Trial Outcomes & Findings for Intra-Operative Metrics With CENTURION® and INFINITI® Vision Systems (NCT NCT01848288)
NCT ID: NCT01848288
Last Updated: 2015-04-07
Results Overview
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.
COMPLETED
NA
112 participants
Day 0 (operative day), each eye
2015-04-07
Participant Flow
Participants were recruited from 2 investigative sites located in the US and 1 investigative site located in Spain.
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).
Participant milestones
| Measure |
Overall
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 Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
97
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Overall
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 Study
Death
|
1
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Intra-Operative Metrics With CENTURION® and INFINITI® Vision Systems
Baseline characteristics by cohort
| Measure |
Overall
n=100 Participants
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.
|
|---|---|
|
Age, Continuous
|
73.0 years
STANDARD_DEVIATION 7.7 • n=99 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Day 0 (operative day), each eyePopulation: 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.
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.
Outcome measures
| Measure |
CENTURION Vision System
n=98 Participants
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
n=97 Participants
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.
|
|---|---|---|
|
Cumulative Dissipated Energy
|
4.32 percent-seconds
Standard Error 0.28
|
7.11 percent-seconds
Standard Error 0.28
|
PRIMARY outcome
Timeframe: Day 0 (operative day), each eyePopulation: 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.
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.
Outcome measures
| Measure |
CENTURION Vision System
n=98 Participants
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
n=97 Participants
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.
|
|---|---|---|
|
Aspiration (ASP) Fluid Used
|
46.56 grams
Standard Error 1.39
|
52.68 grams
Standard Error 1.40
|
SECONDARY outcome
Timeframe: Day 0 (operative day), each eyePopulation: 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.
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.
Outcome measures
| Measure |
CENTURION Vision System
n=98 Participants
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
n=97 Participants
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.
|
|---|---|---|
|
Aspiration Time
|
151.85 seconds
Standard Error 4.08
|
167.63 seconds
Standard Error 4.09
|
Adverse Events
Overall
Serious adverse events
| Measure |
Overall
n=98 participants at risk
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."
|
|---|---|
|
Cardiac disorders
Myocardial infarction
|
1.0%
1/98 • 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.
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.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
1.0%
1/98 • 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.
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.
|
Other adverse events
| Measure |
Overall
n=98 participants at risk
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."
|
|---|---|
|
Eye disorders
Vitreous detachment (Centurion)
|
6.1%
6/98 • 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.
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.
|
|
Investigations
Intraocular pressure increased (Centurion)
|
4.1%
4/98 • 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.
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.
|
|
Eye disorders
Vitreous detachment (Infiniti)
|
6.1%
6/98 • 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.
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.
|
|
Investigations
Intraocular pressure increased (Infiniti)
|
5.1%
5/98 • 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.
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.
|
Additional Information
Doug Fanney, Director, Global Medical Affairs, Cataract Instrumentation
Alcon Research, Ltd.
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER