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Development of a Next-Generation Optical Biometer for Eyes With Cataract

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• The presence of cataract in at least one eye.

• Minimally 21 years of age.

• Provided written informed consent.

Locations
United States
South Carolina
Bishop Eye Center
RECRUITING
Hilton Head Island
Contact Information
Primary
Dr. Michael Petrik Petrik, OD
m.petrik@cassini-technologies.com
236-982-8672
Time Frame
Start Date: 2025-11-07
Estimated Completion Date: 2026-03-30
Participants
Target number of participants: 100
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Cassini Technologies

This content was sourced from clinicaltrials.gov