UNITY DX Cornea Study
ConditionTomography
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsorAlcon Research
About this trial
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 corneal and epithelial thickness maps will be evaluated.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Able to understand and sign an Institutional Review Board approved informed consent form.
Willing and able to attend all scheduled study visits as required per protocol.
Identified by the investigator as having normal corneas or abnormal corneas per protocol-specified criteria.
Other protocol-specified inclusion criteria may apply.
Disqualifiers
Unable to fixate due to nystagmus or other eye movement abnormality, such as significant strabismus.
Any ocular disease and/or condition that, in the investigator's clinical judgement, 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.
Other protocol-specified exclusion criteria may apply.
Trial population
Cohorts will be selected from approximately one investigative site located in the United States.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
UNITY DX
DeviceInvestigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
ANTERION
DeviceCommercially available non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
Treatment groups
110 Participants
are divided into 5 treatment groupsGroup A: Normal Corneas2 interventions
Group B: Keratoconus2 interventions
Group C: Prior Corneal Laser Vision Correction2 interventions
Group D: Current and Habitual Contact Lens Wear2 interventions
Group E: Dry Eye2 interventions
Trial outcomes
Primary outcomes
1
Mean corneal thickness
Corneal thickness will be measured by the device and reported in microns. This outcome measure will be analyzed using Bland-Altman Limits of Agreement, Deming regression, repeatability and reproducibility.
Time frame
Day 12
Mean epithelial thickness
Epithelial thickness will be measured by the device and reported in microns. This outcome measure will be analyzed using Bland-Altman Limits of Agreement, Deming regression, repeatability and reproducibility.
Time frame
Day 1Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov