Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-01-06 @ 3:10 PM
Study NCT ID:
NCT02821767
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2016-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Natural History, Pathogenesis, and Outcome of Ocular Disorders
Sponsor:
National Eye Institute (NEI)
Organization:
Study Overview
Official Title:
Studies of the Natural History, Pathogenesis and Outcome of Ocular Disorders
Status:
RECRUITING
Status Verified Date:
2025-12-19
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
...
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.
...
Detailed 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 collect data and specimens generated
through clinical care procedures. Through this primary objective, the secondary objectives (establish a resource of patients with ocular conditions to facilitate recruitment into new research protocols at the NEI, gain additional knowledge about the course of specific ocular diseases and characterize the natural history of such diseases (to generate hypotheses for future clinical research studies), and evaluate the effects of standard of care treatments) may be achieved.
Objective: The primary objective of this protocol is to collect data and specimens generated
through clinical care procedures. Through this primary objective, the secondary objectives (establish a resource of patients with ocular conditions to facilitate recruitment into new research protocols at the NEI, gain additional knowledge about the course of specific ocular diseases and characterize the natural history of such diseases (to generate hypotheses for future clinical research studies), and evaluate the effects of standard of care treatments) may be achieved.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 16-EI-0134 | None | None | View |