Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
180 participants
OBSERVATIONAL
2025-06-26
2025-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Retinal Disease
OCT
A10900 is an optical coherence tomography device
Healthy
OCT
A10900 is an optical coherence tomography device
Glaucoma
OCT
A10900 is an optical coherence tomography device
Corneal Disease
OCT
A10900 is an optical coherence tomography device
Interventions
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OCT
A10900 is an optical coherence tomography device
Eligibility Criteria
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Inclusion Criteria
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
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
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.
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
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;
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
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.
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
22 Years
ALL
Yes
Sponsors
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Optos, PLC
INDUSTRY
Responsible Party
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Locations
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Ketchum Health
Anaheim, California, United States
Eye Care and Laser Surgery of Newton Wellselley
Wellesley Hills, Massachusetts, United States
Charles Retina Institute
Germantown, Tennessee, United States
Countries
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Facility Contacts
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Other Identifiers
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OPT1110
Identifier Type: -
Identifier Source: org_study_id
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