Clinical Investigation of Corneal Incision Size After Intraocular Lens (IOL) Implantation

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02826421
• Collaborator: (none)
• Enrollment: 114
• Arms: 4
• Actual Duration (Months): 4.9

Study Details

Study Description

Brief Summary

The purpose of this study is to compare corneal incision size after IOL implantation with the use of one of four IOL delivery systems (three preloaded IOL delivery systems and one manually loaded IOL delivery system).

Condition or Disease	Intervention/Treatment	Phase
Cataracts	Device: UltraSert Preloaded Delivery System; Device: iTec Preloaded Delivery System; Device: iSert Preloaded Delivery System; Device: Monarch III D Manual IOL Delivery System	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 114 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Clinical Investigation of Corneal Incision Size After IOL Implantation With Preloaded Delivery Devices and a Manual Delivery Device
• Actual Study Start Date: Jul 4, 2016
• Actual Primary Completion Date: Nov 29, 2016
• Actual Study Completion Date: Nov 29, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: UltraSert Preloaded Delivery System Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery	Device: UltraSert Preloaded Delivery System; Includes AcrySof IQ monofocal posterior chamber IOL Model AU00T0, intended for long term use over the lifetime of the subject
Active Comparator: iTec Preloaded Delivery System Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery	Device: iTec Preloaded Delivery System; Includes TECNIS 1-piece monofocal IOL, intended for long term use over the lifetime of the subject
Active Comparator: iSert Preloaded Delivery System Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery	Device: iSert Preloaded Delivery System; Includes Model 251 or Model 250 posterior chamber IOL, as selected by the Investigator, intended for long term use over the lifetime of the subject
Active Comparator: Monarch III D Manual IOL Delivery System Manually loaded IOL delivered via a 2.4 mm clear corneal incision during cataract surgery	Device: Monarch III D Manual IOL Delivery System; Includes AcrySof IQ monofocal IOL posterior chamber IOL Model SN60WF, intended for long term use over the lifetime of the subject

Outcome Measures

Primary Outcome Measures

1. Mean Corneal Incision Size After IOL Implantation (UltraSert, iTec, and iSert) [Day 0, operative day]

   Post-IOL implantation corneal incision size was measured directly after IOL implantation and reported in millimeters (mm). Minimizing enlargement of incision size during cataract surgery results in less postoperative inflammation, less surgically-induced astigmatism, and more rapid visual and wound rehabilitation. This endpoint was prespecified for the UltraSert, iTec, and iSert preloaded delivery systems. Only one eye (study eye) contributed to the analysis.

Secondary Outcome Measures

1. Mean Corneal Incision Size After IOL Implantation (UltraSert and Monarch III D) [Day 0, operative day]

   Post-IOL implantation corneal incision size was measured directly after IOL implantation and reported in millimeters (mm). Minimizing enlargement of incision size during cataract surgery results in less postoperative inflammation, less surgically-induced astigmatism, and more rapid visual and wound rehabilitation. This endpoint was prespecified for the UltraSert preloaded delivery system and the Monarch III D delivery system. Only one eye (study eye) contributed to the analysis.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Able to comprehend and sign a statement of informed consent;

• Willing and able to complete all required postoperative visits;

• Cataract;

• Planned cataract removal by phacoemulsification;

• Calculated lens power from 18.0 through 27.0 D inclusive;

• Preoperative astigmatism <1.0D;

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Systemic disease that affects the cornea;

• Any inflammation or edema of the cornea;

• Previous or planned refractive or corneal surgery during the subject's participation in the study;

• Previous corneal transplant;

• Previous retinal detachment;

• Pregnancy or lactation, current or planned, during the course of the study;

• Current participation in another investigational drug or device study that may confound the results of this investigation;

• Any condition observed before or during surgery that in the surgeon's medical opinion may affect the success of the cataract surgery;

• Other protocol-specified exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Sr. Clinical Manager, GCRA, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT02826421
• Other Study ID Numbers: ILN296-P001
• First Posted: Jul 11, 2016
• Last Update Posted: Jul 2, 2018
• Last Verified: Jul 1, 2017

• 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
• Keywords provided by Alcon Research: Intraocular lens
• Additional relevant MeSH terms: Cataract

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 4 study centers located in Spain and 2 study centers located in France.
Pre-assignment Detail	Of the 114 enrolled, 2 subjects did not meet inclusion/exclusion criteria, and 3 subjects were excluded prior to randomization for "other" reasons (ie, the maximum number of randomized subjects was reached). This reporting group includes all randomized subjects (109).

Arm/Group Title	UltraSert	iTec	iSert	Monarch III D
Arm/Group Description	Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery	Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery	Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery	Manually loaded IOL delivered via a 2.4 mm clear corneal incision during cataract surgery
Period Title: Overall Study
STARTED	22	29	28	30
Treated	19	26	26	28
COMPLETED	19	26	26	28
NOT COMPLETED	3	3	2	2

Baseline Characteristics

Arm/Group Title	UltraSert	iTec	iSert	Monarch III D	Total
Arm/Group Description	Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery	Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery	Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery	Manually loaded IOL delivered via a 2.4 mm clear corneal incision during cataract surgery	Total of all reporting groups
Overall Participants	19	26	26	28	99
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	71.4 (8.71)	70.7 (8.31)	73.0 (7.27)	72.5 (7.10)	71.9 (7.73)
Sex: Female, Male (Count of Participants)
Female	14 73.7%	13 50%	14 53.8%	17 60.7%	58 58.6%
Male	5 26.3%	13 50%	12 46.2%	11 39.3%	41 41.4%

Outcome Measures

1. Primary Outcome

Title	Mean Corneal Incision Size After IOL Implantation (UltraSert, iTec, and iSert)
Description	Post-IOL implantation corneal incision size was measured directly after IOL implantation and reported in millimeters (mm). Minimizing enlargement of incision size during cataract surgery results in less postoperative inflammation, less surgically-induced astigmatism, and more rapid visual and wound rehabilitation. This endpoint was prespecified for the UltraSert, iTec, and iSert preloaded delivery systems. Only one eye (study eye) contributed to the analysis.
Time Frame	Day 0, operative day

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	UltraSert	iTec	iSert
Arm/Group Description	Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery	Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery	Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
Measure Participants	19	26	26
Mean (Standard Error) [mm]	2.35 (0.019)	2.47 (0.016)	2.54 (0.019)

2. Secondary Outcome

Title	Mean Corneal Incision Size After IOL Implantation (UltraSert and Monarch III D)
Description	Post-IOL implantation corneal incision size was measured directly after IOL implantation and reported in millimeters (mm). Minimizing enlargement of incision size during cataract surgery results in less postoperative inflammation, less surgically-induced astigmatism, and more rapid visual and wound rehabilitation. This endpoint was prespecified for the UltraSert preloaded delivery system and the Monarch III D delivery system. Only one eye (study eye) contributed to the analysis.
Time Frame	Day 0, operative day

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	UltraSert	Monarch III D
Arm/Group Description	Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery	Manually loaded IOL delivered via a 2.4 mm clear corneal incision during cataract surgery
Measure Participants	19	28
Mean (Standard Error) [mm]	2.35 (0.019)	2.49 (0.011)

Adverse Events

Time Frame	Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 31 days). AEs are reported as pretreatment and treatment-emergent.
Adverse Event Reporting Description	An AE 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 medical device. Ocular adverse events are presented for both study eye and non-study eye combined.
Arm/Group Title	Pretreatment		UltraSert		iTec		iSert		Monarch III D
Arm/Group Description	All subjects who consented to participate in the study prior to initiation of study treatment		All subjects treated with UltraSert		All subjects treated with iTec		All subjects treated with iSert		All subjects treated with Monarch III D
All Cause Mortality
	Pretreatment		UltraSert		iTec		iSert		Monarch III D
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/114 (0%)		0/19 (0%)		0/26 (0%)		0/26 (0%)		0/28 (0%)
Serious Adverse Events
	Pretreatment		UltraSert		iTec		iSert		Monarch III D
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/114 (0.9%)		0/19 (0%)		1/26 (3.8%)		0/26 (0%)		0/28 (0%)
Infections and infestations
Gastroenteritis	1/114 (0.9%)		0/19 (0%)		0/26 (0%)		0/26 (0%)		0/28 (0%)
Injury, poisoning and procedural complications
Cataract operation complication	0/114 (0%)		0/19 (0%)		1/26 (3.8%)		0/26 (0%)		0/28 (0%)
Surgical procedure repeated	0/114 (0%)		0/19 (0%)		1/26 (3.8%)		0/26 (0%)		0/28 (0%)
Other (Not Including Serious) Adverse Events
	Pretreatment		UltraSert		iTec		iSert		Monarch III D
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/114 (0%)		0/19 (0%)		0/26 (0%)		0/26 (0%)		0/28 (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.