Quatera 700 vs. Centurion for Cataract Surgery

Not currently recruiting at 1 trial location

Overseen By Helga P. Sandoval

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Carolina Eyecare Physicians, LLC

Must not be taking: Vision-interfering drugs

Disqualifiers: Severe ocular pathology, Uncontrolled diabetes, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Intraoperative

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two devices, Centurion and Quatera 700, used in cataract surgery to determine which performs better. Cataract surgery clears cloudy vision by replacing the eye's lens, and the study aims to identify the superior device for this purpose. Individuals undergoing cataract surgery in both eyes and expecting improved vision after the procedure may be suitable candidates. Participants must agree to adhere to the study's schedule and guidelines. As an unphased trial, this study allows participants to contribute to advancements in cataract surgery technology.

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 prior data suggests that these phacoemulsification devices are safe for cataract surgery?

Research shows that the Quatera 700 device used in cataract surgery is safe and effective. Studies indicate that it maintains the eye's fluid balance during surgery, enhancing safety and comfort. One study found that the Quatera 700 better controlled incision leakage and used less fluid than the Centurion device, suggesting a lower risk of complications.

For the Centurion device, specific safety data is not provided in the sources. However, its widespread use in many surgeries suggests it is generally considered safe. Both devices aim to make cataract surgery smoother and help reduce recovery time, offering potential participants confidence in their safety profiles. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Quatera 700 system for cataract surgery because it introduces an advanced level of precision and control compared to traditional methods like the Centurion Vision System. Unlike older technologies, the Quatera 700 offers a fully automated, digitally integrated platform that enhances the surgeon's ability to perform cataract removal with greater accuracy. This system is designed to improve patient outcomes by reducing surgical time and potentially increasing the speed of recovery, making it an innovative step forward in eye surgery techniques.

What evidence suggests that these phacoemulsification devices are effective for cataract surgery?

This trial will compare the Quatera 700 system with the Centurion system for cataract surgery. Studies have shown that the Quatera 700 system, which participants in this trial may receive, can make cataract surgery safer and faster by maintaining eye stability during the procedure. It also uses less fluid, reducing stress on the eye. Research indicates that the Quatera 700 completes some surgery steps more quickly than other systems, such as the Signature Pro. In contrast, the Centurion system, another option in this trial, is known for its reliable performance in cataract surgeries and is widely trusted in the medical community. Both devices aim to enhance the precision and safety of cataract surgery, offering promising results for patients. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Centurion
• Quatera 700

Trial Overview 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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

Carolina Eyecare Physicians, LLC

Lead Sponsor

Trials

11

Recruited

600+

Science in Vision

Collaborator

Trials

17

Recruited

800+

Published Research Related to This Trial

In a study involving 204 patients undergoing cataract surgery, the Active Sentry handpiece demonstrated safety and efficacy comparable to the Ozil handpiece, with both groups showing similar postoperative visual outcomes and corneal edema rates.

Surgeons reported greater comfort using the Ozil handpiece during surgery, but the Active Sentry handpiece operated at lower intraocular pressure levels, which may enhance safety during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of two phacoemulsification system handpieces: prospective randomized comparative study. Cyril, D., Brahmani, P., Prasad, S., et al.[2022]

In a study involving 350 adults undergoing cataract surgery, 99.7% of participants achieved excellent visual acuity (CDVA ≤0.3 logMAR) 12 months after receiving the Clareon intraocular lens (IOL), indicating its high effectiveness.

The safety profile of the Clareon IOL was favorable, with serious adverse events occurring in less than 1% of subjects, and the most common nonserious issue being posterior capsule opacification in 5.4% of cases, which is within expected limits.

NCBI (Pubmed)

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. Lehmann, R., Maxwell, A., Lubeck, DM., et al.[2022]

Increasing intraocular pressure (IOP) during phacoemulsification significantly improves the efficiency of lens removal, as shown by a linear relationship between IOP and time to remove lens fragments in a laboratory study using porcine lenses.

Higher IOP also reduces the occurrence of 'chatter' (lens fragment repulsions from the tip), indicating that optimizing IOP can enhance the safety and effectiveness of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraocular pressure study using monitored forced-infusion system phacoemulsification technology. Jensen, JD., Boulter, T., Lambert, NG., et al.[2022]

In a study of 40 subjects undergoing bilateral cataract surgery, the trifocal intraocular lens (Alcon Acrysof IQ® PanOptix) provided significantly better uncorrected near visual acuity compared to the extended depth of focus lens (Tecnis® Symfony® ZXR00), indicating its superior performance for close-up vision.

Both lens types offered good visual outcomes for distance and intermediate vision, but the PanOptix lens also resulted in higher overall patient satisfaction scores, as measured by the NEI VFQ-25 questionnaire, suggesting it may enhance quality of life post-surgery.

NCBI (Pubmed)

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). Farvardin, M., Johari, M., Attarzade, A., et al.[2021]

In a study of 126 patients undergoing cataract surgery, the use of an intraocular pressure (IOP) based infusion system combined with the Intrepid balanced phaco tip significantly reduced cumulative dissipated energy (CDE), estimated fluid usage (EFU), and total aspiration time (TAT) compared to other combinations.

After 6 months, patients using the IOP based system with the Intrepid tip experienced significantly less loss in endothelial cell density, indicating better preservation of corneal health post-surgery.

NCBI (Pubmed)

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. Malik, PK., Dewan, T., Patidar, AK., et al.[2022]

In a study of 281 patients undergoing cataract surgery, the Active Sentry handpiece showed no significant advantages over the Centurion Ozil handpiece in terms of energy usage, surgery time, or postoperative outcomes.

Factors such as age, preoperative visual acuity, axial length, and ultrasound usage time were found to influence the number of active surge mitigation actuations, suggesting that the Active Sentry may be more beneficial in high-risk cataract cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect and Safety of Pressure Sensor-equipped Handpiece in Phacoemulsification System. Kim, JY., Kim, H., Jun, I., et al.[2023]

In a study involving 188 patients, both the AT LISA 809M and AcrySof ReSTOR SN6AD1 intraocular lenses (IOLs) showed similar postoperative visual symptoms and levels of patient satisfaction, indicating that both options are effective for cataract surgery.

Approximately 82.1% of patients with the AT LISA 809M IOL and 77.6% with the ReSTOR SN6AD1 IOL achieved complete spectacle independence, demonstrating that both lenses provide high rates of freedom from glasses post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of vision after bilateral multifocal intraocular lens implantation: a randomized trial--AT LISA 809M versus AcrySof ReSTOR SN6AD1. Maurino, V., Allan, BD., Rubin, GS., et al.[2022]

The Centurion® phacoemulsification system (CPS) demonstrated a 28.87% reduction in cumulated dissipated energy (CDE) compared to the Infiniti® phacoemulsification system (IPS) in patients with denser cataracts, indicating a more efficient surgical process.

Visual outcomes (VOs) at one month post-surgery were significantly improved with the CPS for patients with nuclear sclerosis grade III or greater, suggesting that CPS may be the preferred choice for cataract surgery in these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective study of Centurion® versus Infiniti® phacoemulsification systems: surgical and visual outcomes. Oh, LJ., Nguyen, CL., Wong, E., et al.[2020]

The study involved 86 eyes (55 using bimanual phacoemulsification and 31 using coaxial technique) and found that both techniques resulted in a mean best corrected visual acuity of 20/20 one day post-surgery, indicating high effectiveness.

While both techniques were safe, the bimanual approach showed a lower ultrasound output (22% vs. 28% for coaxial), and the use of the Mackool microphaco tip reduced iris impairment in the bimanual group, suggesting it may be a better option for minimizing ocular tissue damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cataract surgery using the bimanual phacoemulsification technique with an Accurus system and Mackool microphaco tip. Tanaka, T., Koshika, S., Usui, M.[2007]

The Alcon Centurion system with Active Sentry handpiece, using a lower intraocular pressure (IOP) setting of 30 mmHg, resulted in less corneal damage and lower pain complaints during cataract surgery compared to the gravity fluidics system set at 80 cmH2O, based on a study of 78 eyes from 53 patients.

Patients in the Active Fluidics System group experienced significantly lower corneal edema, smaller changes in central corneal thickness, and reduced endothelial cell loss after one month, indicating improved safety and comfort during the procedure.

NCBI (Pubmed)

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. Liu, Y., Hong, J., Chen, X.[2023]

In a study of 64 eyes from 32 patients undergoing cataract surgery, the SN60AT IOL with IMPRUV filter showed significantly better contrast sensitivity at lower frequencies (3 and 6 cycles per degree) compared to the Acrysof SA60 IOL.

The use of the tinted SN60AT lens improved contrast sensitivity without negatively impacting color perception, indicating its potential advantage in enhancing visual quality post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Intraocular lenses with blue light filter]. Cristóbal, JA., Sierra, J., Martín, J., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11430833/

Comparative Clinical Study of Surgical Performance ... The new Quatera 700 system resulted in lesser TPT, fluid turnover and phaco + I/A time than Signature Pro, while its performance was comparable to Centurion ...

2. zeiss.com zeiss.com/meditec/en/c/quatera-700/zeiss-quatera-700-ensures-chamber-stability.html

ZEISS QUATERA 700 Clinical study results showed that ZEISS QUATERA 700 had significantly lower mean fluid turnover in dense cataract group averaging 7.77 cc less than the ...

3. crstoday.com crstoday.com/quatera-700

Redefining Phacoemulsification Expectations with the ... When all the elements of phaco fluidics are balanced to achieve a stable anterior chamber, cataract surgery is safer, faster, and less taxing on the surgeon.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06225362

Study Details | NCT06225362 | Quatera 700 vs. Centurion The study evaluates 2 different phacoemulsification devices in patients undergoing routine cataract surgery in both eyes. Official Title. Evaluation and ...

5. journals.lww.com journals.lww.com/jcrs/fulltext/2023/09000/experimental_study_comparing_2_different.14.aspx

Journal of Cataract & Refractive Surgery Conclusions: Quatera demonstrated slightly higher surge peak values and notably shorter surge duration times after occlusion break than Centurion. Quatera ...

6. zeiss.com zeiss.com/meditec/en/myzeiss/peer-insights/articles/ophthalmic-surgery/insights-anterior-chamber-stability-and-safe-cataract-surgery.html

Insights: Anterior chamber stability and safe cataract surgery Mean chamber stability for both the soft and dense cataract subgroups, operated on with the QUATERA 700 was 1.1, indicating excellent stability ...