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

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ClinicalTrials.gov Identifier: NCT01848288
Recruitment Status : Completed
First Posted : May 7, 2013
Results First Posted : March 9, 2015
Last Update Posted : April 7, 2015
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Participant)
Condition Cataract
Interventions Device: CENTURION® Vision System (CVS)
Device: INFINITI® Vision System (IVS)
Enrollment 112
Recruitment Details Participants were recruited from 2 investigative sites located in the US and 1 investigative site located in Spain.
Pre-assignment Details Of the 112 enrolled, 12 participants were exited as screen failures prior to randomization. One participant was randomized twice in error. This reporting group includes all randomized participants (100).
Arm/Group Title Overall
Hide Arm/Group Description First surgical eye randomly assigned to CENTURION® Vision System or INFINITI® Vision System, with the second surgical eye (fellow eye) assigned to the alternative group.
Period Title: Overall Study
Started 100
Completed 97 [1]
Not Completed 3
Reason Not Completed
Death             1
Protocol Violation             1
Withdrawal by Subject             1
[1]
Two subjects were discontinued prior to undergoing surgery.
Arm/Group Title Overall
Hide Arm/Group Description First surgical eye randomly assigned to CENTURION® Vision System or INFINITI® Vision System, with the second surgical eye (fellow eye) assigned to the alternative group.
Overall Number of Baseline Participants 100
Hide Baseline Analysis Population Description
This reporting group includes all participants randomized to a surgical system.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants
73.0  (7.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
Female
67
  67.0%
Male
33
  33.0%
1.Primary Outcome
Title Cumulative Dissipated Energy
Hide Description 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.
Time Frame Day 0 (operative day), each eye
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title CENTURION Vision System INFINITI Vision System
Hide Arm/Group Description:
CENTURION® Vision System randomly assigned to first surgical eye, with INFINITI® Vision System assigned to second surgical eye (fellow eye). Each eye received a single treatment with estimated duration of less than 30 minutes. The second eye surgery occurred within 14 days of first eye surgery.
INFINITI® Vision System randomly assigned to first surgical eye, with CENTURION® Vision System assigned to second surgical eye (fellow eye). Each eye received a single treatment with estimated duration of less than 30 minutes. The second eye surgery occurred within 14 days of first eye surgery.
Overall Number of Participants Analyzed 98 97
Least Squares Mean (Standard Error)
Unit of Measure: percent-seconds
4.32  (0.28) 7.11  (0.28)
2.Primary Outcome
Title Aspiration (ASP) Fluid Used
Hide Description 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.
Time Frame Day 0 (operative day), each eye
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title CENTURION Vision System INFINITI Vision System
Hide Arm/Group Description:
CENTURION® Vision System randomly assigned to first surgical eye, with INFINITI® Vision System assigned to second surgical eye (fellow eye). Each eye received a single treatment with estimated duration of less than 30 minutes. The second eye surgery occurred within 14 days of first eye surgery.
INFINITI® Vision System randomly assigned to first surgical eye, with CENTURION® Vision System assigned to second surgical eye (fellow eye). Each eye received a single treatment with estimated duration of less than 30 minutes. The second eye surgery occurred within 14 days of first eye surgery.
Overall Number of Participants Analyzed 98 97
Least Squares Mean (Standard Error)
Unit of Measure: grams
46.56  (1.39) 52.68  (1.40)
3.Secondary Outcome
Title Aspiration Time
Hide Description 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.
Time Frame Day 0 (operative day), each eye
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title CENTURION Vision System INFINITI Vision System
Hide Arm/Group Description:
CENTURION® Vision System randomly assigned to first surgical eye, with INFINITI® Vision System assigned to second surgical eye (fellow eye). Each eye received a single treatment with estimated duration of less than 30 minutes. The second eye surgery occurred within 14 days of first eye surgery.
INFINITI® Vision System randomly assigned to first surgical eye, with CENTURION® Vision System assigned to second surgical eye (fellow eye). Each eye received a single treatment with estimated duration of less than 30 minutes. The second eye surgery occurred within 14 days of first eye surgery.
Overall Number of Participants Analyzed 98 97
Least Squares Mean (Standard Error)
Unit of Measure: seconds
151.85  (4.08) 167.63  (4.09)
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.
Adverse Event Reporting Description An AE was defined as any untoward medical occurrence in a subject who is administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether or not the event has a causal relationship with the treatment.
 
Arm/Group Title Overall
Hide Arm/Group Description First surgical eye randomly assigned to CENTURION® Vision System or INFINITI® Vision System, with the second surgical eye (fellow eye) assigned to the alternative group. For non-ocular adverse events, "at risk" population is included with unit of "subjects." For ocular adverse events, "at risk" population is included with unit of "eyes by treatment group."
All-Cause Mortality
Overall
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Overall
Affected / at Risk (%)
Total   2/98 (2.04%) 
Cardiac disorders   
Myocardial infarction  1  1/98 (1.02%) 
Infections and infestations   
Infective exacerbation of chronic obstructive airways disease  1  1/98 (1.02%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Overall
Affected / at Risk (%)
Total   11/98 (11.22%) 
Eye disorders   
Vitreous detachment (Centurion)  1  6/98 (6.12%) 
Vitreous detachment (Infiniti)  1  6/98 (6.12%) 
Investigations   
Intraocular pressure increased (Centurion)  1  4/98 (4.08%) 
Intraocular pressure increased (Infiniti)  1  5/98 (5.10%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
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: Doug Fanney, Director, Global Medical Affairs, Cataract Instrumentation
Organization: Alcon Research, Ltd.
Phone: 1-888-451-3937
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01848288     History of Changes
Other Study ID Numbers: M-13-006
First Submitted: May 1, 2013
First Posted: May 7, 2013
Results First Submitted: February 27, 2015
Results First Posted: March 9, 2015
Last Update Posted: April 7, 2015