COMPLETED

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

Conditions

Normal Eyes Abnormal Eyes Biometric measurements

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-01-18

Study Completion:2025-03-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06826599

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.

Ages Eligible for Study:22 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Principal Investigator

Arnold Ouyang, PhD

STUDY_DIRECTOR

Cylite Pty Ltd

Study Locations (Sites)

NorthEast Eye Research Associates LLC

Woburn, Massachusetts, 01801

United States

Collaborators and Investigators

Sponsor: Cylite Pty Ltd

Arnold Ouyang, PhD, STUDY_DIRECTOR, Cylite Pty Ltd

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-18

Study Completion Date2025-03-30

Study Record Updates

Study Start Date2025-01-18

Study Completion Date2025-03-30

Terms related to this study

Keywords Provided by Researchers

Biometric measurements

Additional Relevant MeSH Terms

Normal Eyes
Abnormal Eyes