Quatera 700 vs. Centurion for Cataract Surgery

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

40 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{1 2 3 5 11}

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.

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.

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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 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]

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]

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]

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 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]

References

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

Prospective study of Centurion® versus Infiniti® phacoemulsification systems: surgical and visual outcomes. [2020]

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]

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]

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

Intraocular pressure study using monitored forced-infusion system phacoemulsification technology. [2022]

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

Effect and Safety of Pressure Sensor-equipped Handpiece in Phacoemulsification System. [2023]

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

Comparison of two phacoemulsification system handpieces: prospective randomized comparative study. [2022]

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]

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

[Intraocular lenses with blue light filter]. [2019]

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

Cataract surgery using the bimanual phacoemulsification technique with an Accurus system and Mackool microphaco tip. [2007]

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]

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]