Retinal DiseaseNCT07149740
Data Gathering for A10900
An observational study of Retinal Disease and Healthy, run by Optos, PLC at 4 sites in United States.
Trial summary
The objective of this study is to gather Optical Coherence Tomography (OCT) data on normal and diseased eyes Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinal Disease, Healthy, Glaucoma
- What is being tested?
- OCT
- Type of treatment
- Medical device
- How many people
- 180 participants
- Where
- 4 sitesUnited States
- Study dates
- 26 Jun 2025to 1 May 2026
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants with healthy, glaucoma, retinal disease and corneal disease located in different geographic locations in the US
Who may be able to join
- Participants 22 years of age or older on the date of informed consent
- Participants able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
- BCVA 20/40 or better in the study eye
- History of Visual field defects within the previous year from the study visit or measured the day of the study visit consistent with glaucomatous optic nerve damage with at least one of the following two findings:
- On pattern deviation (PD), there exists a cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level;
- Glaucoma hemi-field test "outside normal limits."
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- Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities:
- Diffuse thinning, focal narrowing, or notching of the neuroretinal rim, especially at the inferior or superior poles with or without disc hemorrhage;
- Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue
- Participants 22 years of age or older on the date of informed consent
- Participants able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
- Participants presenting at the site with normal eyes (Cataracts, LASIK, PRK, and peripheral pathology that does not affect the posterior pole region, for example lattice and peripheral drusen, are allowed).
- BCVA 20/40 or better (each eye)
- Participant is able to comply with the study procedures
Who cannot join
- Participants unable to tolerate ophthalmic imaging
- Participants not able to obtain acceptable OCT images due to ocular media opacity or other reasons
- Participant has a condition or is in a situation which the investigator feels may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study
- Presence of glaucoma or any ocular pathology other than a retinal pathology in the study eye as determined by self-report and/or investigator assessment at the study visit;
- Participants unable to tolerate ophthalmic imaging
- Participants not able to obtain acceptable OCT images due to ocular media opacity or other reasons
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- Participant has a condition or is in a situation which the investigator feels may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study
- No reliable visual field test result within the previous year from the study visit, defined as fixation losses > 33% or false positives > 33%, or false negatives > 33% in the study eye
- Presence of any ocular pathology except glaucoma in the study eye Inclusion Criteria for Corneal Group
- 1. Participants 22 years of age or older on the date of informed consent 2. Participants able to understand the written informed consent and willing to participate as evidenced by signing the informed consent 3. Participants presenting at the site with corneal disease, for example but not limited to, corneal disorders due to contact lens wear, post-refractive surgery, dry eye, keratoconus 4. Participant is able to comply with the study procedures.
- Participants unable to tolerate ophthalmic imaging
- Participant has a condition or is in a situation which the investigator feels may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study
- Participant with ocular media not sufficiently clear to obtain acceptable OCT images.
- Participants unable to tolerate ophthalmic imaging
- Participant has a condition or is in a situation which the investigator feels may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study
- Participant with ocular media not sufficiently clear to obtain acceptable OCT images
- History of leukemia, dementia or multiple sclerosis
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 3 recruiting
- Recruiting
Ketchum Health
Anaheim, California, 92807
Sue Parke, 714-423-9498, sparker@ketchum.edu
- Recruiting
Charles Retina Institute
Germantown, Tennessee, 38138
Molly Scott, 901-767-4499, mscott@charlesretina.com
- Completed
Eye Care and Laser Surgery of Newton Wellselley
Wellesley Hills, Massachusetts, 02481
- Recruiting
Eye Disease Consultants, LLC
West Hartford, Connecticut, 06107
Matthew Nicholas, MD, PhD, 860-549-2020, matthew.nicholas@eyeconsultants.org
About this study
The objective of this study is to gather Optical Coherence Tomography (OCT) data on normal and diseased eyes
- Conditions
- Retinal Disease, Healthy, Glaucoma, Corneal Diseases
- Being tested
- OCT
- Medical subject headings
- Retinal Diseases, Glaucoma, Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCTDevice
A10900 is an optical coherence tomography device
| Study group | Role | What they receive |
|---|---|---|
| Retinal Disease | Not described Receives: Device: OCT | |
| Healthy | Not described Receives: Device: OCT | |
| Glaucoma | Not described Receives: Device: OCT | |
| Corneal Disease | Not described Receives: Device: OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of OCT Scans
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start26 Jun 2025
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Optos, PLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149740
- Sponsor's protocol ID
- OPT1110
- Status last verified
- Feb 2026
- First submitted
- 11 Jul 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: This is included in the participant's informed consent. Images, demographics, ophthalmic assessments and examinations, visual fields, and ophthalmic and medical history.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Gathering for A10900
- ClinicalTrials.gov ID
- NCT07149740
- Acronym / sponsor ID
- OPT1110
- Conditions
- Retinal Disease, Healthy, Glaucoma, Corneal Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Optos, PLCIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 2 Sep 2025 (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.
The objective of this study is to gather Optical Coherence Tomography (OCT) data on normal and diseased eyes
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Retinal Disease | – | Device: OCT |
| Healthy | – | Device: OCT |
| Glaucoma | – | Device: OCT |
| Corneal Disease | – | Device: OCT |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with healthy, glaucoma, retinal disease and corneal disease located in different geographic locations in the US
Key inclusion criteria (14 listed)
- Participants 22 years of age or older on the date of informed consent
- Participants able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
- BCVA 20/40 or better in the study eye
- History of Visual field defects within the previous year from the study visit or measured the day of the study visit consistent with glaucomatous optic nerve damage with at least one of the following two findings:
- Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities:
Key exclusion criteria (17 listed)
- Participants unable to tolerate ophthalmic imaging
- Participants not able to obtain acceptable OCT images due to ocular media opacity or other reasons
- Participant has a condition or is in a situation which the investigator feels may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study
- Presence of glaucoma or any ocular pathology other than a retinal pathology in the study eye as determined by self-report and/or investigator assessment at the study visit;
- Participants unable to tolerate ophthalmic imaging
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 |
|---|---|---|
| OCTA10900 is an optical coherence tomography device | Device | Corneal Disease, Glaucoma, Healthy, Retinal Disease |
Primary outcome
Number of OCT Scans
Time frame: 1 year
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 13 Feb 2026.
- Individual participant dataSharing planned: Yes. This is included in the participant's informed consent. Images, demographics, ophthalmic assessments and examinations, visual fields, and ophthalmic and medical history.
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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.
Eye Disease Consultants, LLC
West Hartford, United States
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Disease and Healthy, run by Optos, PLC at 4 sites 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 14 inclusion and 17 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 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of OCT Scans (time frame: 1 year). 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 13 Feb 2026.