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

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02502526
• Collaborator: (none)
• Enrollment: 231
• Arms: 3
• Actual Duration (Months): 28.2

Study Details

Study Description

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)].

Condition or Disease	Intervention/Treatment	Phase
Cataracts	Device: Centurion® Vision System, 45° Balanced Tip; Device: Centurion® Vision System, 45° MFK Tip; Device: lnfiniti® Vision System, 45° MFK Tip; Device: INTREPID® Ultra infusion sleeve; Device: Ultra infusion sleeve	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 231 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Comparison of Cumulative Dissipated Energy (CDE) and Balanced Salt Solution (BSS) Fluid Used With the Centurion® With the 45° Degree Balanced Ultrasound (U/S) Tip vs the Centurion® With Mini Flared Kelman U/S Tip vs the Infiniti® With Mini Flared Kelman U/S Tip on Hard Lenses
• Actual Study Start Date: Jul 27, 2015
• Actual Primary Completion Date: Mar 23, 2017
• Actual Study Completion Date: Nov 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CVS with 45° Balanced Tip 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	Device: Centurion® Vision System, 45° Balanced Tip; Other Names: CVS with 45° Balanced Tip ; Device: INTREPID® Ultra infusion sleeve
Active Comparator: CVS with 45° MFK Tip 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	Device: Centurion® Vision System, 45° MFK Tip; Other Names: CVS with 45° MFK Tip ; Device: INTREPID® Ultra infusion sleeve
Active Comparator: IVS with 45° MFK Tip 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	Device: lnfiniti® Vision System, 45° MFK Tip; Other Names: IVS with 45° MFK Tip ; Device: Ultra infusion sleeve

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts 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 exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

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

Study Documents (Full-Text)

• Study Protocol - Jul 18, 2016
• Statistical Analysis Plan - Aug 29, 2017

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT02502526
• Other Study ID Numbers: CTU424-P001
• First Posted: Jul 20, 2015
• Last Update Posted: Jul 2, 2018
• Last Verified: Apr 1, 2018

• Additional relevant MeSH terms: Cataract

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 4 study centers located in the United States (2), Hungary (1), and India (1).
Pre-assignment Detail	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).

Arm/Group Title	CVS Bal	CVS MFK	IVS MFK
Arm/Group Description	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, 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	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
Period Title: Overall Study
STARTED	62	59	61
Intent-to-Treat (ITT)	57	57	59
COMPLETED	56	55	55
NOT COMPLETED	6	4	6

Baseline Characteristics

Arm/Group Title	CVS Bal	CVS MFK	IVS MFK	Total
Arm/Group Description	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, 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, 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 of all reporting groups
Overall Participants	57	57	59	173
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69.6 (8.4)	70.3 (9.2)	73.4 (9.6)	71.1 (9.2)
Sex: Female, Male (Count of Participants)
Female	30 52.6%	32 56.1%	36 61%	98 56.6%
Male	27 47.4%	25 43.9%	23 39%	75 43.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	28 49.1%	31 54.4%	30 50.8%	89 51.4%
Not Hispanic or Latino	29 50.9%	26 45.6%	29 49.2%	84 48.6%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Cumulative Dissipated Energy (CDE)
Description	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)

Outcome Measure Data

Analysis Population Description

ITT with non-missing data

Arm/Group Title	CVS Bal	IVS MFK
Arm/Group Description	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	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
Measure Participants	57	58
Mean (Standard Deviation) [percent-seconds]	6.2 (2.9)	11.4 (8.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CVS Bal, IVS MFK
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments
	Method	ANCOVA
	Comments

2. Secondary Outcome

Title	Cumulative Dissipated Energy (CDE)
Description	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)

Outcome Measure Data

Analysis Population Description

ITT with non-missing data

Arm/Group Title	CVS Bal	CVS MFK	IVS MFK
Arm/Group Description	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, 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, 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
Measure Participants	57	57	58
Mean (Standard Deviation) [percent-seconds]	6.2 (2.9)	11.6 (7.3)	11.4 (8.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CVS Bal, IVS MFK
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	IVS MFK, IVS MFK
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.605
	Comments
	Method	ANCOVA
	Comments

3. Secondary Outcome

Title	Balanced Salt Solution (BSS) Fluid Used
Description	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)

Outcome Measure Data

Analysis Population Description

ITT with non-missing data

Arm/Group Title	CVS Bal	CVS MFK	IVS MFK
Arm/Group Description	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, 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, 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
Measure Participants	57	57	58
Mean (Standard Deviation) [milliliters (ml)]	95.8 (33.1)	101.7 (34.3)	94.1 (34.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CVS Bal, IVS MFK
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.520
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	IVS MFK, IVS MFK
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.817
	Comments
	Method	ANCOVA
	Comments

Adverse Events

Time Frame	Surgery through planned study completion, an average of 3 months
Adverse Event Reporting Description	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).
Arm/Group Title	CVS Bal		CVS MFK		IVS MFK
Arm/Group Description	Subjects exposed to CVS, 45° Balanced Tip		Subjects exposed to CVS, 45° MFK Tip		Subjects exposed to lVS, 45° MFK Tip
All Cause Mortality
	CVS Bal		CVS MFK		IVS MFK
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/57 (0%)		0/57 (0%)		0/59 (0%)
Serious Adverse Events
	CVS Bal		CVS MFK		IVS MFK
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/57 (1.8%)		0/57 (0%)		3/59 (5.1%)
Eye disorders
Posterior capsule rupture	1/57 (1.8%)		0/57 (0%)		0/59 (0%)
Vitreous loss	1/57 (1.8%)		0/57 (0%)		0/59 (0%)
Injury, poisoning and procedural complications
Subdural haematoma	0/57 (0%)		0/57 (0%)		1/59 (1.7%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic	0/57 (0%)		0/57 (0%)		1/59 (1.7%)
Surgical and medical procedures
Vitrectomy	1/57 (1.8%)		0/57 (0%)		0/59 (0%)
Vascular disorders
Hypertensive crisis	0/57 (0%)		0/57 (0%)		1/59 (1.7%)
Other (Not Including Serious) Adverse Events
	CVS Bal		CVS MFK		IVS MFK
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/57 (24.6%)		17/57 (29.8%)		11/59 (18.6%)
Eye disorders
Corneal endothelial cell loss	14/57 (24.6%)		17/57 (29.8%)		11/59 (18.6%)

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.