Cataract
Conditions
Keywords
Cataract, Phacoemulsification, Cumulative Dissipated Energy (CDE)
Brief summary
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.
Interventions
DEVICECENTURION® Vision System (CVS)
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.
DEVICEINFINITI® Vision System (IVS)
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.
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eligible to undergo cataract extraction via phacoemulsification with primary ACRYSOF Intraocular Lens (IOL) implantation; * Free of severe disease(s)/condition(s) listed in the Warnings and Precautions section of implanted ACRYSOF IOL; * Willing to undergo second eye surgery within 14 days of first eye surgery; * Willing and able to understand/sign a written Informed Consent Document; * Willing and able to return for scheduled follow-up examinations; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Planned multiple procedures at the time of surgery or during the course of the study (eg, LASIK, LRI, etc.); * Previous intraocular or corneal surgery of any kind; * Poorly dilating pupil; * Severe retinal disorders (eg, macular degeneration, proliferative diabetic retinopathy); * Corneal disease (eg, herpes simplex, herpes zoster, etc) or retinal detachment; * Severe conditions that per Investigator's clinical judgment would increase the operative risk or confound the result of this investigation; * Female patients who are pregnant, lactating, or planning to be pregnant during the course of the study; * Currently participating in another drug or device clinical trial, or participated in another drug or device clinical trial within 30 days of enrollment into this trial; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Dissipated Energy | Day 0 (operative day), each eye | 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. |
| Aspiration (ASP) Fluid Used | Day 0 (operative day), each eye | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aspiration Time | Day 0 (operative day), each eye | 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. |
Participant flow
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 73.0 years STANDARD_DEVIATION 7.7 |
| Sex: Female, Male Female | 67 Participants |
| Sex: Female, Male Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 11 / 98 |
| serious Total, serious adverse events | 2 / 98 |
Outcome results
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.
Time frame: Day 0 (operative day), each eye
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| CENTURION Vision System | Aspiration (ASP) Fluid Used | 46.56 grams | Standard Error 1.39 |
| INFINITI Vision System | Aspiration (ASP) Fluid Used | 52.68 grams | Standard Error 1.4 |
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.
Time frame: Day 0 (operative day), each eye
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| CENTURION Vision System | Cumulative Dissipated Energy | 4.32 percent-seconds | Standard Error 0.28 |
| INFINITI Vision System | Cumulative Dissipated Energy | 7.11 percent-seconds | Standard Error 0.28 |
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.
Time frame: Day 0 (operative day), each eye
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| CENTURION Vision System | Aspiration Time | 151.85 seconds | Standard Error 4.08 |
| INFINITI Vision System | Aspiration Time | 167.63 seconds | Standard Error 4.09 |