Clinical Evaluation of FLACS With Combination of LenSx® and Centurion®

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03479944
• Collaborator: (none)
• Enrollment: 57
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.8
• Patients Per Site Per Month: 6.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Procedure: FLACS; Procedure: Manual conventional surgery; Device: CENTURION® Vision System; Device: LenSx®	N/A

Detailed Description

Subjects will attend 7 scheduled visits: 1 pre-operative, 1 operative, and 5 post-operative.

Study Design

• Study Type: Interventional
• Actual Enrollment: 57 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of FLACS (Femtosecond Laser Assisted Cataract Surgery) With Combination of LenSx® and Centurion®
• Actual Study Start Date: Aug 22, 2018
• Actual Primary Completion Date: Nov 19, 2018
• Actual Study Completion Date: May 17, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FLACS Femtosecond laser assisted cataract surgery (FLACS) in 1 eye, with manual conventional surgery in the fellow eye, as randomized	Procedure: FLACS; Femtosecond laser assisted cataract surgery consisting of LenSx® and Centurion® combination; Device: CENTURION® Vision System; Phacoemulsification aspiration platform for use during cataract surgery; Device: LenSx®; Femtosecond laser system used for continuous curvilinear capsulorhexis (CCC) and lens fragmentation during cataract surgery
Active Comparator: Conventional Manual conventional surgery in 1 eye, with FLACS in the fellow eye, as randomized	Procedure: Manual conventional surgery; Removal of cataractous lens by phacoemulsification; Device: CENTURION® Vision System; Phacoemulsification aspiration platform for use during cataract surgery

Outcome Measures

Primary Outcome Measures

1. Cumulative Dissipated Energy (CDE) [Day 0 (operative day)]

   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.

Secondary Outcome Measures

1. Percent Change of Corneal Endothelial Cell Density (ECD) at Visit 5 (150-210 Days After Surgery) From Pre-Operative Visit [Preoperative, Day 150-210 (post-operative)]

   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.

2. Percentage of Average Torsional Amplitude [Day 0 (operative day)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Cataracts (Grade 2-4 of Emery-Little Classification) with planned cataract removal by phacoemulsification in both eyes;

• Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures;

• Calculated lens power within the available range;

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Any pathology that could reduce visual potential;

• Hypotony or the presence of a corneal implant;

• Residual, recurrent, active ocular or eyelid disease;

• Poorly dilating pupil;

• Any contraindication to cataract;

• Eyes with two different levels of cataract grade;

• Pregnant, or planned pregnancy during the study;

• Expected to require an ocular surgical treatment at any time during the study;

• Other protocol-specified exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alcon Investigative Site	Iizuka City	Fukuoka	Japan	820-0067

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Alcon, A Novartis Division, Alcon, A Novartis Division

Study Documents (Full-Text)

• Study Protocol - May 18, 2018
• Statistical Analysis Plan - Dec 5, 2018

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT03479944
• Other Study ID Numbers: CTB258-P001
• First Posted: Mar 27, 2018
• Last Update Posted: Dec 16, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Cataract

Study Results

Participant Flow

Pre-assignment Detail	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)

Arm/Group Title	All Study Subjects
Arm/Group Description	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.
Period Title: Overall Study
STARTED	55
FLACS	55
Conventional	55
Full Analysis Set	53
COMPLETED	55
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	All Study Subjects
Arm/Group Description	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 Participants	55
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	73.2 (6.6)
Age, Customized (years) [Number]
Less than 60	0
60-69	15
70-79	30
80 and greater	10
Sex: Female, Male (Count of Participants)
Female	35 63.6%
Male	20 36.4%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
Japan	55 100%

Outcome Measures

1. Primary Outcome

Title	Cumulative Dissipated Energy (CDE)
Description	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.
Time Frame	Day 0 (operative day)

Outcome Measure Data

Analysis Population Description

All eyes with successful cataract surgery for which anterior capsulotomy and lens fragmentation have been completed using the assigned surgical techniques (Full Analysis Set).

Arm/Group Title	FLACS	Conventional
Arm/Group Description	Femtosecond laser assisted cataract surgery (FLACS) with LenSx® and Centurion® Vision System in combination	Manual cataract surgery with Centurion® Vision System
Measure Participants	53	53
Measure eyes	53	53
Mean (Standard Deviation) [unitless]	0.213 (0.334)	1.718 (0.898)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	FLACS, Conventional
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test based on MMRM
	Comments	MMRM: Mixed Model for Repeated Measures
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-1.505
	Confidence Interval	(2-Sided) 95%; -1.720 to -1.289
	Parameter Dispersion	Type: Value:
	Estimation Comments	Least Squares Mean Difference from a Mixed Model for Repeated Measures

2. Secondary Outcome

Title	Percent Change of Corneal Endothelial Cell Density (ECD) at Visit 5 (150-210 Days After Surgery) From Pre-Operative Visit
Description	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.
Time Frame	Preoperative, Day 150-210 (post-operative)

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	FLACS	Conventional
Arm/Group Description	Femtosecond laser assisted cataract surgery with LenSx® and Centurion® Vision System in combination	Manual cataract surgery with Centurion® Vision System
Measure Participants	53	53
Measure eyes	53	53
Mean (Standard Deviation) [percent change]	-1.5 (5.6)	-2.7 (5.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	FLACS, Conventional
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.2602
	Comments
	Method	t-test based on MMRM
	Comments	MMRM: Mixed Model for Repeated Measures
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.2
	Confidence Interval	(2-Sided) 95%; -0.9 to 3.3
	Parameter Dispersion	Type: Value:
	Estimation Comments	Least Squares Mean Difference from a Mixed Model for Repeated Measures

3. Secondary Outcome

Title	Percentage of Average Torsional Amplitude
Description	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.
Time Frame	Day 0 (operative day)

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	FLACS	Conventional
Arm/Group Description	Femtosecond laser assisted cataract surgery with LenSx® and Centurion® Vision System in combination	Manual cataract surgery with Centurion® Vision System
Measure Participants	53	53
Measure eyes	53	53
Mean (Standard Deviation) [percentage of avg torsional amplitude]	19.57 (16.02)	31.09 (6.56)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	FLACS, Conventional
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-11.52
	Confidence Interval	(2-Sided) 95%; -15.87 to -7.18
	Parameter Dispersion	Type: Value:
	Estimation Comments	Least Squares Mean Difference from a Mixed Model for Repeated Measures

Adverse Events

Time Frame	Adverse events were collected from the time of initial treatment through study conclusion, for an average individual duration of 150 to 120 days.
Adverse Event Reporting Description	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).
Arm/Group Title	Ocular Adverse Events - FLACS		Ocular Adverse Events - Conventional		Non-Ocular Adverse Events
Arm/Group Description	All subjects/eyes for which cataract surgery was performed with FLACS (regardless of success or failure)		All subjects/eyes for which cataract surgery was performed with Conventional technique (regardless of success or failure)		All subjects for which cataract surgery was performed (regardless of success or failure)
All Cause Mortality
	Ocular Adverse Events - FLACS		Ocular Adverse Events - Conventional		Non-Ocular Adverse Events
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/55 (0%)		0/55 (0%)
Serious Adverse Events
	Ocular Adverse Events - FLACS		Ocular Adverse Events - Conventional		Non-Ocular Adverse Events
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/55 (0%)		2/55 (3.6%)
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate	0/55 (0%)		0/55 (0%)		1/55 (1.8%)
Nervous system disorders
Epilepsy	0/55 (0%)		0/55 (0%)		1/55 (1.8%)
Other (Not Including Serious) Adverse Events
	Ocular Adverse Events - FLACS		Ocular Adverse Events - Conventional		Non-Ocular Adverse Events
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/55 (0%)		0/55 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Sponsor reserves the right of prior review of any publication or presentation of information related to the study.