Back to resultsComparison 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
Primary Purpose
Cataracts
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
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
Sponsored by
About this trial
This is an interventional treatment trial for Cataracts
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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®);
- Severe retinal disorders;
- Corneal disease or retinal detachment;
- Other protocol-specified exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
CVS with 45° Balanced Tip
CVS with 45° MFK Tip
IVS with 45° MFK Tip
Arm Description
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
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
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02502526
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
July 27, 2015 (Actual)
Primary Completion Date
March 23, 2017 (Actual)
Study Completion Date
November 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 cataract grades NII- NIV [Lens opacities classification system II (LOCSII)].
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataracts
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
231 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CVS with 45° Balanced Tip
Arm Type
Experimental
Arm Description
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
Arm Title
CVS with 45° MFK Tip
Arm Type
Active Comparator
Arm Description
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
Arm Title
IVS with 45° MFK Tip
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Centurion® Vision System, 45° Balanced Tip
Other Intervention Name(s)
CVS with 45° Balanced Tip
Intervention Type
Device
Intervention Name(s)
Centurion® Vision System, 45° MFK Tip
Other Intervention Name(s)
CVS with 45° MFK Tip
Intervention Type
Device
Intervention Name(s)
lnfiniti® Vision System, 45° MFK Tip
Other Intervention Name(s)
IVS with 45° MFK Tip
Intervention Type
Device
Intervention Name(s)
INTREPID® Ultra infusion sleeve
Intervention Type
Device
Intervention Name(s)
Ultra infusion sleeve
Primary Outcome Measure Information:
Title
Cumulative Dissipated Energy (CDE)
Description
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.
Time Frame
Day 0 (operative day)
Secondary Outcome Measure Information:
Title
Cumulative Dissipated Energy (CDE)
Description
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.
Time Frame
Day 0 (operative day)
Title
Balanced Salt Solution (BSS) Fluid Used
Description
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.
Time Frame
Day 0 (operative day)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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®);
Severe retinal disorders;
Corneal disease or retinal detachment;
Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alcon, A Novartis Division
Organizational Affiliation
Alcon, A Novartis Division
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
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
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