NCT05532410

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

September 2, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 8, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2023

Completed
Last Updated

December 7, 2023

Status Verified

December 1, 2023

Enrollment Period

7 months

First QC Date

September 2, 2022

Last Update Submit

December 6, 2023

Conditions

Retina DiseaseGlaucomaNormal

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Fundus Camera

OTHER
Device: Fundus Camera

Interventions

Fundus CameraDEVICE

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.

Fundus Camera

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Illinois College of Optometry

Chicago, Illinois, 60616, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2022

First Posted

September 8, 2022

Study Start

September 2, 2022

Primary Completion

March 21, 2023

Study Completion

March 21, 2023

Last Updated

December 7, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)