Cassini Guidance for Cataract Surgery

(CG-Toric Trial)

Overseen By Dr. Clayton Blehm Blehm, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Gainesville Eye Associates

Disqualifiers: Ocular comorbidity, Ocular trauma, Refractive surgery, Keratoconus, Disabilities, others

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

Compensation: Varies

Number of Visits: 2

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study aims to assess the accuracy of toric intraocular lens (IOL) alignment axes as calculated and displayed by a novel digital guidance system. In addition, it evaluates the time required to initiate surgical guidance and postoperative refractive astigmatism following toric IOL implantation.

This single-surgeon, single-site, prospective, non-invasive observational study evaluated the accuracy of toric IOL alignment axes calculated and displayed by the digital guidance system (Cassini Technologies, B.V.) in 100 eyes. The intraoperatively calculated alignment axes were compared to preoperative measurements to assess their accuracy (in degrees). Postoperative outcomes, including residual refractive astigmatism (diopters) and visual acuity (Snellen), were recorded at 1 month postoperatively.

Are You a Good Fit for This Trial?

This trial is for patients undergoing uncomplicated cataract surgery who will receive a toric intraocular lens (IOL) implant. It's not suitable for those with complications that might interfere with the surgery or the study.

Inclusion Criteria

I have a toric lens implant in my eye.

I am having cataract surgery with a toric lens implant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Guidance

Intraoperative guidance for toric IOL alignment using the Cassini Guidance System

Immediate (during surgery)

1 visit (in-person)

Postoperative Follow-up

Participants are monitored for residual refractive astigmatism and visual acuity

1 month

1 visit (in-person)

Extended Follow-up

Participants are monitored for long-term outcomes of toric IOL alignment

Up to 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Cassini Guidance

Trial Overview

The study tests a digital guidance system called Cassini Guidance to see how accurately it can align toric IOLs during cataract surgery, and measures any postoperative refractive astigmatism and visual acuity changes.

How Is the Trial Designed?

Group I: Surgical guidance for Toric IOL alignment intraoperatively Experimental Treatment 1 Intervention

Interventional

Who Is Running the Clinical Trial?

Gainesville Eye Associates

Lead Sponsor

Trials

7

Recruited

340+