Not yet recruiting NCT07629232
Measuring Corneal Parameters
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Investigational device, Comparator device.
- Who it may be relevant to
- Registry conditions: Corneal Parameters. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Feasibility Study - Measuring Corneal Parameters
Overview
The aim of this clinical investigation is to assess the feasibility of the investigational device for measuring corneal parameters of the human eye.
Interventions
- Device Investigational device
Measurement of corneal parameters - Device Comparator device
Measurement of corneal parameters
Primary outcome measures
- 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]
Eligibility criteria
Inclusion criteria
1\. Age ≥ 18 years
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
Germany · 1 center
- Universitäts-Augenklinik Bonn — Bonn
Identifiers
NCT: NCT07629232 · TA05-001