NCT07022054

Brief Summary

The primary objective of this study is to evaluate the performance of the alignment feature of iCare IC1000 tonometer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

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

May 22, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

May 22, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 15, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2025

Completed
Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

May 22, 2025

Last Update Submit

August 7, 2025

Conditions

Intraocular Pressure

Outcome Measures

Primary Outcomes (1)

  • Primary Objective

    Number of participants with successful intraocular pressure (IOP) measurements using the alignment feature of the iCare IC1000 tonometer during a single clinic visit.

    Through study completion, an average of 2 months

Study Arms (1)

Measurement of IOP Values

EXPERIMENTAL
Device: iCare IC1000 measurement

Interventions

iCare IC1000 measurementDEVICE

Measurement of intraocular pressure with iCare IC1000

Measurement of IOP Values

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Age ≥ 18 years

You may not qualify if:

  • Subjects with only one functional eye
  • Central corneal scarring
  • Microphthalmos
  • Buphthalmos
  • Contact lens use during measurement or hard lenses 24h prior to measurement
  • Dry eyes (clinically significant)
  • Nystagmus
  • Keratoconus
  • Any other corneal or conjunctival pathology or infection relevant to this study
  • Coloboma or other pupil deformation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clear Vue Laser Eye Center

Lake Worth, Florida, 33467, United States

Location

Study Design

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

Study Record Dates

First Submitted

May 22, 2025

First Posted

June 15, 2025

Study Start

May 22, 2025

Primary Completion

August 5, 2025

Study Completion

August 5, 2025

Last Updated

August 12, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)