Retinal ToxicityNCT05643157
Structure and Function of Retinal Disease
A study testing Adaptive Optics - Optical Coherence Tomography (AO-OCT) retinal imaging in people with Retinal Toxicity, run by Indiana University at 1 site in United States.
Trial summary
Current clinical cameras do not allow clinicians to see the cells of the retina. This study will evaluate a new electronic camera's ability to observe the human retina in finer detail. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Toxicity
- What is being tested?
- Adaptive Optics - Optical Coherence Tomography (AO-OCT) retinal imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to 24 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Retinal disease of either inherited retinal degeneration or retinal toxicity
Who cannot join
- Ocular media opacities
- High refractive error
- Pupil dilation imposes a risk to ocular health
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Optometry
Bloomington, Indiana, 47405
About this study
Current clinical cameras do not allow clinicians to see the cells of the retina. This study will evaluate a new electronic camera's ability to observe the human retina in finer detail.
Read the detailed description
This research study will (1) test the ability of a new electronic camera developed in Dr. Miller's laboratory to observe retina in human subjects, and (2) use the camera for observing disease in the eye. This new camera integrates cutting-edge technologies in adaptive optics (AO) and optical coherence tomography (OCT) that enable the camera to capture sharp images. The objective of our study is to find out (1) whether the AO-OCT camera will allow researchers to observe the retina with finer resolution than current clinical cameras, and (2) whether this finer detail is useful for observing the progression of disease in the eye.
To address the second objective, the study will subjects with various disease severity of drusen associated geographic atrophy.
- Conditions
- Retinal Toxicity
- Being tested
- Adaptive Optics - Optical Coherence Tomography (AO-OCT) retinal imaging
- Keywords
- retinal toxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive Optics - Optical Coherence Tomography (AO-OCT) retinal imagingDevice
AO-OCT used in this study is an investigational OCT imaging system. In this instrument, ocular aberration sensing and correction is achieved with a Shack-Hartmann wavefront sensor (SHWS) and deformable mirror, respectively. A pupil camera and fixation target are used to position the participant's head and eye for scanning a particular retinal region within 15 degrees of the fovea. Data collected generally includes AO-OCT volume videos and SHWS measurements of ocular aberrations.
| Study group | Role | What they receive |
|---|---|---|
| Retinal Disease | Experimental | Subjects with either retinal toxicity or inherited retinal degeneration will undergo multimodal clinical imaging and Adaptive Optics Optical Coherence Tomography (AO-OCT) imaging at each study visit to document regions of disease and healthy retina over time. Receives: Device: Adaptive Optics - Optical Coherence Tomography (AO-OCT) retinal imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of photoreceptor and retinal pigment epithelium (RPE) cell layers
Images of the photoreceptor and RPE cell layers taken with clinical instruments and the AO-OCT will be compared.
Measured: 2 years
RPE cell morphology changes
Images will be used to determine the changes in RPE cell morphology in regions of healthy and diseased retina (in subjects with retinal disease).
Measured: 2 years
Cone Photoreceptor Dysfunction
Images will be used to determine changes in cone photoreceptor dysfunction and death
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start1 Nov 2022
- Primary completion24 Feb 2025
- Study completion24 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal ToxicityStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristen Bowles Johnson, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643157
- Sponsor's protocol ID
- 18287
- Status last verified
- Mar 2026
- First submitted
- 8 Nov 2022
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structure and Function of Retinal Disease
- ClinicalTrials.gov ID
- NCT05643157
- Acronym / sponsor ID
- 18287
- Conditions
- Retinal Toxicity
- Keywords
- retinal toxicity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 24 Feb 2025 (actual)
- Study completion
- 24 Feb 2025 (actual)
- First posted
- 8 Dec 2022 (actual)
- 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.
Current clinical cameras do not allow clinicians to see the cells of the retina. This study will evaluate a new electronic camera's ability to observe the human retina in finer detail.
Detailed description
This research study will (1) test the ability of a new electronic camera developed in Dr. Miller's laboratory to observe retina in human subjects, and (2) use the camera for observing disease in the eye. This new camera integrates cutting-edge technologies in adaptive optics (AO) and optical coherence tomography (OCT) that enable the camera to capture sharp images. The objective of our study is to find out (1) whether the AO-OCT camera will allow researchers to observe the retina with finer resolution than current clinical cameras, and (2) whether this finer detail is useful for observing the progression of disease in the eye.
To address the second objective, the study will subjects with various disease severity of drusen associated geographic atrophy.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retinal Disease | Experimental | Device: Adaptive Optics - Optical Coherence Tomography (AO-OCT) retinal imagingSubjects with either retinal toxicity or inherited retinal degeneration will undergo multimodal clinical imaging and Adaptive Optics Optical Coherence Tomography (AO-OCT) imaging at each study visit to document regions of disease and healthy retina over time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Retinal disease of either inherited retinal degeneration or retinal toxicity
Key exclusion criteria (3 listed)
- Ocular media opacities
- High refractive error
- Pupil dilation imposes a risk to ocular health
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptive Optics - Optical Coherence Tomography (AO-OCT) retinal imagingAO-OCT used in this study is an investigational OCT imaging system. In this instrument, ocular aberration sensing and correction is achieved with a Shack-Hartmann wavefront sensor (SHWS) and deformable mirror, respectively. A pupil camera and fixation target are used to position the participant's head and eye for scanning a particular retinal region within 15 degrees of the fovea. Data collected generally includes AO-OCT volume videos and SHWS measurements of ocular aberrations. | Device | Retinal Disease |
Primary outcome
Quality of photoreceptor and retinal pigment epithelium (RPE) cell layers
Time frame: 2 years
Images of the photoreceptor and RPE cell layers taken with clinical instruments and the AO-OCT will be compared.
RPE cell morphology changes
Time frame: 2 years
Images will be used to determine the changes in RPE cell morphology in regions of healthy and diseased retina (in subjects with retinal disease).
Cone Photoreceptor Dysfunction
Time frame: 2 years
Images will be used to determine changes in cone photoreceptor dysfunction and death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
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Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive Optics - Optical Coherence Tomography (AO-OCT) retinal imaging in people with Retinal Toxicity, run by Indiana University 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 12 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of photoreceptor and retinal pigment epithelium (RPE) cell layers (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2026.