Natural History, Pathogenesis, and Outcome of Ocular Disorders
| Status: | Recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/10/2019 |
| Start Date: | June 29, 2016 |
| End Date: | July 1, 2026 |
| Contact: | Awilda V Holland |
| Email: | aholland@nei.nih.gov |
| Phone: | (301) 435-7831 |
Studies of the Natural History, Pathogenesis and Outcome of Ocular Disorders
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
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.
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
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.
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.
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.
- 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
301-496-2563
Phone: 800-411-1222
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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