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Retinal Investigation Using Optos OCT Device

Clinical Investigation of Optos OCT in Patients with Retinal Pathologies

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06846151
Enrollment
120
Registered
2025-02-25
Start date
2025-05-31
Completion date
2026-01-31
Last updated
2025-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AMD - Age-Related Macular Degeneration, Control Patients, Diabetic Retinopathy, Retinitis Pigmentosa (RP)

Brief summary

Retinal investigation using OCT with control and diseased eyes

Interventions

DEVICEretinal functional imaging

this is a proof of concept study

Sponsors

Optos, PLC
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

all participants receive a single intervention at a single point in time

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Male or female participants 18 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed. 2. Participants who understand the study and patient information sheet and can follow the instructions. 3. Participants who agree to participate in the study. 4. Control group where no retinal abnormalities were detected as part of the standard basic ophthalmic examination. 5. Participants with retinal disease in at least one eye including: Early dry age-related macular degeneration, late stage dry age-related macular degeneration specifically geographic atrophy, Wet age-related macular degeneration, Retinitis pigmentosa, Diabetic retinopathy and other macular atrophic diseases

Exclusion criteria

1. Inability to understand written and verbal English sufficiently to comprehend the study and provide informed consent 2. Ophthalmic disease other than condition under investigation. 3. Participants unable to tolerate ophthalmic imaging. 4. Cataract (unless deemed mild in the opinion of the investigator) 5. Participants with significant ocular media not sufficiently clear to obtain acceptable OCT images. 6. Diabetes (unless part of the diabetic eye disease group) 7. Binocular visual acuity worse than 6/18 8. Strabismus (squint) 9. Age related macular degeneration groups: polypoidal choroidal vasculopathy 10. Participants with photo sensitivity epilepsy, experience of seizures, or sensitivity to flickering light (based on self-report) 11. Pregnant

Design outcomes

Primary

MeasureTime frameDescription
OCT physical response data6 months from recruitment startResponse data per participant will be collected and analyzed

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026