Optic Disc Photograph Collection Study | NCT05532410

Studies
Optic Disc Photograph Collection Study

NCT05532410

Sponsor

Optos, PLC

Status

Completed

Last Update Posted

Dec 7, 2023Actual

Enrollment

121Actual

Phase

Not Applicable

Conditions

Retina Disease
Glaucoma
Normal

Interventions

Fundus Camera

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2, 2022Actual

Primary Completion Date

Mar 21, 2023Actual

Completion Date

Mar 21, 2023Actual

First Submitted Date

Sep 2, 2022

First Submission Date that Met QC Criteria

Sep 6, 2022

First Posted Date

Sep 8, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 6, 2023

Last Update Posted Date

Dec 7, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

121Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fundus Camera	Other		Device: Fundus Camera

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fundus Camera	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Illinois College of Optometry		Chicago	Illinois	60616	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005901	Glaucoma

Ancestor Terms

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided