Anterior Segment of Eye, Axial Length, Biometrics Measurement
Conditions
Keywords
Biometer
Brief summary
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.
Detailed description
The study population will consist of male and female adult subjects with a normal cornea (up to 10 subjects), keratoconus (up to 10 subjects), prior corneal laser vision correction (up to 10 subjects), current and habitual contact lens wear (up to 10 subjects), or dry eye (up to 10 subjects). In this single visit study, subjects will have data collected on one eye (unilateral) only. If both eyes meet the entry criteria, the right eye will be designated as the study eye.
Interventions
DEVICEUNITY DX
Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
DEVICEANTERION
Commercially available non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
Sponsors
Alcon Research
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Inclusion criteria
* 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; * Has had previous keratorefractive surgery for the post-refractive surgery cohort; * Able to comprehend and sign the informed consent form.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Regression-Based Axial Length (R-AL) | Day 1 | 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. |
Countries
United States
Contacts
CONTACTAlcon Call Center
STUDY_DIRECTORClinical Trial Lead, Surgical
Alcon Research, LLC
Outcome results
None listed