Optic Disc Photograph Collection Study

The objective of this study is to collect stereo-optic disc photographs for potential future analysis.

Study Overview

• Status: Completed
• Conditions: Glaucoma; Normal; Retina Disease
• Intervention / Treatment: Device: Fundus Camera

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60616
      • Illinois College of Optometry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria

1. Subjects 22 years of age or older on the date of informed consent
2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
3. Subjects met inclusion/exclusion criteria for the OPT1060 protocol

Exclusion Criteria

1. Subjects unable to tolerate ophthalmic imaging
2. Subjects not able to obtain acceptable OCT, Stereo, or Optomap images due to ocular media opacity or other reasons

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Fundus Camera	Device: Fundus Camera; The fundus camera is suitable for photographing, displaying and storing data relating to the retina and surrounding parts of the eye. These photographs assist with the diagnosis and follow-up of eye diseases, which can be visually monitored and photographically documented.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bland-Altman Plots of Stereo Disc Photos, SLO images and OCT Scans	1 year
Deming Regression of Stereo Disc Photos, SLO images and OCT Scans	1 year

Collaborators and Investigators

• Sponsor: Optos, PLC

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2022
• Primary Completion (Actual): March 21, 2023
• Study Completion (Actual): March 21, 2023

Study Registration Dates

• First Submitted: September 2, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (Actual): September 8, 2022

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: OPT1085

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes