NCT04083742

Brief Summary

This is a prospective clinical study that will be conducted at one clinical site located in the United States to assess anterior segment metrics with the ANTERION

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2019

Longer than P75 for all trials

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

Study Start

First participant enrolled

August 22, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 23, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 10, 2019

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

June 21, 2024

Status Verified

June 1, 2024

Enrollment Period

4.2 years

First QC Date

August 23, 2019

Last Update Submit

June 18, 2024

Conditions

Narrow AngleOpen Angle

Outcome Measures

Primary Outcomes (12)

  • Repeatability and Reproducibility 1

    Reproducibility and repeatability of Spur to Spur distance parameter \[mm\] of ANTERION and the reference device

    1 day

  • Repeatability and Reproducibility 2

    Reproducibility and repeatability of Angle to Angle distance parameter \[mm\] of ANTERION and the reference device

    1 day

  • Repeatability and Reproducibility 3

    Reproducibility and repeatability of Lens Vault parameter \[µm\] of ANTERION and the reference device

    1 day

  • Repeatability and Reproducibility 4

    Reproducibility and repeatability of Anterior Segment Angles parameter \[°\] of ANTERION and the reference device

    1 day

  • Repeatability and Reproducibility 5

    Reproducibility and repeatability of TISA parameters \[mm2\] of ANTERION and the reference device

    1 day

  • Repeatability and Reproducibility 6

    Reproducibility and repeatability of AOD parameters \[µm\] of ANTERION and the reference device

    1 day

  • Agreement 1

    Agreement of Spur to Spur distance parameter \[mm\] between the ANTERION and the reference device

    1 day

  • Agreement 2

    Agreement of Angle to Angle distance parameter \[mm\] between the ANTERION and the reference device

    1 day

  • Agreement 3

    Agreement of Lens Vault parameter \[µm\] between the ANTERION and the reference device

    1 day

  • Agreement 4

    Agreement of Anterior Segment Angles parameter \[°\] between the ANTERION and the reference device

    1 day

  • Agreement 5

    Agreement of TISA parameters \[mm2\] between the ANTERION and the reference device

    1 day

  • Agreement 6

    Agreement of AOD parameters \[µm\] between the ANTERION and the reference device

    1 day

Secondary Outcomes (1)

  • Adverse Events Rate

    1 day

Study Arms (2)

Eyes with Open Angle

3 repeat measurements on each of the 3 investigational and reference devices

Device: ANTERION

Eyes with Narrow Angle

3 repeat measurements on each of the 3 investigational and reference devices

Device: ANTERION

Interventions

ANTERIONDEVICE

3 repeat angle measurements performed on each of the 3 Anterion devices and the 3 reference devices

Eyes with Narrow AngleEyes with Open Angle

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Eyes with narrow angle and eyes with open angle

You may qualify if:

  • Age 22 years or older
  • Able and willing to undergo the test procedures, sign informed consent, and follow instructions
  • Able to fixate
  • With at least one of following eye status for the corresponding eye population:
  • A. Eye with Open Angle (defined by Spaeth gonioscopy grading)
  • B. Eye with Narrow Angle (defined by Spaeth gonioscopy grading)

You may not qualify if:

  • Subjects which were enrolled in the B-2018-1 study
  • Active infection or inflammation in either eye
  • Insufficient tear film or corneal reflex
  • Physical inability to be properly positioned at the study devices or eye exam equipment
  • Rigid contact lens wear during 2 weeks prior to day when study device acquisitions take place
  • Soft lenses worn within one hour prior to study device acquisitions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State University of New York College of Optometry

New York, New York, 10036, United States

Location

Study Officials

  • Mitchell Dul

    State University of New York College of Optometry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2019

First Posted

September 10, 2019

Study Start

August 22, 2019

Primary Completion

November 15, 2023

Study Completion

December 31, 2023

Last Updated

June 21, 2024

Record last verified: 2024-06

Locations

US(1)