100 Participants Needed

Cassini Guidance for Cataract Surgery

(CG-Toric Trial)

DC
Overseen ByDr. Clayton Blehm Blehm, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Gainesville Eye Associates
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new digital system called Cassini Guidance, which assists doctors in aligning special lenses during cataract surgery. The goal is to determine if this technology increases surgical accuracy and improves vision by reducing astigmatism, a condition causing blurred vision due to an uneven eye shape. Individuals undergoing cataract surgery with toric lenses may be suitable candidates for this trial. The study focuses on surgeries without complications and will track results to ensure the system's effectiveness. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance surgical outcomes for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this digital guidance system is safe for cataract surgery?

Research has shown that the Cassini Guidance System is safe and effective for cataract surgeries. This system, which helps position toric intraocular lenses (IOLs), received FDA approval in 2014, confirming it meets safety standards for medical devices.

The Cassini Guidance System enhances the accuracy of placing toric IOLs during cataract surgery. Accurate placement is crucial because even a small misalignment can reduce the lens's effectiveness. The system eliminates the need for manual marking, streamlining the process and reducing the chance of errors.

Studies have demonstrated that the system creates a safe and efficient environment for cataract surgery. It is non-invasive, meaning it does not involve cutting into the body, which reduces the risk of complications.

Overall, the Cassini Guidance System is well-tolerated by patients and has not been associated with significant side effects. Its proven safety in surgeries makes it a reliable option for those considering participation in related trials.12345

Why are researchers excited about this trial?

Researchers are excited about the Cassini Guidance for cataract surgery because it offers a new way to improve the accuracy of intraoperative alignment for Toric intraocular lenses (IOLs). Unlike traditional methods, which rely heavily on manual alignment and can be prone to human error, Cassini Guidance uses advanced imaging technology to enhance precision. This could lead to better visual outcomes and fewer complications for patients undergoing cataract surgery, making it a promising advancement in eye care.

What evidence suggests that this digital guidance system is effective for cataract surgery?

Research has shown that the Cassini Guidance system, which participants in this trial will experience, improves the accuracy of toric lens placement during cataract surgery. This digital system reduces the need for manual marking, enhancing precision. Early results suggest it also helps surgeons save time during the procedure. Patients reported better vision, with less blurring caused by uneven eye shape after surgery. This leads to clearer vision and possibly less frequent need for glasses post-operation.12678

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?

1

Treatment groups

Experimental Treatment

Group I: Surgical guidance for Toric IOL alignment intraoperativelyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Gainesville Eye Associates

Lead Sponsor

Trials
7
Recruited
340+

Citations

NCT07325188 | HUD Surgical Guidance for Toric Alignment

Time efficiency (measured in seconds) of the Cassini Guidance System in eyes undergoing cataract surgery with toric IOL implantation.

2.

cassini-technologies.com

cassini-technologies.com/guidance

Cassini | Guidance

An inclusive, efficient cataract surgery solution that reduces manual marking, enhances accuracy and saves time. A bit of paragraph text for what guidance is.

Cassini Guidance in Cataract and IOL Surgery - ICH GCP

This study aims to assess the accuracy of toric intraocular lens (IOL) alignment axes as calculated and displayed by a novel digital ...

Cassini Technologies to present Latest Outcomes during ...

The Cassini Ambient aims to enhance the surgical experience and optimize outcomes for cataract surgery from pre-op diagnostics to post-op outcomes.

Cassini Guidance for Cataract Surgery (CG-Toric 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.

High-Tech Toric IOL Axis Alignment

“A 3-degree misalignment can lead to a 10 percent loss of cylinder correction,” said Kevin M. Miller, MD, at the University of California, Los ...

Cassini Ambient Brochure.pdf

Cassini Guidance System4 is a digital cataract surgery solution available to all patients – creating an inclusive, efficient and safe environment. This.

Intraoperative Guidance

The markerless version of the cataract suite, which received FDA 510(k) clearance in 2014, provides the benefit of accurate toric IOL alignment without needing ...