Agreement and Precision Study of UNITY® DX and a Comparator Biometer

Cylite Pty Ltd

Status: Completed

Conditions: Normal Eyes; Abnormal Eyes

Treatments: Device: Investigational Biometer; Device: IOLMaster 700 Biometer

Study type: Observational

Funder types: Industry

Identifiers

NCT06826599

CYC-CL-SOP-004

Details and patient eligibility

About

The purpose of this study is to validate the clinical measurement performance of an investigational biometer. Subjects will undergo multiple measurements of the eye, and the agreement, repeatability, and reproducibility of the biometric measurements will be evaluated.

Full description

This is intended to be a 1-visit study approximately 3 hours in length with planned duration of exposure of up to 20 minutes per device (investigational biometer and IOLMaster 700). Four cohorts will be enrolled. One eye per subject will be assessed.

Enrollment: 160 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Able to understand and sign an Institution Review Board approved Informed Consent form.
• Willing and able to attend all scheduled study visits as required by the protocol.
• Identified by the investigator as eligible for at least one of the 4 eye groups identified in the protocol.

Exclusion criteria

• Unable to fixate, for example, due to nystagmus or other eye movement abnormality.
• Any ocular disease and/or condition that, in the investigator's clinical judgment, may put the subject at significant risk, may compromise study results, or may interfere significantly with the subject's participation in the study.
• Active ocular infection or inflammation.
• Rigid or contact lens wear during the previous two weeks prior to Screening.

Trial design

160 participants in 4 patient groups

Group 1 - Normal Eyes

Description:

The eye will be imaged up to seven times with the biometer to achieve three acceptable scans

Treatment:

Device: IOLMaster 700 Biometer

Device: Investigational Biometer

Group 2 - Eyes with cataracts

Description:

The eye will be imaged up to seven times with the biometer to achieve three acceptable scans

Treatment:

Device: IOLMaster 700 Biometer

Device: Investigational Biometer

Group 3 - Eyes with significant refractive errors

Description:

The eye will be imaged up to seven times with the biometer to achieve three acceptable scans

Treatment:

Device: IOLMaster 700 Biometer

Device: Investigational Biometer

Group 4 - Eyes with abnormal corneal topography

Description:

The eye will be imaged up to seven times with the biometer to achieve three acceptable scans

Treatment:

Device: IOLMaster 700 Biometer

Device: Investigational Biometer