Trial Outcomes & Findings for Comparison of Centurion® Vision System With Balanced Tip and the Infiniti® Vision System With the Mini Flared Kelman (MFK) Tip During Cataract Extraction Surgery of Hard Lenses (NCT NCT02502526)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

231 participants

Primary outcome timeframe

Day 0 (operative day)

Results posted on

2018-07-02

Participant Flow

Subjects were recruited from 4 study centers located in the United States (2), Hungary (1), and India (1).

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).

Participant milestones

Participant milestones
Measure	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	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	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
Overall Study STARTED	62	59	61
Overall Study Intent-to-Treat (ITT)	57	57	59
Overall Study COMPLETED	56	55	55
Overall Study NOT COMPLETED	6	4	6

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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	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
Overall Study Lost to Follow-up	2	2	3
Overall Study Withdrawal by Subject	0	1	1
Overall Study Disqualified due to cataract grading	0	0	1
Overall Study Enrollment suspension	4	1	1

Baseline Characteristics

Comparison of Centurion® Vision System With Balanced Tip and the Infiniti® Vision System With the Mini Flared Kelman (MFK) Tip During Cataract Extraction Surgery of Hard Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CVS Bal n=57 Participants 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	CVS MFK n=57 Participants 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	IVS MFK n=59 Participants 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	Total n=173 Participants Total of all reporting groups
Age, Continuous	69.6 years STANDARD_DEVIATION 8.4 • n=5 Participants	70.3 years STANDARD_DEVIATION 9.2 • n=7 Participants	73.4 years STANDARD_DEVIATION 9.6 • n=5 Participants	71.1 years STANDARD_DEVIATION 9.2 • n=4 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	32 Participants n=7 Participants	36 Participants n=5 Participants	98 Participants n=4 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	25 Participants n=7 Participants	23 Participants n=5 Participants	75 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	28 Participants n=5 Participants	31 Participants n=7 Participants	30 Participants n=5 Participants	89 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants	26 Participants n=7 Participants	29 Participants n=5 Participants	84 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 0 (operative day)

Population: ITT with non-missing data

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.

Outcome measures

Outcome measures
Measure	CVS Bal n=57 Participants 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	IVS MFK n=58 Participants lVS, 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	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
Cumulative Dissipated Energy (CDE)	6.2 percent-seconds Standard Deviation 2.9	11.4 percent-seconds Standard Deviation 8.4	—

SECONDARY outcome

Timeframe: Day 0 (operative day)

Population: ITT with non-missing data

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.

Outcome measures

Outcome measures
Measure	CVS Bal n=57 Participants 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	IVS MFK n=57 Participants lVS, 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	IVS MFK n=58 Participants 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
Cumulative Dissipated Energy (CDE)	6.2 percent-seconds Standard Deviation 2.9	11.6 percent-seconds Standard Deviation 7.3	11.4 percent-seconds Standard Deviation 8.4

SECONDARY outcome

Timeframe: Day 0 (operative day)

Population: ITT with non-missing data

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.

Outcome measures

Outcome measures
Measure	CVS Bal n=57 Participants 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	IVS MFK n=57 Participants lVS, 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	IVS MFK n=58 Participants 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
Balanced Salt Solution (BSS) Fluid Used	95.8 milliliters (ml) Standard Deviation 33.1	101.7 milliliters (ml) Standard Deviation 34.3	94.1 milliliters (ml) Standard Deviation 34.9

Adverse Events

CVS Bal

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

CVS MFK

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

IVS MFK

Serious events: 3 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CVS Bal n=57 participants at risk Subjects exposed to CVS, 45° Balanced Tip	CVS MFK n=57 participants at risk Subjects exposed to CVS, 45° MFK Tip	IVS MFK n=59 participants at risk Subjects exposed to lVS, 45° MFK Tip
Eye disorders Posterior capsule rupture	1.8% 1/57 • 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).	0.00% 0/57 • 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).	0.00% 0/59 • 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).
Eye disorders Vitreous loss	1.8% 1/57 • 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).	0.00% 0/57 • 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).	0.00% 0/59 • 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).
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/57 • 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).	0.00% 0/57 • 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).	1.7% 1/59 • 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).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.00% 0/57 • 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).	0.00% 0/57 • 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).	1.7% 1/59 • 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).
Surgical and medical procedures Vitrectomy	1.8% 1/57 • 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).	0.00% 0/57 • 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).	0.00% 0/59 • 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).
Vascular disorders Hypertensive crisis	0.00% 0/57 • 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).	0.00% 0/57 • 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).	1.7% 1/59 • 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).

Other adverse events

Other adverse events
Measure	CVS Bal n=57 participants at risk Subjects exposed to CVS, 45° Balanced Tip	CVS MFK n=57 participants at risk Subjects exposed to CVS, 45° MFK Tip	IVS MFK n=59 participants at risk Subjects exposed to lVS, 45° MFK Tip
Eye disorders Corneal endothelial cell loss	24.6% 14/57 • 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).	29.8% 17/57 • 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).	18.6% 11/59 • 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).

Additional Information

Dir Surg Instrumentation, CDMA Surgical

Alcon, A Novartis Division

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER