CataractNCT01848288

Intra-Operative Metrics With CENTURION® and INFINITI® Vision Systems

A study testing CENTURION® Vision System (CVS) and INFINITI® Vision System (IVS) in people with Cataract, run by Alcon Research.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate intra-operative phacoemulsification machine metrics after phacoemulsification with the CENTURION® vision system configuration compared with the INFINITI® vision system configuration. Read more about this study

Who is it for?: Ages 55 years and older
Conditions the study is for: Cataract
What is being tested?: CENTURION® Vision System (CVS) and INFINITI® Vision System (IVS)
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 112 participants
Where: No sites listed yet
Study dates: Jul 2013to Feb 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Eligible to undergo cataract extraction via phacoemulsification with primary ACRYSOF Intraocular Lens (IOL) implantation;
Free of severe disease(s)/condition(s) listed in the "Warnings" and "Precautions" section of implanted ACRYSOF IOL;
Willing to undergo second eye surgery within 14 days of first eye surgery;
Willing and able to understand/sign a written Informed Consent Document;
Willing and able to return for scheduled follow-up examinations;
Other protocol-defined inclusion criteria may apply.

Who cannot join

Planned multiple procedures at the time of surgery or during the course of the study (eg, LASIK, LRI, etc.);
Previous intraocular or corneal surgery of any kind;
Poorly dilating pupil;
Severe retinal disorders (eg, macular degeneration, proliferative diabetic retinopathy);
Corneal disease (eg, herpes simplex, herpes zoster, etc) or retinal detachment;
Severe conditions that per Investigator's clinical judgment would increase the operative risk or confound the result of this investigation;

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Female patients who are pregnant, lactating, or planning to be pregnant during the course of the study;
Currently participating in another drug or device clinical trial, or participated in another drug or device clinical trial within 30 days of enrollment into this trial;
Other protocol-defined exclusion criteria may apply.

About this study

Official title: Intra-Operative Metrics and Clinical Outcomes After Cataract Surgery With the CENTURION® Vision System and the INFINITI® Vision System

Conditions: Cataract
Being tested: CENTURION® Vision System (CVS), INFINITI® Vision System (IVS)
Keywords: Cataract, Phacoemulsification, Cumulative Dissipated Energy (CDE)
Medical subject headings: Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CENTURION® Vision System (CVS)Device
Phacoemulsification aspiration platform, with configuration consisting of Centurion® Vision System Phaco Emulsifier Aspirator, 45° Balanced ultrasonic tip, and INTREPID Ultra Infusion Sleeve, for use during routine cataract extraction by phacoemulsification with intraocular lens implantation.
INFINITI® Vision System (IVS)Device
Phacoemulsification aspiration platform, with configuration consisting of Infiniti® Vision System Phaco Emulsifier Aspirator, 45° Mini Flared Kelman tip, and Ultra Infusion Sleeve, for use during routine cataract extraction by phacoemulsification with intraocular lens implantation.

Study groups in NCT01848288
Study group	Role	What they receive
CENTURION	Experimental	First surgical eye randomized to CENTURION® Vision System, with second surgical eye (fellow eye) assigned to INFINITI® Vision System. Second eye surgery conducted within 14 days of the first eye surgery. Duration of surgery less than 30 minutes each eye. Receives: Device: CENTURION® Vision System (CVS); Device: INFINITI® Vision System (IVS)
INFINITI	Active comparator	First surgical eye randomized to INFINITI® Vision System, with second surgical eye (fellow eye) assigned to CENTURION® Vision System. Second eye surgery conducted within 14 days of the first eye surgery. Duration of surgery less than 30 minutes each eye. Receives: Device: CENTURION® Vision System (CVS); Device: INFINITI® Vision System (IVS)

What is being measured

The primary outcome is the main question the study is designed to answer.

Cumulative Dissipated Energy
Cumulative Dissipated Energy (CDE) is an estimation of the energy at the incision site experienced during the removal of cataractous lens and is measured in %-secs. The incision is defined as 5.6mm back from the cutting edge of the tip. A lower CDE indicates that less energy was present at the incision site.
Measured: Day 0 (operative day), each eye
Aspiration (ASP) Fluid Used
Aspiration fluid used is the amount of aspiration fluid used during the removal of the cataractous lens. A lower value indicates that less fluid was removed from the eye.
Measured: Day 0 (operative day), each eye

Secondary outcomes (1)

Aspiration Time
Aspiration Time indicated the amount of time the system was aspirating during the removal of the cataractous lens. A lower value indicates that the surgeon spent less time aspirating fluid and material from the eye during surgery.
Measured: Day 0 (operative day), each eye

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2013Feb 2014

First posted7 May 2013 (estimated)
Study startJul 2013
Primary completionFeb 2014
Study completionFeb 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CataractStudies of the same condition, open and under way.
More trials run by Alcon ResearchThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Allocation: Randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 112 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01848288
Sponsor's protocol ID: M-13-006
Status last verified: Mar 2015
First submitted: 1 May 2013
Last updated: 7 Apr 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Cataract trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intra-Operative Metrics and Clinical Outcomes After Cataract Surgery With the CENTURION® Vision System and the INFINITI® Vision System
ClinicalTrials.gov ID: NCT01848288
Acronym / sponsor ID: M-13-006
Conditions: Cataract
Keywords: Cataract, Phacoemulsification, Cumulative Dissipated Energy (CDE)
Study type: Interventional
Recruitment status: Completed
Enrolment: 112 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Jul 2013
Primary completion: Feb 2014 (actual)
Study completion: Feb 2014 (actual)
First posted: 7 May 2013 (estimated)
Results: Posted 9 Mar 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Allocation: Randomised
Intervention model: Single group
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
CENTURION	Experimental	Device: CENTURION® Vision System (CVS), Device: INFINITI® Vision System (IVS)First surgical eye randomized to CENTURION® Vision System, with second surgical eye (fellow eye) assigned to INFINITI® Vision System. Second eye surgery conducted within 14 days of the first eye surgery. Duration of surgery less than 30 minutes each eye.
INFINITI	Active comparator	Device: CENTURION® Vision System (CVS), Device: INFINITI® Vision System (IVS)First surgical eye randomized to INFINITI® Vision System, with second surgical eye (fellow eye) assigned to CENTURION® Vision System. Second eye surgery conducted within 14 days of the first eye surgery. Duration of surgery less than 30 minutes each eye.

Who may qualify

Ages: 55 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Eligible to undergo cataract extraction via phacoemulsification with primary ACRYSOF Intraocular Lens (IOL) implantation;
Free of severe disease(s)/condition(s) listed in the "Warnings" and "Precautions" section of implanted ACRYSOF IOL;
Willing to undergo second eye surgery within 14 days of first eye surgery;
Willing and able to understand/sign a written Informed Consent Document;
Willing and able to return for scheduled follow-up examinations;

Key exclusion criteria (9 listed)

Planned multiple procedures at the time of surgery or during the course of the study (eg, LASIK, LRI, etc.);
Previous intraocular or corneal surgery of any kind;
Poorly dilating pupil;
Severe retinal disorders (eg, macular degeneration, proliferative diabetic retinopathy);
Corneal disease (eg, herpes simplex, herpes zoster, etc) or retinal detachment;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CENTURION® Vision System (CVS)Phacoemulsification aspiration platform, with configuration consisting of Centurion® Vision System Phaco Emulsifier Aspirator, 45° Balanced ultrasonic tip, and INTREPID Ultra Infusion Sleeve, for use during routine cataract extraction by phacoemulsification with intraocular lens implantation.	Device	CENTURION, INFINITI
INFINITI® Vision System (IVS)Phacoemulsification aspiration platform, with configuration consisting of Infiniti® Vision System Phaco Emulsifier Aspirator, 45° Mini Flared Kelman tip, and Ultra Infusion Sleeve, for use during routine cataract extraction by phacoemulsification with intraocular lens implantation.	Device	CENTURION, INFINITI

Primary outcome

Cumulative Dissipated Energy
Time frame: Day 0 (operative day), each eye
Cumulative Dissipated Energy (CDE) is an estimation of the energy at the incision site experienced during the removal of cataractous lens and is measured in %-secs. The incision is defined as 5.6mm back from the cutting edge of the tip. A lower CDE indicates that less energy was present at the incision site.
Aspiration (ASP) Fluid Used
Time frame: Day 0 (operative day), each eye
Aspiration fluid used is the amount of aspiration fluid used during the removal of the cataractous lens. A lower value indicates that less fluid was removed from the eye.

1 secondary outcome

Aspiration Time
Time frame: Day 0 (operative day), each eye

Results and safety

Results posted to the registry on 9 Mar 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Overall	100	97

Primary outcome: Cumulative Dissipated Energy

Time frame: Day 0 (operative day), each eye. Least squares mean (Standard Error). Unit: percent-seconds

Measure	CENTURION Vision System n = 98	INFINITI Vision System n = 97
Value	4.32 (0.28)	7.11 (0.28)

Population analysed: This analysis population includes all participants who were randomized to a surgical system and had non-missing values at the specific time point for each arm group, respectively.

Primary outcome: Aspiration (ASP) Fluid Used

Time frame: Day 0 (operative day), each eye. Least squares mean (Standard Error). Unit: grams

Measure	CENTURION Vision System n = 98	INFINITI Vision System n = 97
Value	46.56 (1.39)	52.68 (1.40)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected for the duration of the study (01 Jul 2013 - 07 Feb 2014). This analysis group includes all participants who were randomized and treated.. Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Overall	2 of 98 (2%)	11 of 98 (11.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Cataract

Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
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Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Erin Hayes, MS study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A study testing CENTURION® Vision System (CVS) and INFINITI® Vision System (IVS) in people with Cataract, run by Alcon Research.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative Dissipated Energy (time frame: Day 0 (operative day), each eye). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01848288.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.