Retinal Investigation Using Optos OCT Device

Optos

Status: Not yet enrolling

Conditions: AMD - Age-Related Macular Degeneration; Control Patients; Diabetic Retinopathy; Retinitis Pigmentosa (RP)

Treatments: Device: retinal functional imaging

Study type: Interventional

Funder types: Industry

Identifiers

NCT06846151

IRAS Project ID: 338297 (Other Identifier)

REC ref: 25/NS/0018 (Other Identifier)

OPT1105

Details and patient eligibility

About

Retinal investigation using OCT with control and diseased eyes

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

standard imaging process

Other group

Description:

All participants will undergo the same imaging

Treatment:

Device: retinal functional imaging