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Clinical Trials/NCT05532410
NCT05532410CompletedNot Applicable

Optic Disc Photograph Collection Study

Optos, PLC1 site in 1 country121 target enrollmentStarted: September 2, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Optos, PLC
Enrollment
121
Locations
1
Primary Endpoint
Bland-Altman Plots of Stereo Disc Photos, SLO images and OCT Scans

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
22 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Subjects 22 years of age or older on the date of informed consent
  • •Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
  • •Subjects met inclusion/

Exclusion Criteria

  • •for the OPT1060 protocol
  • •Exclusion Criteria
  • •Subjects unable to tolerate ophthalmic imaging
  • •Subjects not able to obtain acceptable OCT, Stereo, or Optomap images due to ocular media opacity or other reasons

Arms & Interventions

Fundus Camera

Other

Intervention: Fundus Camera (Device)

Outcomes

Primary Outcomes

Bland-Altman Plots of Stereo Disc Photos, SLO images and OCT Scans

Time Frame: 1 year

Deming Regression of Stereo Disc Photos, SLO images and OCT Scans

Time Frame: 1 year

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Optos, PLC
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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