Print

Purpose

The Helioscope (Cassini Technologies B.V.) is a novel device under development that aims at combining LED-based corneal topography and SS-OCT to provide accurate and fast measurements of both the corneal shape and the ocular biometry. To that end, the hardware and software of the Cassini color-LED topographer (Cassini Technologies B.V.) is combined with a novel SS-OCT device. While the new Helioscope can largely be evaluated using data acquired with healthy eyes, one of its main use-cases is providing input for IOL power formulae for cataract surgery. Thus, it is essential that the device can perform measurements in eyes with (dense) cataract. As cataract changes the optical properties of the crystalline lens and the OCT measurement is optical, this is not a given. This study therefore seeks a dataset of Helioscope measurements performed in eyes with cataract that can be used to develop the software algorithms of the Helioscope.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • The presence of cataract in at least one eye. - Minimally 21 years of age. - Provided written informed consent.

Exclusion Criteria

  • The inability to properly fixate on a fixation target for several seconds - The inability to provide informed consent.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
All enrolled subjects 		All eligible subjects will undergo ocular biometry using three devices: 1. the investigational optical biometer, 2. Comparator Device A, and 3. Comparator Device B. Measurements from all devices will be obtained at the same visit and used only for diagnostic comparison. No treatment assignment occurs.
  • Device: New Investigational Optical Biometer (Device)
    Investigational optical biometer used to obtain axial length, keratometry, anterior chamber depth, lens thickness, and total corneal astigmatism. Device is being evaluated for measurement accuracy and agreement.
  • Device: Comparator Device A (Cassini Ambient)
    FDA-cleared corneal topographer used as a reference standard comparator for keratometry.
  • Device: omparator Device B (Argos)
    FDA-cleared optical biometer used as a second comparator to assess agreement and measurement differences.

Recruiting Locations

Bishop Eye Center
Hilton Head Island 4581832, South Carolina 4597040 29926
Contact:
Paul Bell Bell, MD
843-689-3937
paulmbell@gmail.com

More Details

Status
Recruiting
Sponsor
Cassini Technologies

Study Contact

Dr. Michael Petrik Petrik, OD
236-982-8672
m.petrik@cassini-technologies.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.