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The purpose of this study is to evaluate intra-operative phacoemulsification machine metrics after phacoemulsification with the CENTURION® vision system configuration compared with the INFINITI® vision system configuration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CENTURION | Experimental | First surgical eye randomized to CENTURION® Vision System, with second surgical eye (fellow eye) assigned to INFINITI® Vision System. Second eye surgery conducted within 14 days of the first eye surgery. Duration of surgery less than 30 minutes each eye. |
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| INFINITI | Active Comparator | First surgical eye randomized to INFINITI® Vision System, with second surgical eye (fellow eye) assigned to CENTURION® Vision System. Second eye surgery conducted within 14 days of the first eye surgery. Duration of surgery less than 30 minutes each eye. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CENTURION® Vision System (CVS) | Device | Phacoemulsification aspiration platform, with configuration consisting of Centurion® Vision System Phaco Emulsifier Aspirator, 45° Balanced ultrasonic tip, and INTREPID Ultra Infusion Sleeve, for use during routine cataract extraction by phacoemulsification with intraocular lens implantation. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Dissipated Energy | 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. | Day 0 (operative day), each eye |
| Aspiration (ASP) Fluid Used | 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. | Day 0 (operative day), each eye |
| Measure | Description | Time Frame |
|---|---|---|
| Aspiration Time | 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. | Day 0 (operative day), each eye |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erin Hayes, MS | Alcon Research | Study Director |
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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).
Participants were recruited from 2 investigative sites located in the US and 1 investigative site located in Spain.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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This reporting group includes all participants randomized to a surgical system.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cumulative Dissipated Energy | 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. | 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. | Posted | Least Squares Mean | Standard Error | percent-seconds | Day 0 (operative day), each eye |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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." |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vitreous detachment (Centurion) | Eye disorders | MedDRA (16.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Doug Fanney, Director, Global Medical Affairs, Cataract Instrumentation | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| INFINITI® Vision System (IVS) | Device | Phacoemulsification aspiration platform, with configuration consisting of Infiniti® Vision System Phaco Emulsifier Aspirator, 45° Mini Flared Kelman tip, and Ultra Infusion Sleeve, for use during routine cataract extraction by phacoemulsification with intraocular lens implantation. |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| OG001 | INFINITI Vision System | 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. |
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| Primary | Aspiration (ASP) Fluid Used | 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. | 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. | Posted | Least Squares Mean | Standard Error | grams | Day 0 (operative day), each eye |
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| Secondary | Aspiration Time | 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. | 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. | Posted | Least Squares Mean | Standard Error | seconds | Day 0 (operative day), each eye |
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| 2 |
| 98 |
| 11 |
| 98 |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
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| Intraocular pressure increased (Centurion) | Investigations | MedDRA (16.0) | Systematic Assessment |
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| Vitreous detachment (Infiniti) | Eye disorders | MedDRA (16.0) | Systematic Assessment |
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| Intraocular pressure increased (Infiniti) | Investigations | MedDRA (16.0) | Systematic Assessment |
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Sponsor reserves the right of prior review of any publication or presentation of information related to the study.