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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.
Subjects will attend 7 scheduled visits: 1 pre-operative, 1 operative, and 5 post-operative.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FLACS | Experimental | Femtosecond laser assisted cataract surgery (FLACS) in 1 eye, with manual conventional surgery in the fellow eye, as randomized |
|
| Conventional | Active Comparator | Manual conventional surgery in 1 eye, with FLACS in the fellow eye, as randomized |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FLACS | Procedure | Femtosecond laser assisted cataract surgery consisting of LenSx® and Centurion® combination |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0 (operative day) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alcon, A Novartis Division | Alcon, A Novartis Division | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigative Site | Iizuka | Fukuoka | 820-0067 | Japan |
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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)
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Treatment Emergent Safety Analysis Set
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 (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. | All eyes with successful cataract surgery for which anterior capsulotomy and lens fragmentation have been completed using the assigned surgical techniques (Full Analysis Set). | Posted | Mean | Standard Deviation | unitless | Day 0 (operative day) | eyes | eyes |
|
Adverse events were collected from the time of initial treatment through study conclusion, for an average individual duration of 150 to 120 days.
An adverse event was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device (test article).
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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 | Ocular Adverse Events - FLACS | All subjects/eyes for which cataract surgery was performed with FLACS (regardless of success or failure) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chondrocalcinosis pyrophosphate | Musculoskeletal and connective tissue disorders | 22.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Group Manager, Surgical, Alcon Japan | Alcon Japan Ltd. | 03-6899-5061 | alcon.medinfo@alcon.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 18, 2018 | Oct 25, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 5, 2018 | Oct 25, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Manual conventional surgery | Procedure | Removal of cataractous lens by phacoemulsification |
|
| CENTURION® Vision System | Device | Phacoemulsification aspiration platform for use during cataract surgery |
|
| LenSx® | Device | Femtosecond laser system used for continuous curvilinear capsulorhexis (CCC) and lens fragmentation during cataract surgery |
|
| Preoperative, Day 150-210 (post-operative) |
| 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. | Day 0 (operative day) |
| years |
|
| Age, Customized | Number | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Conventional | Manual cataract surgery with Centurion® Vision System |
|
|
|
| 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. | Full Analysis Set | Posted | Mean | Standard Deviation | percent change | Preoperative, Day 150-210 (post-operative) | eyes | eyes |
|
|
|
|
| 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. | Full Analysis Set | Posted | Mean | Standard Deviation | percentage of avg torsional amplitude | Day 0 (operative day) | eyes | eyes |
|
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | Ocular Adverse Events - Conventional | All subjects/eyes for which cataract surgery was performed with Conventional technique (regardless of success or failure) | 0 | 55 | 0 | 55 | 0 | 55 |
| EG002 | Non-Ocular Adverse Events | All subjects for which cataract surgery was performed (regardless of success or failure) | 0 | 55 | 2 | 55 | 0 | 55 |
| Epilepsy | Nervous system disorders | 22.0 | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.