StargardtsAOSLONCT01866371
High Resolution Retinal Imaging
An observational study of Stargardts and Retinitis Pigmentosa, run by University of Pennsylvania at 1 site in United States.
Trial summary
Studying the morphology and function of the normal and diseased retina in vivo is needed for advancing the detection, diagnosis, and treatment of retinal disease. This protocol uses an adaptive optics scanning laser ophthalmoscope (AOSLO) to image the normal and diseased retina with individual cellular resolution… Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stargardts, Retinitis Pigmentosa, Age-related Macular Degeneration
- What is being tested?
- Retinal imaging
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Dec 2031
- 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 7 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Individuals age 7 and older will be recruited for purposes of this study. Adults must have the capacity to give informed consent. Subjects age 7 to 17 will need parent/guardian consent to participate in the study. Subjects aged 7 to 17 will need to assent to participate in the study. We will recruit subjects with both normal (disease-free) retinas and subjects with retinal degenerations including Leber's Congenital Amaurosis, Stargardt's Dystrophy, retinitis pigmentosa, age-related macular degeneration, Choroideremia, Geographic Atrophy, etc. Subjects will not be excluded based on ethnic or racial background; we expect that enrollment will be split evenly between males and females.
Who may be able to join
- Males or females age 7 years or older.
- Parental/guardian permission (informed consent) and if appropriate, child assent. Child subjects age 7-17 must give assent.
- Reasonable compliance with an imaging protocol as determined by the study personnel.
Who cannot join
- Individuals that are at risk to acute glaucoma.
- Individuals that are photophobic and experience adverse psychological reactions to flashes of light.
- Ocular opacities, high refractive error, and high frequency of nystagmus as determined by the study team.
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
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Jessica IW Morgan, PhD, 215-614-4196, jwmorgan@pennmedicine.upenn.edu
About this study
Studying the morphology and function of the normal and diseased retina in vivo is needed for advancing the detection, diagnosis, and treatment of retinal disease. This protocol uses an adaptive optics scanning laser ophthalmoscope (AOSLO) to image the normal and diseased retina with individual cellular resolution non-invasively. The primary objective of this study is to obtain and analyze high-resolution images of the retina, in particular by imaging the cone photoreceptor mosaic, the retinal vasculature and other retinal layers. The study design will involve case-control studies, where cases are followed over time. Subjects age 7 and older may be invited to participate. The main research procedure involves retinal imaging with the AOSLO. The primary endpoint is the observation of differences in retinal images between subjects with and without retinal diseases. These changes will be quantified by examining the cell density, size, spacing and regularity of the cone photoreceptor mosaic, as well as examining the differences between other retinal layers.
- Conditions
- Stargardts, Retinitis Pigmentosa, Age-related Macular Degeneration, Choroideremia, Geographic Atrophy
- Being tested
- Retinal imaging
- Keywords
- Retina, imaging, retinal degeneration
- Medical subject headings
- Retinitis Pigmentosa, Macular Degeneration, Choroideremia, Geographic Atrophy, Retinal Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retinal imagingProcedure or surgery
Retinal imaging procedures include adaptive optics imaging, optical coherence tomography and fundus photography.
| Study group | Role | What they receive |
|---|---|---|
| Retinal degeneration | This group will include patients with retinal degeneration and vision abnormalities. The group will participate in retinal imaging procedures including adaptive optics imaging, optical coherence tomography and fundus photography. Vision may be assessed using microperimetry, visual fields, and visual acuity. Receives: Procedure: Retinal imaging | |
| Normal control | This group will include individuals without retinal degeneration. The group will participate in retinal imaging procedures including adaptive optics imaging, optical coherence tomography and fundus photography. Vision may be assessed using microperimetry, visual fields, and visual acuity. Receives: Procedure: Retinal imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
high-resolution images of retina
The primary objective of this study is to obtain and analyze high-resolution images of the retina in normal and diseased eyes non-invasively.
Measured: 1 day (initial visit)
Secondary outcomes (1)
Cone mosaic parameters
Imaging the cone photoreceptor mosaic, and analyzing cell density, size, spacing, regularity, and other mosaic parameters in normal retina compared to diseased retina.
Measured: 1 day (initial visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2030 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StargardtsStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Jessica IW Morgan, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01866371
- Sponsor's protocol ID
- 817019
- Other IDs
- R24EY019861
- Acronym
- AOSLO
- Status last verified
- Apr 2026
- First submitted
- 28 May 2013
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Morgan JI, Han G, Klinman E, Maguire WM, Chung DC, Maguire AM, Bennett J. High-resolution adaptive optics retinal imaging of cellular structure in choroideremia. Invest Ophthalmol Vis Sci. 2014 Sep 4;55(10):6381-97. doi: 10.1167/iovs.13-13454.
PubMed 25190651
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Resolution Retinal Imaging
- ClinicalTrials.gov ID
- NCT01866371
- Acronym / sponsor ID
- AOSLO / 817019
- Conditions
- Stargardts, Retinitis Pigmentosa, Age-related Macular Degeneration, Choroideremia, Geographic Atrophy
- Keywords
- Retina, imaging, retinal degeneration
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- May 2013
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 31 May 2013 (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.
Studying the morphology and function of the normal and diseased retina in vivo is needed for advancing the detection, diagnosis, and treatment of retinal disease. This protocol uses an adaptive optics scanning laser ophthalmoscope (AOSLO) to image the normal and diseased retina with individual cellular resolution non-invasively. The primary objective of this study is to obtain and analyze high-resolution images of the retina, in particular by imaging the cone photoreceptor mosaic, the retinal vasculature and other retinal layers. The study design will involve case-control studies, where cases are followed over time. Subjects age 7 and older may be invited to participate. The main research procedure involves retinal imaging with the AOSLO. The primary endpoint is the observation of differences in retinal images between subjects with and without retinal diseases. These changes will be quantified by examining the cell density, size, spacing and regularity of the cone photoreceptor mosaic, as well as examining the differences between other retinal layers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retinal degeneration | – | Procedure: Retinal imagingThis group will include patients with retinal degeneration and vision abnormalities. The group will participate in retinal imaging procedures including adaptive optics imaging, optical coherence tomography and fundus photography. Vision may be assessed using microperimetry, visual fields, and visual acuity. |
| Normal control | – | Procedure: Retinal imagingThis group will include individuals without retinal degeneration. The group will participate in retinal imaging procedures including adaptive optics imaging, optical coherence tomography and fundus photography. Vision may be assessed using microperimetry, visual fields, and visual acuity. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals age 7 and older will be recruited for purposes of this study. Adults must have the capacity to give informed consent. Subjects age 7 to 17 will need parent/guardian consent to participate in the study. Subjects aged 7 to 17 will need to assent to participate in the study. We will recruit subjects with both normal (disease-free) retinas and subjects with retinal degenerations including Leber's Congenital Amaurosis, Stargardt's Dystrophy, retinitis pigmentosa, age-related macular degeneration, Choroideremia, Geographic Atrophy, etc. Subjects will not be excluded based on ethnic or racial background; we expect that enrollment will be split evenly between males and females.
Key inclusion criteria (3 listed)
- Males or females age 7 years or older.
- Parental/guardian permission (informed consent) and if appropriate, child assent. Child subjects age 7-17 must give assent.
- Reasonable compliance with an imaging protocol as determined by the study personnel.
Key exclusion criteria (3 listed)
- Individuals that are at risk to acute glaucoma.
- Individuals that are photophobic and experience adverse psychological reactions to flashes of light.
- Ocular opacities, high refractive error, and high frequency of nystagmus as determined by the study team.
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 |
|---|---|---|
| Retinal imagingRetinal imaging procedures include adaptive optics imaging, optical coherence tomography and fundus photography. | Procedure or surgery | Normal control, Retinal degeneration |
Primary outcome
high-resolution images of retina
Time frame: 1 day (initial visit)
The primary objective of this study is to obtain and analyze high-resolution images of the retina in normal and diseased eyes non-invasively.
1 secondary outcome
Cone mosaic parameters
Time frame: 1 day (initial visit)
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 5 May 2026.
- Derived from this study: PubMed 25190651Morgan JI, Han G, Klinman E, Maguire WM, Chung DC, Maguire AM, Bennett J. High-resolution adaptive optics retinal imaging of cellular structure in choroideremia. Invest Ophthalmol Vis Sci. 2014 Sep 4;55(10):6381-97. doi: 10.1167/iovs.13-13454.
Related trials for Stargardts
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A Phase 1/2, First-in-Human Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of a Subretinal Injection of SB-007 in Subjects With Stargardt Disease (STGD1)
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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.
Jessica IW Morgan, PhD principal investigator
University of Pennsylvania
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 Stargardts and Retinitis Pigmentosa, run by University of Pennsylvania 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 3 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: looking for participants now, as of the sponsor's last update on 5 May 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 Jessica IW Morgan, PhD (215-614-4196, jwmorgan@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
high-resolution images of retina (time frame: 1 day (initial visit)). 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 NCT01866371, which also lists 1 linked publication.
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 5 May 2026.