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The purpose of this study is to demonstrate that the Centurion® Vision System (CVS) used with the 45° Balanced Tip will result in less Cumulative Dissipated Energy (CDE) than the lnfiniti® Vision System (IVS) used with the 45° Mini-Flared Kelman (MFK) tip during cataract extraction surgery via phacoemulsification of cataract grades NII- NIV [Lens opacities classification system II (LOCSII)].
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CVS with 45° Balanced Tip | Experimental | Centurion® Vision System, 45° Balanced Tip used with INTREPID® Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up |
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| CVS with 45° MFK Tip | Active Comparator | Centurion® Vision System, 45° MFK Tip used with INTREPID® Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up |
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| IVS with 45° MFK Tip | Active Comparator | lnfiniti® Vision System, 45° MFK Tip used with Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Centurion® Vision System, 45° Balanced Tip | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Dissipated Energy (CDE) | Cumulative Dissipated Energy (CDE) represents the energy dissipated of the u/s tip and infusion sleeve at the incision point (5.6mm back from the cutting edge of the tip) during the removal of cataractous lens. CDE was reported on the Vision System interface and measured in percent-seconds. A lower CDE indicates that less energy was present at the incision site. Only one eye (study eye) contributed to the analysis. This outcome measure was pre-specified for CVS Bal and IVS MFK. | Day 0 (operative day) |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Dissipated Energy (CDE) | Cumulative Dissipated Energy (CDE) represents the energy dissipated of the u/s tip and infusion sleeve at the incision point (5.6mm back from the cutting edge of the tip) during the removal of cataractous lens. CDE was reported on the Vision System interface and measured in percent-seconds. A lower CDE indicates that less energy was present at the incision site. Only one eye (study eye) contributed to the analysis. |
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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 |
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Of the 231 subjects enrolled, 49 were exited prior to randomization (34 due to randomization suspension, 14 due to screen failure, and 1 due to subject death). This reporting group includes all randomized subjects (182).
Subjects were recruited from 4 study centers located in the United States (2), Hungary (1), and India (1).
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| ID | Title | Description |
|---|---|---|
| FG000 | CVS Bal | Centurion® Vision System (CVS), 45° Balanced Tip used with INTREPID® Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up |
| FG001 | CVS MFK |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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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 | Jul 18, 2016 | Mar 23, 2018 |
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| Centurion® Vision System, 45° MFK Tip |
| Device |
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| lnfiniti® Vision System, 45° MFK Tip | Device |
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| INTREPID® Ultra infusion sleeve | Device |
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| Ultra infusion sleeve | Device |
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| Day 0 (operative day) |
| Balanced Salt Solution (BSS) Fluid Used | BSS Fluid was measured by weighing the BSS bag after priming. BSS Used is Incision Leakage Fluid plus Aspiration Fluid Used. A reduction in BSS fluid used implies less induced trauma to tissues. Only one eye (study eye) contributed to the analysis. | Day 0 (operative day) |
CVS, 45° MFK Tip used with INTREPID® Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up
| FG002 | IVS MFK | lnfiniti® Vision System (IVS), 45° MFK Tip used with Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up |
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| Intent-to-Treat (ITT) | All randomized subjects who completed a procedure |
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| COMPLETED | All subjects who completed the study |
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| NOT COMPLETED |
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ITT
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| ID | Title | Description |
|---|---|---|
| BG000 | CVS Bal | CVS, 45° Balanced Tip used with INTREPID® Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up |
| BG001 | CVS MFK | CVS, 45° MFK Tip used with INTREPID® Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up |
| BG002 | IVS MFK | IVS, 45° MFK Tip used with Ultra Infusion Sleeve in one time routine surgical procedure followed by 3 months (+/- 14 days) of post-operative follow-up |
| BG003 | Total | Total of all reporting groups |
| 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 | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| 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) | Cumulative Dissipated Energy (CDE) represents the energy dissipated of the u/s tip and infusion sleeve at the incision point (5.6mm back from the cutting edge of the tip) during the removal of cataractous lens. CDE was reported on the Vision System interface and measured in percent-seconds. A lower CDE indicates that less energy was present at the incision site. Only one eye (study eye) contributed to the analysis. This outcome measure was pre-specified for CVS Bal and IVS MFK. | ITT with non-missing data | Posted | Mean | Standard Deviation | percent-seconds | Day 0 (operative day) |
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| Secondary | Cumulative Dissipated Energy (CDE) | Cumulative Dissipated Energy (CDE) represents the energy dissipated of the u/s tip and infusion sleeve at the incision point (5.6mm back from the cutting edge of the tip) during the removal of cataractous lens. CDE was reported on the Vision System interface and measured in percent-seconds. A lower CDE indicates that less energy was present at the incision site. Only one eye (study eye) contributed to the analysis. | ITT with non-missing data | Posted | Mean | Standard Deviation | percent-seconds | Day 0 (operative day) |
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| Secondary | Balanced Salt Solution (BSS) Fluid Used | BSS Fluid was measured by weighing the BSS bag after priming. BSS Used is Incision Leakage Fluid plus Aspiration Fluid Used. A reduction in BSS fluid used implies less induced trauma to tissues. Only one eye (study eye) contributed to the analysis. | ITT with non-missing data | Posted | Mean | Standard Deviation | milliliters (ml) | Day 0 (operative day) |
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Surgery through planned study completion, an average of 3 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Analysis population includes all randomized subjects for whom the procedure was attempted (Safety Analysis Set).
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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 | CVS Bal | Subjects exposed to CVS, 45° Balanced Tip | 0 | 57 | 1 | 57 | 14 | 57 |
| EG001 | CVS MFK | Subjects exposed to CVS, 45° MFK Tip | 0 | 57 | 0 | 57 | 17 | 57 |
| EG002 | IVS MFK | Subjects exposed to lVS, 45° MFK Tip | 0 | 59 | 3 | 59 | 11 | 59 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Posterior capsule rupture | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Vitreous loss | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
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| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
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| Vitrectomy | Surgical and medical procedures | MedDRA (18.0) | Systematic Assessment |
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| Hypertensive crisis | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal endothelial cell loss | Eye disorders | MedDRA (18.0) | Systematic Assessment | Inclusive of any cell loss >20% or under 1,500 cells/mm^2 |
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Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dir Surg Instrumentation, CDMA Surgical | Alcon, A Novartis Division | 1-888-451-3937 | alcon.medinfo@alcon.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 29, 2017 | Mar 23, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D015193 | Chorionic Villi Sampling |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D011296 | Prenatal Diagnosis |
| D003944 | Diagnostic Techniques, Obstetrical and Gynecological |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Units | Counts |
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| Participants |
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| Participants |
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