Retinal Investigation Using Optos OCT Device

NCT ID: NCT06846151

Last Updated: 2025-02-25

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-31

Study Completion Date

2026-01-31

Brief Summary

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Retinal investigation using OCT with control and diseased eyes

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

all participants receive a single intervention at a single point in time
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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standard imaging process

All participants will undergo the same imaging

Group Type OTHER

retinal functional imaging

Intervention Type DEVICE

this is a proof of concept study

Interventions

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retinal functional imaging

this is a proof of concept study

Intervention Type DEVICE

Other Intervention Names

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OCT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Optos, PLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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REC ref: 25/NS/0018

Identifier Type: OTHER

Identifier Source: secondary_id

IRAS Project ID: 338297

Identifier Type: OTHER

Identifier Source: secondary_id

OPT1105

Identifier Type: -

Identifier Source: org_study_id

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