Cataract
Conditions
Brief summary
The purpose of this study is to evaluate cumulative dissipated energy (CDE), endothelial cell loss, and average torsional amplitude with combination of LenSx® and Centurion® compared to conventional cataract surgery.
Detailed description
Subjects will attend 7 scheduled visits: 1 pre-operative, 1 operative, and 5 post-operative.
Interventions
PROCEDUREFLACS
Femtosecond laser assisted cataract surgery consisting of LenSx® and Centurion® combination
PROCEDUREManual conventional surgery
Removal of cataractous lens by phacoemulsification
DEVICECENTURION® Vision System
Phacoemulsification aspiration platform for use during cataract surgery
DEVICELenSx®
Femtosecond laser system used for continuous curvilinear capsulorhexis (CCC) and lens fragmentation during cataract surgery
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Cataracts (Grade 2-4 of Emery-Little Classification) with planned cataract removal by phacoemulsification in both eyes; * Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures; * Calculated lens power within the available range; * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Any pathology that could reduce visual potential; * Hypotony or the presence of a corneal implant; * Residual, recurrent, active ocular or eyelid disease; * Poorly dilating pupil; * Any contraindication to cataract; * Eyes with two different levels of cataract grade; * Pregnant, or planned pregnancy during the study; * Expected to require an ocular surgical treatment at any time during the study; * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Dissipated Energy (CDE) | Day 0 (operative day) | CDE is not expressed in standard units such as Watts or Joules and accounts for the power and time of longitudinal and torsional ultrasound delivery modes. CDE (the sum total of phacoemulsification energy dissipated at the incision point during the removal of cataractous lens with Centurion® Vision System footpedal in Position 3) was calculated by the Centurion® Vision System as follows: CDE = (Longitudinal time) x (Average longitudinal power) + (Torsional time x 0.4 x Average torsional amplitude). A lower CDE value indicates that less energy was expended in the eye. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change of Corneal Endothelial Cell Density (ECD) at Visit 5 (150-210 Days After Surgery) From Pre-Operative Visit | Preoperative, Day 150-210 (post-operative) | Central endothelial cell counts were assessed using specular microscopy. ECD was measured in cells per square millimeter (mm2). The endothelium maintains corneal hydration, and positive percent change value indicates an improvement. In turn, a less negative percent change value is preferable over a more negative percent change value. |
| Percentage of Average Torsional Amplitude | Day 0 (operative day) | Torsional amplitude (the amplitude of the oscillations of the phacoemulsification tip) was reported on the Centurion® Vision System interface as a percentage from 0 to 100, where 100 represents maximum amplitude. A lower percentage value indicates greater efficiency in the phacoemulsification process. |
Countries
Japan
Participant flow
Pre-assignment details
Of the 57 enrolled subjects, 2 subjects discontinued the study before surgery on the first operated eye. This reporting group includes all subjects for which cataract surgery was performed with the test device (regardless of success or failure) (Treatment-Emergent Safety Analysis Set)
Participants by arm
| Arm | Count |
|---|---|
| All Study Subjects Cataract extraction surgery with either FLACS or conventional technique allocated to each eye (within-subject), as randomized. Both eye surgeries occurred on the same day. | 55 |
| Total | 55 |
Baseline characteristics
| Characteristic | All Study Subjects | — |
|---|---|---|
| Age, Continuous | 73.2 years STANDARD_DEVIATION 6.6 | — |
| Age, Customized 60-69 | 15 years | — |
| Age, Customized 70-79 | 30 years | — |
| Age, Customized 80 and greater | 10 years | — |
| Age, Customized Less than 60 | 0 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Japan | 55 participants | — |
| Sex: Female, Male Female | 35 Participants | — |
| Sex: Female, Male Male | 20 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 55 | 0 / 55 |
| other Total, other adverse events | 0 / 55 | 0 / 55 | 0 / 55 |
| serious Total, serious adverse events | 0 / 55 | 0 / 55 | 2 / 55 |
Outcome results
Primary
Cumulative Dissipated Energy (CDE)
CDE is not expressed in standard units such as Watts or Joules and accounts for the power and time of longitudinal and torsional ultrasound delivery modes. CDE (the sum total of phacoemulsification energy dissipated at the incision point during the removal of cataractous lens with Centurion® Vision System footpedal in Position 3) was calculated by the Centurion® Vision System as follows: CDE = (Longitudinal time) x (Average longitudinal power) + (Torsional time x 0.4 x Average torsional amplitude). A lower CDE value indicates that less energy was expended in the eye.
Time frame: Day 0 (operative day)
Population: All eyes with successful cataract surgery for which anterior capsulotomy and lens fragmentation have been completed using the assigned surgical techniques (Full Analysis Set).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FLACS | Cumulative Dissipated Energy (CDE) | 0.213 unitless | Standard Deviation 0.334 |
| Conventional | Cumulative Dissipated Energy (CDE) | 1.718 unitless | Standard Deviation 0.898 |
p-value: <0.000195% CI: [-1.72, -1.289]t-test based on MMRM
Secondary
Percentage of Average Torsional Amplitude
Torsional amplitude (the amplitude of the oscillations of the phacoemulsification tip) was reported on the Centurion® Vision System interface as a percentage from 0 to 100, where 100 represents maximum amplitude. A lower percentage value indicates greater efficiency in the phacoemulsification process.
Time frame: Day 0 (operative day)
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FLACS | Percentage of Average Torsional Amplitude | 19.57 percentage of avg torsional amplitude | Standard Deviation 16.02 |
| Conventional | Percentage of Average Torsional Amplitude | 31.09 percentage of avg torsional amplitude | Standard Deviation 6.56 |
95% CI: [-15.87, -7.18]
Secondary
Percent Change of Corneal Endothelial Cell Density (ECD) at Visit 5 (150-210 Days After Surgery) From Pre-Operative Visit
Central endothelial cell counts were assessed using specular microscopy. ECD was measured in cells per square millimeter (mm2). The endothelium maintains corneal hydration, and positive percent change value indicates an improvement. In turn, a less negative percent change value is preferable over a more negative percent change value.
Time frame: Preoperative, Day 150-210 (post-operative)
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FLACS | Percent Change of Corneal Endothelial Cell Density (ECD) at Visit 5 (150-210 Days After Surgery) From Pre-Operative Visit | -1.5 percent change | Standard Deviation 5.6 |
| Conventional | Percent Change of Corneal Endothelial Cell Density (ECD) at Visit 5 (150-210 Days After Surgery) From Pre-Operative Visit | -2.7 percent change | Standard Deviation 5.2 |
p-value: 0.260295% CI: [-0.9, 3.3]t-test based on MMRM