Trial Outcomes & Findings for Clinical Evaluation of FLACS With Combination of LenSx® and Centurion® (NCT NCT03479944)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

57 participants

Primary outcome timeframe

Day 0 (operative day)

Results posted on

2019-12-16

Participant Flow

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)

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	55 110
Overall Study FLACS	55 55
Overall Study Conventional	55 55
Overall Study Full Analysis Set	53 106
Overall Study COMPLETED	55 110
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Subjects n=55 Participants 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.
Age, Continuous	73.2 years STANDARD_DEVIATION 6.6 • n=55 Participants
Age, Customized Less than 60	0 years n=55 Participants
Age, Customized 60-69	15 years n=55 Participants
Age, Customized 70-79	30 years n=55 Participants
Age, Customized 80 and greater	10 years n=55 Participants
Sex: Female, Male Female	35 Participants n=55 Participants
Sex: Female, Male Male	20 Participants n=55 Participants
Region of Enrollment Japan	55 participants n=55 Participants

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	FLACS n=53 eyes Femtosecond laser assisted cataract surgery (FLACS) with LenSx® and Centurion® Vision System in combination	Conventional n=53 eyes Manual cataract surgery with Centurion® Vision System
Cumulative Dissipated Energy (CDE)	0.213 unitless Standard Deviation 0.334	1.718 unitless Standard Deviation 0.898

SECONDARY outcome

Timeframe: Preoperative, Day 150-210 (post-operative)

Population: Full Analysis Set

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.

Outcome measures

Outcome measures
Measure	FLACS n=53 eyes Femtosecond laser assisted cataract surgery (FLACS) with LenSx® and Centurion® Vision System in combination	Conventional n=53 eyes Manual cataract surgery with Centurion® Vision System
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	-2.7 percent change Standard Deviation 5.2

SECONDARY outcome

Timeframe: Day 0 (operative day)

Population: Full Analysis Set

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.

Outcome measures

Outcome measures
Measure	FLACS n=53 eyes Femtosecond laser assisted cataract surgery (FLACS) with LenSx® and Centurion® Vision System in combination	Conventional n=53 eyes Manual cataract surgery with Centurion® Vision System
Percentage of Average Torsional Amplitude	19.57 percentage of avg torsional amplitude Standard Deviation 16.02	31.09 percentage of avg torsional amplitude Standard Deviation 6.56

Adverse Events

Ocular Adverse Events - FLACS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ocular Adverse Events - Conventional

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-Ocular Adverse Events

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ocular Adverse Events - FLACS n=55 participants at risk All subjects/eyes for which cataract surgery was performed with FLACS (regardless of success or failure)	Ocular Adverse Events - Conventional n=55 participants at risk All subjects/eyes for which cataract surgery was performed with Conventional technique (regardless of success or failure)	Non-Ocular Adverse Events n=55 participants at risk All subjects for which cataract surgery was performed (regardless of success or failure)
Musculoskeletal and connective tissue disorders Chondrocalcinosis pyrophosphate	0.00% 0/55 • 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).	0.00% 0/55 • 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).	1.8% 1/55 • 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).
Nervous system disorders Epilepsy	0.00% 0/55 • 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).	0.00% 0/55 • 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).	1.8% 1/55 • 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).

Other adverse events

Adverse event data not reported

Additional Information

Group Manager, Surgical, Alcon Japan

Alcon Japan Ltd.

Phone: 03-6899-5061

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