years

Eligibility

• INCLUSION CRITERIA:

To be eligible, the following inclusion criteria must be met, where applicable.

1. Have a diagnosed, undiagnosed or suspected eye disease.

2. Have the ability to understand and sign an informed consent or have a parent/legal guardian do so if they are minor children or a legal guardian to provide consent for adults without consent capacity.

EXCLUSION CRITERIA:

A participant is not eligible if any of the following exclusion criteria are present.

1. Are unwilling to give informed consent or assent when applicable.

2. Are unwilling or unable to be followed as clinically indicated.

3. Have a systemic disease that compromises the ability of NEI clinicians to provide adequate ophthalmologic examination or treatment.

Related Conditions & MeSH terms

• Eye Disease
• Eye Diseases

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	No formal outcomes will be measured; however, the clinical assessments of enrolled participants can be used to measure the response to standard treatment.	response to standard care of treatment	ongoing

External Links

•   NIH Clinical Center Detailed Web Page