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Trial record 3 of 113 for:    centurion

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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ClinicalTrials.gov Identifier: NCT02502526
Recruitment Status : Completed
First Posted : July 20, 2015
Results First Posted : April 18, 2018
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Cataracts
Interventions Device: Centurion® Vision System, 45° Balanced Tip
Device: Centurion® Vision System, 45° MFK Tip
Device: lnfiniti® Vision System, 45° MFK Tip
Device: INTREPID® Ultra infusion sleeve
Device: Ultra infusion sleeve
Enrollment 231
Recruitment Details Subjects were recruited from 4 study centers located in the United States (2), Hungary (1), and India (1).
Pre-assignment Details Of the 231 subjects enrolled, 49 were exited prior to randomization (34 due to randomization suspension, 14 due to screen failure, and 1 due to subject death). This reporting group includes all randomized subjects (182).
Arm/Group Title CVS Bal CVS MFK IVS MFK
Hide Arm/Group Description Centurion® Vision System (CVS), 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, 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 (IVS), 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
Period Title: Overall Study
Started [1] 62 59 61
Intent-to-Treat (ITT) [2] 57 57 59
Completed [3] 56 55 55
Not Completed 6 4 6
Reason Not Completed
Lost to Follow-up             2             2             3
Withdrawal by Subject             0             1             1
Disqualified due to cataract grading             0             0             1
Enrollment suspension             4             1             1
[1]
All randomized subjects
[2]
All randomized subjects who completed a procedure
[3]
All subjects who completed the study
Arm/Group Title CVS Bal CVS MFK IVS MFK Total
Hide Arm/Group Description CVS, 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, 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, 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 Total of all reporting groups
Overall Number of Baseline Participants 57 57 59 173
Hide Baseline Analysis Population Description
ITT
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 57 participants 57 participants 59 participants 173 participants
69.6  (8.4) 70.3  (9.2) 73.4  (9.6) 71.1  (9.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 57 participants 59 participants 173 participants
Female
30
  52.6%
32
  56.1%
36
  61.0%
98
  56.6%
Male
27
  47.4%
25
  43.9%
23
  39.0%
75
  43.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 57 participants 59 participants 173 participants
Hispanic or Latino
28
  49.1%
31
  54.4%
30
  50.8%
89
  51.4%
Not Hispanic or Latino
29
  50.9%
26
  45.6%
29
  49.2%
84
  48.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Cumulative Dissipated Energy (CDE)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT with non-missing data
Arm/Group Title CVS Bal IVS MFK
Hide Arm/Group Description:
CVS, 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
lVS, 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
Overall Number of Participants Analyzed 57 58
Mean (Standard Deviation)
Unit of Measure: percent-seconds
6.2  (2.9) 11.4  (8.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CVS Bal, IVS MFK
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Cumulative Dissipated Energy (CDE)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT with non-missing data
Arm/Group Title CVS Bal CVS MFK IVS MFK
Hide Arm/Group Description:
CVS, 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, 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, 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
Overall Number of Participants Analyzed 57 57 58
Mean (Standard Deviation)
Unit of Measure: percent-seconds
6.2  (2.9) 11.6  (7.3) 11.4  (8.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CVS Bal, CVS MFK
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CVS MFK, IVS MFK
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.605
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title Balanced Salt Solution (BSS) Fluid Used
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT with non-missing data
Arm/Group Title CVS Bal CVS MFK IVS MFK
Hide Arm/Group Description:
CVS, 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, 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, 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
Overall Number of Participants Analyzed 57 57 58
Mean (Standard Deviation)
Unit of Measure: milliliters (ml)
95.8  (33.1) 101.7  (34.3) 94.1  (34.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CVS Bal, IVS MFK
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.520
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CVS MFK, IVS MFK
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.817
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame Surgery through planned study completion, an average of 3 months
Adverse Event Reporting Description An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Analysis population includes all randomized subjects for whom the procedure was attempted (Safety Analysis Set).
 
Arm/Group Title CVS Bal CVS MFK IVS MFK
Hide Arm/Group Description Subjects exposed to CVS, 45° Balanced Tip Subjects exposed to CVS, 45° MFK Tip Subjects exposed to lVS, 45° MFK Tip
All-Cause Mortality
CVS Bal CVS MFK IVS MFK
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/57 (0.00%)   0/57 (0.00%)   0/59 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
CVS Bal CVS MFK IVS MFK
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/57 (1.75%)   0/57 (0.00%)   3/59 (5.08%) 
Eye disorders       
Posterior capsule rupture  1  1/57 (1.75%)  0/57 (0.00%)  0/59 (0.00%) 
Vitreous loss  1  1/57 (1.75%)  0/57 (0.00%)  0/59 (0.00%) 
Injury, poisoning and procedural complications       
Subdural haematoma  1  0/57 (0.00%)  0/57 (0.00%)  1/59 (1.69%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Colon cancer metastatic  1  0/57 (0.00%)  0/57 (0.00%)  1/59 (1.69%) 
Surgical and medical procedures       
Vitrectomy  1  1/57 (1.75%)  0/57 (0.00%)  0/59 (0.00%) 
Vascular disorders       
Hypertensive crisis  1  0/57 (0.00%)  0/57 (0.00%)  1/59 (1.69%) 
1
Term from vocabulary, MedDRA (18.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CVS Bal CVS MFK IVS MFK
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/57 (24.56%)   17/57 (29.82%)   11/59 (18.64%) 
Eye disorders       
Corneal endothelial cell loss  1 [1]  14/57 (24.56%)  17/57 (29.82%)  11/59 (18.64%) 
1
Term from vocabulary, MedDRA (18.0)
Indicates events were collected by systematic assessment
[1]
Inclusive of any cell loss >20% or under 1,500 cells/mm^2
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
Name/Title: Dir Surg Instrumentation, CDMA Surgical
Organization: Alcon, A Novartis Division
Phone: 1-888-451-3937
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02502526     History of Changes
Other Study ID Numbers: CTU424-P001
First Submitted: July 13, 2015
First Posted: July 20, 2015
Results First Submitted: March 23, 2018
Results First Posted: April 18, 2018
Last Update Posted: July 2, 2018