iCare IC1000 Alignment Study

August 7, 2025 updated by: Icare Finland Oy
The primary objective of this study is to evaluate the performance of the alignment feature of iCare IC1000 tonometer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Lake Worth, Florida, United States, 33467
        • Clear Vue Laser Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

1. Age ≥ 18 years

Exclusion Criteria:

  1. Subjects with only one functional eye
  2. Central corneal scarring
  3. Microphthalmos
  4. Buphthalmos
  5. Contact lens use during measurement or hard lenses 24h prior to measurement
  6. Dry eyes (clinically significant)
  7. Nystagmus
  8. Keratoconus
  9. Any other corneal or conjunctival pathology or infection relevant to this study
  10. Coloboma or other pupil deformation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Measurement of IOP Values
Device: iCare IC1000 measurement
Measurement of intraocular pressure with iCare IC1000

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Objective
Time Frame: Through study completion, an average of 2 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icare Finland Oy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2025

Primary Completion (Actual)

August 5, 2025

Study Completion (Actual)

August 5, 2025

Study Registration Dates

First Submitted

May 22, 2025

First Submitted That Met QC Criteria

June 13, 2025

First Posted (Actual)

June 15, 2025

Study Record Updates

Last Update Posted (Actual)

August 12, 2025

Last Update Submitted That Met QC Criteria

August 7, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • TA032-168

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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