Quatera 700 vs. Centurion for Cataract Surgery

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Carolina Eyecare Physicians, LLC

Must not be taking: Vision-interfering drugs

Disqualifiers: Severe ocular pathology, Uncontrolled diabetes, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Phacoemulsification is the most common treatment for cataract surgery in the developed countries and over the years it gained importance due to several factors: small incision, surgery performed under topical anesthesia - which reduce injection-related complications - short recovery time, low post operatory induced astigmatism, and low incidence of surgical complications, when compared to the conventional surgeries. The study evaluates 2 different phacoemulsification devices in patients undergoing routine cataract surgery in both eyes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use any drugs that interfere with visual performance during the study.

What data supports the effectiveness of the treatment Centurion Vision System for cataract surgery?

Research shows that the Centurion Vision System, used in cataract surgery, has been evaluated for its surgical and visual outcomes, and it features improvements like an active fluid dynamic management system and a balanced tip design, which may enhance surgical efficiency and safety.

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Is there any safety data available for the Centurion and Quatera 700 systems used in cataract surgery?

The available research does not provide specific safety data for the Centurion and Quatera 700 systems in cataract surgery.

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How does the Quatera 700 treatment for cataract surgery differ from other treatments?

The Quatera 700, also known as the Centurion Vision System, is unique because it features an active fluid dynamic management system and an intrepid balanced tip, which help maintain a stable eye environment during surgery. This system allows for lower intraocular pressure (pressure inside the eye) settings, potentially reducing damage to the cornea compared to traditional gravity-fed systems.

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Eligibility Criteria

This trial is for individuals who are scheduled to undergo routine cataract surgery in both eyes. Specific eligibility criteria details were not provided, so it's important to consult the study team for more information on who can participate.

Inclusion Criteria

I am between 50 and 80 years old.

I am set for cataract surgery in both eyes, with surgeries 1 to 30 days apart.

Subjects requiring an IOL power in the range of +10.0 D to +30.0 D only

Exclusion Criteria

I am having other eye procedures along with my cataract surgery.

I am not using any medication that affects my vision.

I have had radial keratotomy surgery.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo routine cataract surgery using either the Quatera 700 or Centurion Vision System

Intraoperative

Follow-up

Participants are monitored for safety and effectiveness after cataract surgery

4 weeks

Participant Groups

The study compares two different devices used in phacoemulsification, a common treatment for cataracts: Quatera 700 and Centurion. It aims to determine which device may be more effective or has advantages during routine cataract surgeries.

Group I: Quatera 700 Experimental Treatment 2 Interventions

Group II: Centurion Vision System Active Control 2 Interventions

Centurion is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Centurion Vision System for:

• Cataract surgery
• Anterior segment vitrectomy

🇪🇺 Approved in European Union as Centurion Vision System for:

• Cataract surgery
• Anterior segment vitrectomy

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Carolina Eyecare Physicians, LLC Mount Pleasant, SC

Who Is Running the Clinical Trial?

Carolina Eyecare Physicians, LLC Lead Sponsor

Science in Vision Collaborator

References

1. China pubmed.ncbi.nlm.nih.gov

Prospective study of Centurion® versus Infiniti® phacoemulsification systems: surgical and visual outcomes. [2020] Label="AIM" NlmCategory="OBJECTIVE">To evaluate surgical outcomes (SOs) and visual outcomes (VOs) in cataract surgery comparing the Centurion® phacoemulsification system (CPS) with the Infiniti® phacoemulsification system (IPS).

2. England pubmed.ncbi.nlm.nih.gov

Effect of IOP based infusion system with and without balanced phaco tip on cumulative dissipated energy and estimated fluid usage in comparison to gravity fed infusion in torsional phacoemulsification. [2022] To evaluate the effect of three different combinations of tip designs and infusion systems in torsional phacoemulsification (INFINITI and CENTURION) in patients with cataract. According to the manufacturer, two unique improvements in the Centurion are: active fluid dynamic management system and use of an intrepid balanced tip. The study specifically aimed to evaluate the beneficial effects, if any, of change in tip design and infusion system individually and in combination on both per-operative parameters as well as endothelial health over 6 months.

3. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison between bilateral implantation of a trifocal intraocular lens (Alcon Acrysof IQ® PanOptix) and extended depth of focus lens (Tecnis® Symfony® ZXR00 lens). [2021] To compare the visual performance outcomes following bilateral cataract surgery using trifocal intraocular lens (Alcon Acrysof IQ® PanOptix) and extended depth of focus lens (Tecnis® Symfony® ZXR00 lens).

4. United States pubmed.ncbi.nlm.nih.gov

Intraocular pressure study using monitored forced-infusion system phacoemulsification technology. [2022] To optimize phacoemulsification efficiency by varying the intraocular pressure (IOP) using the Centurion Vision System, a monitored forced-infusion system.

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Effect and Safety of Pressure Sensor-equipped Handpiece in Phacoemulsification System. [2023] To evaluate the effect of the Active Sentry handpiece of the Centurion Vision System compared to the Centurion Ozil handpiece for phacoemulsification in cataract surgery.

6. United States pubmed.ncbi.nlm.nih.gov

Comparison of two phacoemulsification system handpieces: prospective randomized comparative study. [2022] To compare the safety and efficacy of Active Sentry handpiece with Ozil handpiece for Centurion phacoemulsification system.

7. New Zealand pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety of the Clareon Monofocal Intraocular Lens: Outcomes from a 12-Month Single-Arm Clinical Study in a Large Sample. [2022] This study assessed effectiveness and safety of the novel Clareon intraocular lens (IOL; model SY60CL; Alcon Vision LLC).

8. Spain pubmed.ncbi.nlm.nih.gov

[Intraocular lenses with blue light filter]. [2019] To evaluate if a SN60AT > IOL (Alcon) with IMPRUV filter (Alcon) offers any advantage in patients having cataract surgery, as compared with Acrysof SA60 IOL (Alcon).

9. United States pubmed.ncbi.nlm.nih.gov

Cataract surgery using the bimanual phacoemulsification technique with an Accurus system and Mackool microphaco tip. [2007] To investigate the safety and effectiveness of the Accurus vitreoretinal and phacoemulsification system (Alcon, Inc.) for bimanual phacoemulsification surgery.

10. United States pubmed.ncbi.nlm.nih.gov

Quality of vision after bilateral multifocal intraocular lens implantation: a randomized trial--AT LISA 809M versus AcrySof ReSTOR SN6AD1. [2022] To compare postoperative visual symptoms and spectacle freedom after bilateral implantation of the AT LISA 809M (Carl Zeiss Meditec, Jena, Germany) versus the AcrySof ReSTOR SN6AD1 (Alcon Laboratories, Irvine, CA) multifocal intraocular lens (IOL).

11. Switzerland pubmed.ncbi.nlm.nih.gov

Comparisons of the clinical outcomes of Centurion® active fluidics system with a low IOP setting and gravity fluidics system with a normal IOP setting for cataract patients with low corneal endothelial cell density. [2023] During cataract phacoemulsification surgery, the Alcon Centurion with Active Sentry can achieve a more stable anterior chamber, which allows a lower intraocular pressure (IOP) setting than the gravity fluidics system. In this randomized controlled trial, we compared these two systems' damage to the cornea under different IOP settings.