Development of Helioscope Optical Biometer for Cataract Surgery

This study is testing a new device called the Helioscope, which combines two technologies to measure your eye's shape and other important details. These measurements are crucial for planning cataract surgery and choosing the right intraocular lens (IOL). Researchers want to see how accurate the Helioscope is compared to two existing devices, Comparator Device A (Cassini Ambient) and Comparator Device B (Argos). You might be able to join if you are at least 21 years old, have cataracts in at least one eye, and can follow instructions. The main goal is to see if the Helioscope can accurately measure eye parameters in people with cataracts. The study's current status is unclear.

Study design
This interventional study plans to enroll 100 participants. It compares a new investigational device to two FDA-cleared devices.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your ocular parameters will be measured over the course of the study, which can last up to 12 months.

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NCT07325162

Development of Optical Biometer

Recruiting
NAAges 18+InterventionalDiagnostic
Cassini Technologies
~100 participants
Updated 2026-01-08 on ClinicalTrials.gov
What's tested:New Investigational Optical Biometer (Device)Comparator Device A (Cassini Ambient)omparator Device B (Argos)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Ocular parameters of cataractous eyes measured with a novel biometer
Measured over Overall study to complete up to 12 months
Cataract and IOL Surgery
1 sites across 1 states
South Carolina1

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Eligibility criteria

Inclusion

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

Exclusion

The inability to properly fixate on a fixation target for several seconds
The inability to provide informed consent.
  • Ocular parameters of cataractous eyes measured with a novel biometerOverall study to complete up to 12 months

    Primary endpoint: Biometric ocular parameters of axial length, anterior chamber depth, central corneal thickness, keratometry, lens thickness and limbal white to white will be measured by the Helioscope device in 200 eyes.