Adaptive Optics Retinal Imaging | NCT02317328

Studies
Adaptive Optics Retinal Imaging

NCT02317328

Sponsor

National Eye Institute (NEI)

Status

Recruiting

Last Update Posted

Jun 16, 2026Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Eye Diseases
Healthy Volunteers

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
15-EI-0020

Status Module

Record Verification Date

Jun 5, 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 20, 2015Actual

Primary Completion Date

Mar 31, 2028Estimated

Completion Date

Mar 31, 2028Estimated

First Submitted Date

Dec 13, 2014

First Submission Date that Met QC Criteria

Dec 13, 2014

First Posted Date

Dec 16, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2026

Last Update Posted Date

Jun 16, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Label	Type	Description	Intervention Names
Affected participants		Participants with ocular conditions
Healthy Volunteers		Healthy volunteers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Qualitative and quantitative assessment of AO images	Qualitative and quantitative assessment of AO images with comparison of normal and diseased states.	ongoing

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

INCLUSION CRITERIA:

Participants will be eligible if they:

Are 12 years of age or older.
Have the ability to cooperate with an eye exam and adaptive optics imaging.
Have the ability to understand and sign an informed consent or have a parent/legal guardian to do so if they are minor children.
Have an eye disease or are a healthy volunteer with a normal eye exam (no visually-significant eye findings on examination).

EXCLUSION CRITERIA:

Participants will not be eligible if:

-They have a condition which prevents adequate images from being obtained (e.g. unstable fixation or media opacity).

EXCLUSION CRITERIA FOR FLUORESCEIN AND/OR INDOCYANINE GREEN IMAGING

Partaicipants are not eligible for fluorescein and/or indocyanine green imaging if they:

Are under 18 years of age.
For participants who will undergo fluorescein imaging have a history of adverse reaction to fluorescein.
For participants who will undergo indocyanine green imaging have a history of adverse reaction to indocyanine green dye, know or suspected allergies to iodine or shellfish.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

120 Years

Standard Ages

ChildAdultOlder Adult

Study Population

500 participants with eye diseases and 500 healthy volunteers will be enrolled.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Daniel W Claus, R.N.	Contact	(301) 451-1621		daniel.claus@nih.gov
Johnny C Tam, Ph.D.	Contact	(301) 435-7821		johnny.tam@nih.gov

Overall Officials

Name	Affiliation	Role
Johnny C Tam, Ph.D.	National Eye Institute (NEI)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Institutes of Health Clinical Center	Recruiting	Bethesda	Maryland	20892	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
1388798	Background	Hendrickson A, Drucker D. The development of parafoveal and mid-peripheral human retina. Behav Brain Res. 1992 Jul 31;49(1):21-31. doi: 10.1016/s0166-4328(05)80191-3.
669891	Background	Wing GL, Blanchard GC, Weiter JJ. The topography and age relationship of lipofuscin concentration in the retinal pigment epithelium. Invest Ophthalmol Vis Sci. 1978 Jul;17(7):601-7.