Agreement and Precision Study | NCT06733428

Studies
Agreement and Precision Study

NCT06733428

Sponsor

Topcon Corporation

Status

Completed

Last Update Posted

Feb 4, 2025Actual

Enrollment

108Actual

Phase

Not provided

Conditions

Eye Abnormalities
Normal Eyes

Interventions

Pachymeter

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

Jan 2025

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

Jan 9, 2025Actual

Primary Completion Date

Jan 28, 2025Actual

Completion Date

Jan 28, 2025Actual

First Submitted Date

Dec 10, 2024

First Submission Date that Met QC Criteria

Dec 10, 2024

First Posted Date

Dec 13, 2024Actual

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

Jan 31, 2025

Last Update Posted Date

Feb 4, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

108Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Normal	Subjects with healthy cornea	Device: Pachymeter
Cornea	Subjects with abnormal cornea	Device: Pachymeter
Glaucoma	Subjects with glaucoma	Device: Pachymeter

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pachymeter	Device	Measure the thickness of the cornea	Cornea Glaucoma Normal

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cornea thickness	thickness of the cornea	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Provide voluntary written consent
Age at least 22 years old
For glaucoma group only, visual field defect and optic nerve damage consistent with glaucoma
For cornea group only, cornea abnormality

Exclusion Criteria:

Ocular condition that may affect ability to perform cornea measurements
Have or is suspected to have ocular infection
Unable to tolerate eye testing

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

Subjects seeing an eye doctor that have normal cornea, cornea abnormality, or glaucoma

Sampling Method

Non-Probability Sample

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
D005124	Eye Abnormalities

Ancestor Terms

ID	Term
D005128	Eye Diseases
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided