CataractsNCT02502526

Comparison of Centurion® Vision System With Balanced Tip and the Infiniti® Vision System With the Mini Flared Kelman (MFK) Tip During Cataract Extraction Surgery of Hard Lenses

A study testing Centurion® Vision System, 45° Balanced Tip, Centurion® Vision System, 45° MFK Tip and lnfiniti® Vision System, 45° MFK Tip in people with Cataracts, 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 demonstrate that the Centurion® Vision System (CVS) used with the 45° Balanced Tip will result in less Cumulative Dissipated Energy (CDE) than the lnfiniti® Vision System (IVS) used with the 45° Mini-Flared Kelman (MFK) tip during cataract extraction surgery via phacoemulsification of… Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Cataracts
What is being tested?: Centurion® Vision System, 45° Balanced Tip, Centurion® Vision System, 45° MFK Tip and lnfiniti® Vision System, 45° MFK Tip
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 231 participants
Where: No sites listed yet
Study dates: 27 Jul 2015to 30 Nov 2017
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 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Willing and able to consent for participation;
Willing and able to attend postoperative examinations per protocol schedule;
Cataract in at least one eye with a Nuclear Opalescence of II-IV (via LOCSII) followed by posterior chamber intraocular lens (IOL) implantation;
Other protocol-specified inclusion criteria may apply.

Who cannot join

Planned multiple procedures, including Laser Phaco, LASIK, LRI's etc. during surgery or the course of this study;
Severe conditions of acute or chronic diseases or illnesses that would increase the operative risk or confound the result of this investigation;
Untreated or uncontrolled Glaucoma;
Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes;
Poorly dilating pupil or other pupil defect;
Current or previous use of an alpha-1-selective adrenoceptor blocking agent or antagonist of alpha 1A adrenoceptor (eg, Flomax®, Hyntrin®, or Cardura®);

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Severe retinal disorders;
Corneal disease or retinal detachment;
Other protocol-specified exclusion criteria may apply.

About this study

Official title: Comparison of Cumulative Dissipated Energy (CDE) and Balanced Salt Solution (BSS) Fluid Used With the Centurion® With the 45° Degree Balanced Ultrasound (U/S) Tip vs the Centurion® With Mini Flared Kelman U/S Tip vs the Infiniti® With Mini Flared Kelman U/S Tip on Hard Lenses

Conditions: Cataracts
Being tested: Centurion® Vision System, 45° Balanced Tip, Centurion® Vision System, 45° MFK Tip, lnfiniti® Vision System, 45° MFK Tip, INTREPID® Ultra infusion sleeve, Ultra infusion sleeve
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, 45° Balanced TipDevice
Also called CVS with 45° Balanced Tip
Centurion® Vision System, 45° MFK TipDevice
Also called CVS with 45° MFK Tip
lnfiniti® Vision System, 45° MFK TipDevice
Also called IVS with 45° MFK Tip
INTREPID® Ultra infusion sleeveDevice
Ultra infusion sleeveDevice

Study groups in NCT02502526
Study group	Role	What they receive
CVS with 45° Balanced Tip	Experimental	Centurion® Vision System, 45° Balanced Tip used with INTREPID® Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up Receives: Device: Centurion® Vision System, 45° Balanced Tip; Device: INTREPID® Ultra infusion sleeve
CVS with 45° MFK Tip	Active comparator	Centurion® Vision System, 45° MFK Tip used with INTREPID® Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up Receives: Device: Centurion® Vision System, 45° MFK Tip; Device: INTREPID® Ultra infusion sleeve
IVS with 45° MFK Tip	Active comparator	lnfiniti® Vision System, 45° MFK Tip used with Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up Receives: Device: lnfiniti® Vision System, 45° MFK Tip; Device: Ultra infusion sleeve

What is being measured

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

Cumulative Dissipated Energy (CDE)
Cumulative Dissipated Energy (CDE) represents the energy dissipated of the u/s tip and infusion sleeve at the incision point (5.6mm back from the cutting edge of the tip) during the removal of cataractous lens. CDE was reported on the Vision System interface and measured in percent-seconds. A lower CDE indicates that less energy was present at the incision site. Only one eye (study eye) contributed to the analysis. This outcome measure was pre-specified for CVS Bal and IVS MFK.
Measured: Day 0 (operative day)

Secondary outcomes (2)

Cumulative Dissipated Energy (CDE)
Cumulative Dissipated Energy (CDE) represents the energy dissipated of the u/s tip and infusion sleeve at the incision point (5.6mm back from the cutting edge of the tip) during the removal of cataractous lens. CDE was reported on the Vision System interface and measured in percent-seconds. A lower CDE indicates that less energy was present at the incision site. Only one eye (study eye) contributed to the analysis.
Measured: Day 0 (operative day)
Balanced Salt Solution (BSS) Fluid Used
BSS Fluid was measured by weighing the BSS bag after priming. BSS Used is Incision Leakage Fluid plus Aspiration Fluid Used. A reduction in BSS fluid used implies less induced trauma to tissues. Only one eye (study eye) contributed to the analysis.
Measured: Day 0 (operative day)

Timeline

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

27 Jul 201530 Nov 2017

First posted20 Jul 2015 (estimated)
Study start27 Jul 2015
Primary completion23 Mar 2017
Study completion30 Nov 2017

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 CataractsStudies 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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 231 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02502526
Sponsor's protocol ID: CTU424-P001
Status last verified: Apr 2018
First submitted: 13 Jul 2015
Last updated: 2 Jul 2018
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 Cataracts trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Cumulative Dissipated Energy (CDE) and Balanced Salt Solution (BSS) Fluid Used With the Centurion® With the 45° Degree Balanced Ultrasound (U/S) Tip vs the Centurion® With Mini Flared Kelman U/S Tip vs the Infiniti® With Mini Flared Kelman U/S Tip on Hard Lenses
ClinicalTrials.gov ID: NCT02502526
Acronym / sponsor ID: CTU424-P001
Conditions: Cataracts
Study type: Interventional
Recruitment status: Completed
Enrolment: 231 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 27 Jul 2015 (actual)
Primary completion: 23 Mar 2017 (actual)
Study completion: 30 Nov 2017 (actual)
First posted: 20 Jul 2015 (estimated)
Results: Posted 18 Apr 2018

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
CVS with 45° Balanced Tip	Experimental	Device: Centurion® Vision System, 45° Balanced Tip, Device: INTREPID® Ultra infusion sleeveCenturion® Vision System, 45° Balanced Tip used with INTREPID® Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up
CVS with 45° MFK Tip	Active comparator	Device: Centurion® Vision System, 45° MFK Tip, Device: INTREPID® Ultra infusion sleeveCenturion® Vision System, 45° MFK Tip used with INTREPID® Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up
IVS with 45° MFK Tip	Active comparator	Device: lnfiniti® Vision System, 45° MFK Tip, Device: Ultra infusion sleevelnfiniti® Vision System, 45° MFK Tip used with Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Willing and able to consent for participation;
Willing and able to attend postoperative examinations per protocol schedule;
Cataract in at least one eye with a Nuclear Opalescence of II-IV (via LOCSII) followed by posterior chamber intraocular lens (IOL) implantation;
Other protocol-specified inclusion criteria may apply.

Key exclusion criteria (9 listed)

Planned multiple procedures, including Laser Phaco, LASIK, LRI's etc. during surgery or the course of this study;
Severe conditions of acute or chronic diseases or illnesses that would increase the operative risk or confound the result of this investigation;
Untreated or uncontrolled Glaucoma;
Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes;
Poorly dilating pupil or other pupil defect;

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, 45° Balanced TipAlso: CVS with 45° Balanced Tip	Device	CVS with 45° Balanced Tip
Centurion® Vision System, 45° MFK TipAlso: CVS with 45° MFK Tip	Device	CVS with 45° MFK Tip
lnfiniti® Vision System, 45° MFK TipAlso: IVS with 45° MFK Tip	Device	IVS with 45° MFK Tip
INTREPID® Ultra infusion sleeve	Device	CVS with 45° Balanced Tip, CVS with 45° MFK Tip
Ultra infusion sleeve	Device	IVS with 45° MFK Tip

Primary outcome

Cumulative Dissipated Energy (CDE)
Time frame: Day 0 (operative day)
Cumulative Dissipated Energy (CDE) represents the energy dissipated of the u/s tip and infusion sleeve at the incision point (5.6mm back from the cutting edge of the tip) during the removal of cataractous lens. CDE was reported on the Vision System interface and measured in percent-seconds. A lower CDE indicates that less energy was present at the incision site. Only one eye (study eye) contributed to the analysis. This outcome measure was pre-specified for CVS Bal and IVS MFK.

2 secondary outcomes

Cumulative Dissipated Energy (CDE)
Time frame: Day 0 (operative day)
Balanced Salt Solution (BSS) Fluid Used
Time frame: Day 0 (operative day)

Results and safety

Results posted to the registry on 18 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CVS Bal	62	56
CVS MFK	59	55
IVS MFK	61	55

Primary outcome: Cumulative Dissipated Energy (CDE)

Time frame: Day 0 (operative day). Mean (Standard Deviation). Unit: percent-seconds

Measure	CVS Bal n = 57	IVS MFK n = 58
Value	6.2 (2.9)	11.4 (8.4)

CVS Bal vs IVS MFK: p <.001, ANCOVA

Population analysed: ITT with non-missing data

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Surgery through planned study completion, an average of 3 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CVS Bal	1 of 57 (1.8%)	14 of 57 (24.6%)	0 of 57
CVS MFK	0 of 57 (0%)	17 of 57 (29.8%)	0 of 57
IVS MFK	3 of 59 (5.1%)	11 of 59 (18.6%)	0 of 59

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Cataracts

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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
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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.

Alcon, A Novartis Division study director

Alcon, A Novartis Division

Questions about this trial

What is this clinical trial studying?

A study testing Centurion® Vision System, 45° Balanced Tip, Centurion® Vision System, 45° MFK Tip and lnfiniti® Vision System, 45° MFK Tip in people with Cataracts, 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 4 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 2 Jul 2018. 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 18 Apr 2018). 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 (CDE) (time frame: Day 0 (operative day)). 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 NCT02502526.

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 2 Jul 2018.