Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-31 @ 11:43 PM
Study NCT ID:
NCT02317328
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2014-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adaptive Optics Retinal Imaging
Sponsor:
National Eye Institute (NEI)
Organization:
Study Overview
Official Title:
Adaptive Optics Retinal Imaging
Status:
RECRUITING
Status Verified Date:
2025-12-22
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:
\- By the time diseases of the retina are detected, serious damage has often already been done. Researchers want to find better ways of viewing the retina. One way called adaptive optics may help detect problems earlier.
Objectives:
\- To study if adaptive optics can help find better ways to diagnose, treat, and manage retinal diseases.
Eligibility:
* People over age 12 with an eye disease.
* Healthy volunteers over age 12.
Design:
* Participants will be screened with medical history and eye exams. These may include dilating pupils and taking pictures of the eyes.
* Participants will have 1 or more study visits. They will have:
* Medical and eye history.
* Questions about their medications.
* Eye exam including pupil dilation.
* Adaptive optics imaging. After dilation, participants sit still while looking into an adaptive optics instrument. They look at specific places and images are taken of their retina.
* They may also have:
* More images.
* Perimetry. Participants look into a lens and press a button when they see a light.
* Color vision tests.
* Electroretinogram. Participants will get numbing eye drops and special contact lenses. A small metal electrode will be put on their forehead. They will look at flashing lights and try not to blink.
\- By the time diseases of the retina are detected, serious damage has often already been done. Researchers want to find better ways of viewing the retina. One way called adaptive optics may help detect problems earlier.
Objectives:
\- To study if adaptive optics can help find better ways to diagnose, treat, and manage retinal diseases.
Eligibility:
* People over age 12 with an eye disease.
* Healthy volunteers over age 12.
Design:
* Participants will be screened with medical history and eye exams. These may include dilating pupils and taking pictures of the eyes.
* Participants will have 1 or more study visits. They will have:
* Medical and eye history.
* Questions about their medications.
* Eye exam including pupil dilation.
* Adaptive optics imaging. After dilation, participants sit still while looking into an adaptive optics instrument. They look at specific places and images are taken of their retina.
* They may also have:
* More images.
* Perimetry. Participants look into a lens and press a button when they see a light.
* Color vision tests.
* Electroretinogram. Participants will get numbing eye drops and special contact lenses. A small metal electrode will be put on their forehead. They will look at flashing lights and try not to blink.
Detailed Description:
Objective: The objective of this protocol is to collect and assess adaptive optics (AO) retinal images of normal and diseased eyes.
Study Population: Three hundred and fifty (350) participants with eye diseases and 250 normal volunteers will be enrolled.
Design: This is an observational protocol which will enroll 350 participants with various eye diseases and 250 age-matched healthy volunteers over five years. In general, participants will undergo a complete ophthalmic examination including assessments of visual acuity, intraocular pressure, and a dilated ocular examination. Imaging will be performed using adaptive optics instruments deployed in the NEI Eye Clinic.
Outcome Measures: The primary outcome for this protocol is qualitative and quantitative assessment of the AO images with comparisons of normal and diseased states.
Study Population: Three hundred and fifty (350) participants with eye diseases and 250 normal volunteers will be enrolled.
Design: This is an observational protocol which will enroll 350 participants with various eye diseases and 250 age-matched healthy volunteers over five years. In general, participants will undergo a complete ophthalmic examination including assessments of visual acuity, intraocular pressure, and a dilated ocular examination. Imaging will be performed using adaptive optics instruments deployed in the NEI Eye Clinic.
Outcome Measures: The primary outcome for this protocol is qualitative and quantitative assessment of the AO images with comparisons of normal and diseased states.
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 |
|---|---|---|---|---|
| 15-EI-0020 | None | None | View |