Measuring Corneal Parameters

NCT07629232 — Not applicable, Completed, 50 participants, Icare Finland Oy

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Feasibility Study - Measuring Corneal Parameters

Registry	NCT07629232
Status	Completed
Phase	Not applicable
Study type	Interventional; non randomized, sequential, masking: none, device feasibility
Enrollment	50 (Actual)
Sponsor	Icare Finland Oy (Industry)
Conditions	Corneal Parameters
Interventions	Investigational device, Comparator device (Device)
Dates	start 2026-06-01, primary completion 2026-09-30, completion 2026-09-30, first posted 2026-06-05, last updated 2026-10-20
Locations	1 site in Germany

-Summary

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

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+Arms and interventions

Arm	Type	Interventions
Measurement with the investigational device	Experimental	Device: Investigational device
Measurement with Zeiss IOL Master 700	Experimental	Device: Comparator device
Measurement with Heidelberg Anterion	Experimental	Device: Comparator device
Measurement with Nidek NT-530P	Experimental	Device: Comparator device

Investigational device (Device): Measurement of corneal parameters
Comparator device (Device): Measurement of corneal parameters

+Outcome measures

Primary outcomes

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. [Through study completion, an average of 2 months]

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Universitäts-Augenklinik Bonn	Bonn, North Rhine-Westphalia	Germany