Retinal Investigation Using Optos OCT Device | NCT06846151 | Trialant
Not yet recruitingInterventionalNot ApplicableUpdated Feb 25, 2025
Retinal Investigation Using Optos OCT Device
Clinical Investigation of Optos OCT in Patients with Retinal Pathologies
ClinicalTrials.gov ID
NCT06846151
Lead Sponsor
Optos, PLCINDUSTRY
Overall Status
Not yet recruiting
Study Type
Interventional
Phase
Not Applicable
Enrollment
120Estimated
Last Update Posted
Feb 25, 2025Actual
Start Date
May 2025Estimated
Primary Completion Date
Nov 2025Estimated
Completion Date
Jan 2026Estimated
Official Title
Clinical Investigation of Optos OCT in Patients with Retinal Pathologies
Brief Summary
Retinal investigation using OCT with control and diseased eyes
AMD - Age-Related Macular Degeneration
Retinitis Pigmentosa (RP)
Diabetic Retinopathy
Control Patients
retinal functional imaging
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)