NCT07629232

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

May 27, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Completed
Last Updated

June 5, 2026

Status Verified

June 1, 2026

Enrollment Period

2 months

First QC Date

May 22, 2026

Last Update Submit

June 1, 2026

Conditions

Corneal Parameters

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

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

Interventions

Investigational deviceDEVICE

Measurement of corneal parameters

Measurement with the investigational device
Comparator deviceDEVICE

Measurement of corneal parameters

Measurement with Heidelberg AnterionMeasurement with Nidek NT-530PMeasurement with Zeiss IOL Master 700

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitäts-Augenklinik Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

Location

Central Study Contacts

Maximilian Pfau, Prof.

CONTACT

+4915164672802Maximilian.Pfau@ukbonn.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2026

First Posted

June 5, 2026

Study Start

May 27, 2026

Primary Completion

July 31, 2026

Study Completion

July 31, 2026

Last Updated

June 5, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)