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

NCT06826599 | Completed FDA Device

• 1 other identifier: CYC-CL-SOP-004
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Normal Eyes; Abnormal Eyes

Keywords

Biometric measurements

Outcome Measures

Primary Outcomes (4)

• Central corneal thickness (CCT)

  Central corneal thickness will be measured in microns. This outcome measure will be analyzed using Bland-Altman Limits of Agreement, repeatability, reproducibility, and percent coefficient of variation (repeatability and reproducibility) methods.

  Day 1

• Lens thickness (LT)

  Lens thickness will be measured in microns and analyzed using Bland-Altman Limits of Agreement, repeatability, reproducibility, and percent coefficient of variation (repeatability and reproducibility) methods.

  Day 1

• Anterior chamber depth (regression) (ACD-R)

  Anterior chamber depth (the physical length from the anterior cornea to the anterior lens) will be measured in microns and analyzed using Bland-Altman Limits of Agreement, repeatability, reproducibility, and percent coefficient of variation (repeatability and reproducibility) methods.

  Day 1

• Axial length (regression) (AL-R)

  Axial length (the distance between the back and front of the eye) will be measured in millimeters and analyzed using Bland-Altman Limits of Agreement, repeatability, reproducibility, and percent coefficient of variation (repeatability and reproducibility) methods.

  Day 1

Secondary Outcomes (2)

• Anterior Chamber Depth Sum of Segments (ACD-SoS)

  Day 1

• Axial Length Sum of Segments (AL-SoS)

  Day 1

Study Arms (4)

Group 1 - Normal Eyes

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

Device: Investigational Biometer; Device: IOLMaster 700 Biometer

Group 2 - Eyes with cataracts

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

Device: Investigational Biometer; Device: IOLMaster 700 Biometer

Group 3 - Eyes with significant refractive errors

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

Device: Investigational Biometer; Device: IOLMaster 700 Biometer

Group 4 - Eyes with abnormal corneal topography

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

Device: Investigational Biometer; Device: IOLMaster 700 Biometer

Interventions

Investigational Biometer DEVICE

Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and measurement of anterior segment and biometric parameters

Group 1 - Normal Eyes; Group 2 - Eyes with cataracts; Group 3 - Eyes with significant refractive errors; Group 4 - Eyes with abnormal corneal topography

IOLMaster 700 Biometer DEVICE

Commercially available non-contact instrument used to capture optical biometry measurements

Group 1 - Normal Eyes; Group 2 - Eyes with cataracts; Group 3 - Eyes with significant refractive errors; Group 4 - Eyes with abnormal corneal topography

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cohorts will be selected from approximately one investigative site located in the United States.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cylite Pty Ltd: lead

Study Sites (1)

NorthEast Eye Research Associates LLC

Woburn, Massachusetts, 01801, United States

Location

Study Officials

• Arnold Ouyang, PhD

  Cylite Pty Ltd

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 14, 2025
• Study Start: January 18, 2025
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-08

Locations

US (1)