Agreement of Two OCT Biometers: A Pilot Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorAlcon Research
About this trial
The purpose of this study is to compare the measurements obtained with two different biometers, UNITY Dx and Anterion. In eye care, a biometer is a device that uses laser technology to take highly precise measurements of the eye's internal structures. It is most frequently used to help determine the exact power of the intraocular lens (IOL) needed before cataract removal.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Have healthy, clear corneas for the normal cohort;
Have documented keratoconus for the keratoconus cohort;
Have reported use of daily contact lens use for the contact lens cohort;
Have documented dry eye, consisting of signs and symptoms for the dry eye cohort;
Disqualifiers
Active ocular infection or inflammation;
Unable to fixate due to nystagmus or other eye movement abnormality (e.g., significant strabismus);
Any ocular disease and/or condition that, in the investigator's clinical judgment, may put the subject at significant risk, may compromise study result or may interfere significantly with the subject's participation in the study.
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
50 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
Regression-Based Axial Length (R-AL)
Regression-based Axial Length (R-AL) is the distance from the anterior surface of the cornea to the retina at the back of the eye, measured along the visual axis. R-AL will be measured by the device and reported in microns.
Time frame
Day 1Sponsors and contacts
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Source ClinicalTrials.gov