Retinal Investigation Using Optos OCT Device

February 20, 2025 updated by: Optos, PLC

Clinical Investigation of Optos OCT in Patients with Retinal Pathologies

Retinal investigation using OCT with control and diseased eyes

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: standard imaging process
All participants will undergo the same imaging
Device: retinal functional imaging
this is a proof of concept study
Other Names:
  • OCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OCT physical response data
Time Frame: 6 months from recruitment start
Response data per participant will be collected and analyzed
6 months from recruitment start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Optos, PLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

February 13, 2025

First Submitted That Met QC Criteria

February 20, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 20, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPT1105
  • REC ref: 25/NS/0018 (Other Identifier: The North of Scotland Research Ethics Committee)
  • IRAS Project ID: 338297 (Other Identifier: Integrated Research Application System)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetic Retinopathy

Clinical Trials on retinal functional imaging

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe