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NCT05532410 Clinical Trial

Optic Disc Photograph Collection Study

Glaucoma Clinical Trial

Official title:
Optic Disc Photograph Collection Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05532410
Other study ID # OPT1085
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2, 2022
Est. completion date March 21, 2023

Study information
Verified date December 2023
Source Optos, PLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 121
Est. completion date March 21, 2023
Est. primary completion date March 21, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 22 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Illinois College of Optometry Chicago Illinois

Sponsors (1)
Lead Sponsor Collaborator
Optos, PLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bland-Altman Plots of Stereo Disc Photos, SLO images and OCT Scans 1 year
Primary Deming Regression of Stereo Disc Photos, SLO images and OCT Scans 1 year
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