Helioscope optical biometer combining LED corneal topography and SS-OCT
Development of a Next-Generation Optical Biometer for Eyes With Cataract
NA · Cassini Technologies · NCT07325162
This study will test whether the Helioscope can take accurate corneal shape and eye-length measurements in adults with cataracts to help choose the right intraocular lens power.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cassini Technologies (industry) |
| Locations | 1 site (Hilton Head Island, South Carolina) |
| Trial ID | NCT07325162 on ClinicalTrials.gov |
What this trial studies
The Helioscope combines a color LED–based corneal topographer with a novel swept‑source OCT (SS‑OCT) module to capture corneal shape and ocular biometry in a single device. The study collects Helioscope measurements in adults with cataract and compares them to readings from the Cassini Ambient topographer and the Argos SS‑OCT biometer. Data from cataractous eyes will be used to develop and refine the device’s software algorithms, with special attention to performance in dense cataract. Measurements are acquired at a single clinical site after informed consent and with eligibility limited to adults who can fixate.
Who should consider this trial
Good fit: Adults aged 21 or older with cataract in at least one eye who can fixate and provide informed consent are appropriate candidates.
Not a fit: Patients who cannot reliably fixate, cannot provide informed consent, or whose media opacities prevent OCT imaging are unlikely to receive benefit from this device.
Why it matters
Potential benefit: If successful, the Helioscope could provide faster, more complete biometry including corneal topography in cataract patients, improving intraocular lens power selection and refractive outcomes.
How similar studies have performed: Other swept‑source OCT biometers (for example Argos and IOLMaster 700) have shown reliable biometry performance, but combining LED color‑topography with SS‑OCT in one device is a newer approach still under development.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hilton Head Island, South Carolina
- Bishop Eye Center — Hilton Head Island, South Carolina, United States (RECRUITING)
Study contacts
- Study coordinator: Dr. Michael Petrik Petrik, OD
- Email: m.petrik@cassini-technologies.com
- Phone: 236-982-8672
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cataract and IOL Surgery, Optical Biometer, SS-OCT