Agreement of Two OCT Biometers: A Pilot Study

Purpose

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.

Conditions

  • Anterior Segment of Eye
  • Axial Length
  • Biometrics Measurement

Eligibility

Eligible Ages
Over 21 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Normal Corneas This cohort will enroll subjects with normal corneas.
  • Device: UNITY DX
    Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
  • Device: ANTERION
    Commercially available non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
Keratoconus This cohort will enroll subjects with keratoconus.
  • Device: UNITY DX
    Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
  • Device: ANTERION
    Commercially available non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
Prior Corneal Laser Vision Correction This cohort will enroll subjects with prior corneal laser vision correction.
  • Device: UNITY DX
    Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
  • Device: ANTERION
    Commercially available non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
Current and Habitual Contact Lens Wear This cohort will enroll subjects with current and habitual contact lens wear.
  • Device: UNITY DX
    Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
  • Device: ANTERION
    Commercially available non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
Dry Eye This cohort will enroll subjects with dry eye.
  • Device: UNITY DX
    Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
  • Device: ANTERION
    Commercially available non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties

Recruiting Locations

The Eye Institute of Utah
Salt Lake City, Utah 84107

More Details

Status
Recruiting
Sponsor
Alcon Research

Study Contact

Alcon Call Center
1-888-451-3937
alcon.medinfo@alcon.com

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.