Eye DiseasesNCT02317328
Adaptive Optics Retinal Imaging
An observational study of Eye Diseases and Healthy Volunteers, run by National Eye Institute (NEI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Eye Diseases, Healthy Volunteers
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2015to 31 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 120 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 500 participants with eye diseases and 500 healthy volunteers will be enrolled.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Eye Diseases, Healthy Volunteers
- Keywords
- Eye Disease, Natural History
- Medical subject headings
- Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Affected participants | Participants with ocular conditions | |
| Healthy Volunteers | Healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative and quantitative assessment of AO images
Qualitative and quantitative assessment of AO images with comparison of normal and diseased states.
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2014 (estimated)
- Study start20 Feb 2015
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Eye DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Johnny C Tam, Ph.D., Principal investigator, National Eye Institute (NEI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02317328
- Sponsor's protocol ID
- 150020
- Other IDs
- 15-EI-0020
- Status last verified
- 6 Aug 2026
- First submitted
- 13 Dec 2014
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 1388798Wing 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.
PubMed 669891Fotedar R, Wang JJ, Burlutsky G, Morgan IG, Rose K, Wong TY, Mitchell P. Distribution of axial length and ocular biometry measured using partial coherence laser interferometry (IOL Master) in an older white population. Ophthalmology. 2010 Mar;117(3):417-23. doi: 10.1016/j.ophtha.2009.07.028. Epub 2010 Jan 19.
PubMed 20031227
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Optics Retinal Imaging
- ClinicalTrials.gov ID
- NCT02317328
- Acronym / sponsor ID
- 150020
- Conditions
- Eye Diseases, Healthy Volunteers
- Keywords
- Eye Disease, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 20 Feb 2015 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 16 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Affected participants | – | –Participants with ocular conditions |
| Healthy Volunteers | – | –Healthy volunteers |
Who may qualify
- Ages
- 12 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 500 participants with eye diseases and 500 healthy volunteers will be enrolled.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (7 listed)
- -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
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Qualitative and quantitative assessment of AO images
Time frame: ongoing
Qualitative and quantitative assessment of AO images with comparison of normal and diseased states.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 1388798Hendrickson 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.
- Background: PubMed 669891Wing 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.
- Background: PubMed 20031227Fotedar R, Wang JJ, Burlutsky G, Morgan IG, Rose K, Wong TY, Mitchell P. Distribution of axial length and ocular biometry measured using partial coherence laser interferometry (IOL Master) in an older white population. Ophthalmology. 2010 Mar;117(3):417-23. doi: 10.1016/j.ophtha.2009.07.028. Epub 2010 Jan 19.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Johnny C Tam, Ph.D. principal investigator
National Eye Institute (NEI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eye Diseases and Healthy Volunteers, run by National Eye Institute (NEI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel W Claus, R.N. ((301) 451-1621, daniel.claus@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative and quantitative assessment of AO images (time frame: ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02317328, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.