Retinal Investigation Using Optos OCT Device

NCT06846151 | Not Yet Recruiting

• 3 other identifiers: OPT1105REC ref: 25/NS/0018IRAS Project ID: 338297
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

Retinal investigation using OCT with control and diseased eyes

Conditions

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

Outcome Measures

Primary Outcomes (1)

• OCT physical response data

  Response data per participant will be collected and analyzed

  6 months from recruitment start

Study Arms (1)

standard imaging process

OTHER

All participants will undergo the same imaging

Device: retinal functional imaging

Interventions

retinal functional imaging DEVICE

this is a proof of concept study

Also known as: OCT

standard imaging process

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Participants who understand the study and patient information sheet and can follow the instructions.
• Participants who agree to participate in the study.
• Control group where no retinal abnormalities were detected as part of the standard basic ophthalmic examination.
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Optos, PLC: lead

MeSH Terms

Conditions

Macular Degeneration; Retinitis Pigmentosa; Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Eye Diseases, Hereditary; Retinal Dystrophies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: all participants receive a single intervention at a single point in time

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 25, 2025
• Study Start: May 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: January 1, 2026
• Last Updated: February 25, 2025

Record last verified: 2025-02