Cataracts
Conditions
Brief summary
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 \[Lens opacities classification system II (LOCSII)\].
Interventions
DEVICECenturion® Vision System, 45° Balanced Tip
DEVICECenturion® Vision System, 45° MFK Tip
DEVICElnfiniti® Vision System, 45° MFK Tip
DEVICEINTREPID® Ultra infusion sleeve
DEVICEUltra infusion sleeve
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Willing and able to consent for participation; * Willing and able to attend postoperative examinations per protocol schedule; * Cataract in at least one eye with a Nuclear Opalescence of II-IV (via LOCSII) followed by posterior chamber intraocular lens (IOL) implantation; * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Planned multiple procedures, including Laser Phaco, LASIK, LRI's etc. during surgery or the course of this study; * Severe conditions of acute or chronic diseases or illnesses that would increase the operative risk or confound the result of this investigation; * Untreated or uncontrolled Glaucoma; * Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes; * Poorly dilating pupil or other pupil defect; * Current or previous use of an alpha-1-selective adrenoceptor blocking agent or antagonist of alpha 1A adrenoceptor (eg, Flomax®, Hyntrin®, or Cardura®); * Severe retinal disorders; * Corneal disease or retinal detachment; * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Dissipated Energy (CDE) | Day 0 (operative day) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Dissipated Energy (CDE) | Day 0 (operative day) | 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. |
| Balanced Salt Solution (BSS) Fluid Used | Day 0 (operative day) | 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. |
Participant flow
Recruitment details
Subjects were recruited from 4 study centers located in the United States (2), Hungary (1), and India (1).
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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 | 57 |
| 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 | 57 |
| 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 | 59 |
| Total | 173 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Disqualified due to cataract grading | 0 | 0 | 1 |
| Overall Study | Enrollment suspension | 4 | 1 | 1 |
| Overall Study | Lost to Follow-up | 2 | 2 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | CVS Bal | CVS MFK | IVS MFK | Total |
|---|---|---|---|---|
| Age, Continuous | 69.6 years STANDARD_DEVIATION 8.4 | 70.3 years STANDARD_DEVIATION 9.2 | 73.4 years STANDARD_DEVIATION 9.6 | 71.1 years STANDARD_DEVIATION 9.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 28 Participants | 31 Participants | 30 Participants | 89 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 26 Participants | 29 Participants | 84 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 30 Participants | 32 Participants | 36 Participants | 98 Participants |
| Sex: Female, Male Male | 27 Participants | 25 Participants | 23 Participants | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 57 | 0 / 57 | 0 / 59 |
| other Total, other adverse events | 14 / 57 | 17 / 57 | 11 / 59 |
| serious Total, serious adverse events | 1 / 57 | 0 / 57 | 3 / 59 |
Outcome results
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.
Time frame: Day 0 (operative day)
Population: ITT with non-missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CVS Bal | Cumulative Dissipated Energy (CDE) | 6.2 percent-seconds | Standard Deviation 2.9 |
| IVS MFK | Cumulative Dissipated Energy (CDE) | 11.4 percent-seconds | Standard Deviation 8.4 |
p-value: <0.001ANCOVA
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.
Time frame: Day 0 (operative day)
Population: ITT with non-missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CVS Bal | Balanced Salt Solution (BSS) Fluid Used | 95.8 milliliters (ml) | Standard Deviation 33.1 |
| IVS MFK | Balanced Salt Solution (BSS) Fluid Used | 101.7 milliliters (ml) | Standard Deviation 34.3 |
| IVS MFK | Balanced Salt Solution (BSS) Fluid Used | 94.1 milliliters (ml) | Standard Deviation 34.9 |
p-value: 0.52ANCOVA
p-value: 0.817ANCOVA
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.
Time frame: Day 0 (operative day)
Population: ITT with non-missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CVS Bal | Cumulative Dissipated Energy (CDE) | 6.2 percent-seconds | Standard Deviation 2.9 |
| IVS MFK | Cumulative Dissipated Energy (CDE) | 11.6 percent-seconds | Standard Deviation 7.3 |
| IVS MFK | Cumulative Dissipated Energy (CDE) | 11.4 percent-seconds | Standard Deviation 8.4 |
p-value: <0.001ANCOVA
p-value: 0.605ANCOVA