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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Normal Eyes
Intervention / Treatment

-

Contacts and Locations

Woburn

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

22 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Cylite Pty Ltd,

Arnold Ouyang, PhD, STUDY_DIRECTOR, Cylite Pty Ltd

Study Record Dates

2025-03-30