OCT data collection from healthy and diseased eyes (A10900)
Official title: Data Gathering for A10900
Run by Optos, PLC · NCT07149740 · Data updated 2026-11-12
This project will collect Optical Coherence Tomography (OCT) scans from adults 22 and older who have retinal disease, glaucoma, corneal conditions, or are healthy to build a reference dataset for A10900.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 22 Years and up |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | Optos, PLC Industry-sponsored |
| Locations | 4 sites (Anaheim, California and 3 other locations) |
| Status | Recruiting |
| Started | June 26, 2025 |
| Main results expected | May 1, 2026 |
| Study ends | May 1, 2026 |
| Registry record updated | February 13, 2026 |
| Trial ID | NCT07149740 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 22 or older who can give informed consent, have best-corrected visual acuity of 20/400 or better in the study eye, can tolerate OCT imaging, and either have a diagnosed retinal pathology or are enrolled as healthy controls.
✕Probably not a fit
People who cannot tolerate ophthalmic imaging, who cannot produce acceptable OCT images due to media opacity or other issues, or who have conditions the investigator deems incompatible are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational effort gathers OCT images from multiple clinical sites to create a labeled dataset of normal and diseased eyes. Participants include adults (22+) who can consent and produce usable OCT scans, with a target group of retinal pathology cases plus healthy controls and other ocular diagnoses. Imaging is performed using standard OCT protocols and images that are unreadable due to media opacity or intolerance to imaging are excluded. Data will be used by the sponsor, Optos, PLC, to support technical development and validation of A10900.
Why it matters
Potential benefit: If successful, the collected OCT dataset could improve future imaging tools or algorithms that help doctors detect and monitor retinal and other eye diseases.
How similar studies have gone: Similar OCT imaging collections have been used successfully to train and validate imaging devices and diagnostic algorithms, so this data-gathering approach is well established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion/Exclusion Criteria Inclusion Criteria for Retinal Disease 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. BCVA 20/400 or better in the study eye 4. Participants presenting at the site with retinal disease 5. Diagnosis of some type of retinal pathology by investigator, may include, but not limited to: Macular Degeneration (including participants with drusen and geographic atrophy and choroidal neovascularization), Diabetic Macular Edema, Diabetic Retinopathy, Macular Hole, Epiretinal Membrane, Central Serous Retinopathy and others Exclusion Criteria for Retinal Disease Group 1. Participants unable to tolerate ophthalmic imaging 2. Participants not able to obtain acceptable OCT images due to ocular media opacity or other reasons 3. 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 4. 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; Inclusion Criteria for Glaucoma 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. BCVA 20/40 or better in the study eye 4. 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: 1. 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; 2. Glaucoma hemi-field test "outside normal limits." 5. Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities: 1. Diffuse thinning, focal narrowing, or notching of the neuroretinal rim, especially at the inferior or superior poles with or without disc hemorrhage; 2. Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue Exclusion Criteria for Glaucoma Group 1. Participants unable to tolerate ophthalmic imaging 2. Participants not able to obtain acceptable OCT images due to ocular media opacity or other reasons 3. 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 4. 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 5. 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. Exclusion Criteria for Corneal Group 1. Participants unable to tolerate ophthalmic imaging 2. 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 3. Participant with ocular media not sufficiently clear to obtain acceptable OCT images. Inclusion Criteria for Normal 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 normal eyes (Cataracts, LASIK, PRK, and peripheral pathology that does not affect the posterior pole region, for example lattice and peripheral drusen, are allowed). 4. BCVA 20/40 or better (each eye) 5. Participant is able to comply with the study procedures Exclusion Criteria for Normal Group 1. Participants unable to tolerate ophthalmic imaging 2. 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 3. Participant with ocular media not sufficiently clear to obtain acceptable OCT images 4. History of leukemia, dementia or multiple sclerosis
Where it's running
-
Ketchum Health
Anaheim, California, United States Recruiting -
Eye Disease Consultants, LLC
West Hartford, Connecticut, United States Recruiting -
Charles Retina Institute
Germantown, Tennessee, United States Recruiting -
Eye Care and Laser Surgery of Newton Wellselley
Wellesley Hills, Massachusetts, United States Completed
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.