Measuring Corneal Parameters

June 1, 2026 updated by: Icare Finland Oy

Feasibility Study - Measuring Corneal Parameters

The aim of this clinical investigation is to assess the feasibility of the investigational device for measuring corneal parameters of the human eye.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

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 Contact

Study Locations

  • Germany
    • North Rhine-Westphalia
      • Bonn, North Rhine-Westphalia, Germany, 53127
        • Universitäts-Augenklinik Bonn
        • Contact:

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. Subjects having poor or eccentric fixation in the study eye(s)
  3. Central corneal scarring (that might affect the measurement result)
  4. Microphthalmos
  5. Buphthalmos
  6. Contact lens use (12 hours prior to measurements)
  7. Severe dry eyes
  8. Lid squeezers - blepharospasm
  9. Nystagmus
  10. Any other corneal or conjunctival pathology or condition that prevents CCT measurements

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: Device Feasibility
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Measurement with the investigational device
Device: Investigational device
Measurement of corneal parameters
Experimental: Measurement with Zeiss IOL Master 700
Device: Comparator device
Measurement of corneal parameters
Experimental: Measurement with Heidelberg Anterion
Device: Comparator device
Measurement of corneal parameters
Experimental: Measurement with Nidek NT-530P
Device: Comparator device
Measurement of corneal parameters

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary objective of this study is to collect a comprehensive dataset of central corneal thickness (CCT) values to assess the performance of investigational device.
Time Frame: Through study completion, an average of 2 months
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 (Estimated)

May 27, 2026

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

May 22, 2026

First Submitted That Met QC Criteria

June 1, 2026

First Posted (Actual)

June 5, 2026

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • TA05-001

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

No

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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