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

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.

Study Overview

• Status: Completed
• Conditions: Normal Eyes; Abnormal Eyes
• Intervention / Treatment: Device: Investigational Biometer; Device: IOLMaster 700 Biometer

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 160

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Woburn, Massachusetts, United States, 01801
      • NorthEast Eye Research Associates LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1 - Normal Eyes; The eye will be imaged up to seven times with the biometer to achieve three acceptable scans	Device: Investigational Biometer; Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and measurement of anterior segment and biometric parameters; Device: IOLMaster 700 Biometer; Commercially available non-contact instrument used to capture optical biometry measurements
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; Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and measurement of anterior segment and biometric parameters; Device: IOLMaster 700 Biometer; Commercially available non-contact instrument used to capture optical biometry measurements
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; Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and measurement of anterior segment and biometric parameters; Device: IOLMaster 700 Biometer; Commercially available non-contact instrument used to capture optical biometry measurements
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; Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and measurement of anterior segment and biometric parameters; Device: IOLMaster 700 Biometer; Commercially available non-contact instrument used to capture optical biometry measurements

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anterior Chamber Depth Sum of Segments (ACD-SoS)	ACD-SoS is calculated by calculating the individual corneal thickness and aqueous depth segments, applying the known refractive indices for each segment, and summing the resultant measurement of each segment. ACD-SoS will be measured in microns and analyzed using Bland-Altman Limits of Agreement, repeatability, and reproducibility methods.	Day 1
Axial Length Sum of Segments (AL-SoS)	AL-SoS is calculated by calculating the individual corneal thickness, aqueous depth, lens thickness and vitreous length segments, applying the known refractive indices for each segment, and summing the resultant measurement of each segment. AL-SoS will be measured in millimeters and analyzed using using Bland-Altman Limits of Agreement, repeatability, and reproducibility methods.	Day 1

Collaborators and Investigators

• Sponsor: Cylite Pty Ltd
• Investigators: Study Director: Arnold Ouyang, PhD, Cylite Pty Ltd

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2025
• Primary Completion (Actual): March 30, 2025
• Study Completion (Actual): March 30, 2025

Study Registration Dates

• First Submitted: February 4, 2025
• First Submitted That Met QC Criteria: February 12, 2025
• First Posted (Actual): February 14, 2025

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Biometric measurements
• Other Study ID Numbers: CYC-CL-SOP-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No