Optical Biometer for Cataract

(CH-0203 Trial)

Overseen By Dr. Michael Petrik Petrik, OD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cassini Technologies

Disqualifiers: Inability to fixate, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new eye measurement device, the New Investigational Optical Biometer, to assist with cataract surgery. The device combines various technologies to provide accurate information about the eye's shape and structure, crucial for surgical planning. Individuals with cataracts, particularly those affecting vision, are needed to evaluate the device's effectiveness on cataract-affected eyes. Participants will have their eyes measured using this new device and two standard ones for comparison. Ideal candidates have cataracts in at least one eye and can focus on a target briefly. As an unphased trial, this study allows participants to contribute to innovative research that could enhance cataract surgery outcomes.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this optical biometer is safe for use in cataract patients?

Research has shown that the new eye measurement device, which uses advanced imaging technology, is undergoing safety testing. In another study, similar devices like the ARGOS Biometer were safely used in cataract surgery. These studies suggest that such devices are generally well-tolerated, with few reports of serious side effects.

The safety of the device is also being tested in both healthy eyes and those with cataracts using a similar, affordable device. This suggests that the new device should also be safe and cause minimal discomfort during use. While this specific device is still in development, past research generally considers the technology it uses to be safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the new investigational optical biometer because it offers a potentially more precise and efficient way to measure the eye's characteristics before cataract surgery. Unlike traditional methods, this optical biometer could streamline the diagnostic process by providing quick, accurate measurements that are crucial for planning cataract surgeries. By comparing it with existing devices, researchers hope to validate its effectiveness, potentially leading to better surgical outcomes and improved vision for patients.

What evidence suggests that this optical biometer is effective for cataract measurements?

Research shows that the Helioscope, a new eye measurement tool, might aid cataract surgery. It uses advanced light technology to quickly and accurately measure the eye's shape and size. One study found it was 100% successful in measuring an important eye dimension using similar technology. In this trial, all subjects will undergo ocular biometry with the investigational optical biometer, Comparator Device A, and Comparator Device B to compare diagnostic results. The Helioscope has also been compared to other devices and aims to provide reliable results even in eyes with dense cataracts. These early findings suggest it could be a promising tool for improving cataract surgery outcomes. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults over 21 years old with cataracts in at least one eye. Participants must be able to give written consent. It's designed to test a new device called the Helioscope on eyes affected by cataracts, which can impact vision and measurements needed for surgery.

Inclusion Criteria

I am at least 21 years old.

I have signed the consent form.

I have a cataract in at least one eye.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Measurement

Participants undergo ocular biometry using the investigational optical biometer and comparator devices for diagnostic comparison

1 visit

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after measurements

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• New Investigational Optical Biometer

Trial Overview

The study tests the Helioscope, a novel optical biometer combining LED-based corneal topography and SS-OCT technology, against two existing devices (Argos and Cassini Ambient). The goal is to ensure it provides accurate ocular measurements even in eyes with dense cataracts.

How Is the Trial Designed?

Group I: All enrolled subjects Experimental Treatment 3 Interventions

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.

Who Is Running the Clinical Trial?

Cassini Technologies

Lead Sponsor

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07325162

NCT07325162 | Development of Optical Biometer

Investigational optical biometer used to obtain axial length, keratometry, anterior chamber depth, lens thickness, and total corneal astigmatism ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11461292/

Axial length acquisition success rates and agreement of two ...

The axial length acquisition success rate was 100% (46 eyes) for both SS-OCT biometers. ERV mode of the Argos biometer were not used since all ...

3.

withpower.com

withpower.com/trial/phase-cataract-10-2025-b0bf9

Optical Biometer for Cataract (CH-0203 Trial)

The study tests the Helioscope, a novel optical biometer combining LED-based corneal topography and SS-OCT technology, against two existing ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07129980

Refractive and Visual Outcomes With the ARGOS Biometer ...

The study is to evaluate the visual and refractive outcomes in eyes with prior myopic refractive surgery undergoing cataract surgery for ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S0002939424003854

Introduction and Validation of Low-Cost Ocular Biometry

A novel substantially lower-priced and rapid swept-source investigational optical biometer in healthy and cataractous eyes, using a thermally tuned laser diode.

6.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf21/P210005B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)

The presence of capsular rupture or radial capsular tears known or suspected at the time of surgery. • Surgical difficulties at the time of cataract extraction, ...