Skip to main content
OpenTrials
Completed

NCT Number: NCT06826599

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Normal Eyes Abnormal Eyes

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NorthEast Eye Research Associates LLC

Woburn, Massachusetts, 01801, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

IOLMaster 700 Biometer

Device

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

Primary outcomes

  1. Central corneal thickness (CCT)

    Time frame: Day 1

    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.

  2. Lens thickness (LT)

    Time frame: Day 1

    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.

  3. Anterior chamber depth (regression) (ACD-R)

    Time frame: Day 1

    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.

  4. Axial length (regression) (AL-R)

    Time frame: Day 1

    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.

Secondary outcomes

  1. Anterior Chamber Depth Sum of Segments (ACD-SoS)

    Time frame: Day 1

    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.

  2. Axial Length Sum of Segments (AL-SoS)

    Time frame: Day 1

    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.

Sponsors and collaborators

Lead sponsor

Cylite Pty Ltd

Industry

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 14, 2025
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.