Clinical Investigation of a New Intraocular Lens

• ClinicalTrials.gov Identifier: NCT02203721
• Recruitment Status: Completed
• First Posted: July 30, 2014
• Results First Posted: January 11, 2017
• Last Update Posted: January 11, 2017
• Sponsor: Abbott Medical Optics
• Information provided by (Responsible Party): Abbott Medical Optics

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Cataract
• Interventions: Device: TECNIS Symfony Extended Range of Vision IOL, Model ZXR00; Device: TECNIS Monofocal IOL, Model ZCB00
• Enrollment: 324

Participant Flow

Recruitment Details	Beginning August 27, 2014, a total of 324 subjects were enrolled (consented) in the study and 299 of these subjects were implanted with a study lens in at least one operative eye between September 16, 2014, and February 10, 2015, across 15 U.S. clinical sites.
Pre-assignment Details	A total of 23 subjects were consented but were not assigned to a group due to failure to meet inclusion/exclusion criteria, withdrawn consent, non-ocular health, or lost-to-follow-up.

Arm/Group Title	TECNIS Intraocular Lens, Model ZXR00	TECNIS Intraocular Lens, Model ZCB00
Arm/Group Description	Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00	Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
Period Title: Overall Study
Started	148	151
Completed	147	148
Not Completed	1	3
Reason Not Completed
Lost to Follow-up	1	0
Death	0	2
Illness	0	1

Baseline Characteristics

Arm/Group Title		TECNIS Intraocular Lens, Model ZXR00	TECNIS Intraocular Lens, Model ZCB00	Total
Arm/Group Description		Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00	Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00	Total of all reporting groups
Overall Number of Baseline Participants		148	151	299
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	148 participants	151 participants	299 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	85 57.4%	85 56.3%	170 56.9%
	>=65 years	63 42.6%	66 43.7%	129 43.1%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	148 participants	151 participants	299 participants
		68.0 (7.5)	67.9 (7.9)	67.9 (7.7)
Gender; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	148 participants	151 participants	299 participants
	Female	91 61.5%	86 57.0%	177 59.2%
	Male	57 38.5%	65 43.0%	122 40.8%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	148 participants	151 participants	299 participants
		148	151	299

Outcome Measures

1. Primary Outcome

Title	Distance Corrected Intermediate Visual Acuity
Description	FDA has requested co-primary endpoints of distance corrected and uncorrected intermediate visual acuity.
Time Frame	At 6 months

Outcome Measure Data

Analysis Population Description

Intent to Treat Population

Arm/Group Title	TECNIS Intraocular Lens, Model ZXR00	TECNIS Intraocular Lens, Model ZCB00
Arm/Group Description:	Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00	Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
Overall Number of Participants Analyzed	147	148
Mean (Standard Error); Unit of Measure: LogMAR
	0.105 (0.009)	0.343 (0.013)

2. Primary Outcome

Title	Uncorrected Intermediate Visual Acuity
Description	Uncorrected Intermediate Visual Acuity at 6 months.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Intent to Treat population

Arm/Group Title	TECNIS Intraocular Lens, Model ZXR00	TECNIS Intraocular Lens, Model ZCB00
Arm/Group Description:	Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00	Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
Overall Number of Participants Analyzed	147	148
Mean (Standard Error); Unit of Measure: LogMAR
	0.087 (0.009)	0.258 (0.014)

Adverse Events

Time Frame	6 months
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	TECNIS Intraocular Lens, Model ZXR00		TECNIS Intraocular Lens, Model ZCB00
Arm/Group Description	Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00		Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
All-Cause Mortality
	TECNIS Intraocular Lens, Model ZXR00		TECNIS Intraocular Lens, Model ZCB00
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events
	TECNIS Intraocular Lens, Model ZXR00		TECNIS Intraocular Lens, Model ZCB00
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/148 (3.38%)		11/151 (7.28%)
Eye disorders
Cystoid Macular Edema † 1	2/148 (1.35%)	2	5/151 (3.31%)	5
Pupillary Capture † 1	1/148 (0.68%)	1	0/151 (0.00%)	0
Endophthalmitis † 1	1/148 (0.68%)	1	0/151 (0.00%)	0
Hypopyon † 1	1/148 (0.68%)	1	0/151 (0.00%)	0
Epiretinal Membrane Peel † 1	0/148 (0.00%)	0	1/151 (0.66%)	1
Anterior Ischemic Optic Neuropathy † 1	0/148 (0.00%)	0	1/151 (0.66%)	1
Lens Fragment † 1 [1]	0/148 (0.00%)	0	2/151 (1.32%)	2
Anterior Basement Membrane Distrophy † 1	0/148 (0.00%)	0	1/151 (0.66%)	1
Inflammation † 1 [2]	0/148 (0.00%)	0	1/151 (0.66%)	1
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA (17.0); [1] Requiring fragment removal; [2] Requiring treatment injection
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	TECNIS Intraocular Lens, Model ZXR00		TECNIS Intraocular Lens, Model ZCB00
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/148 (0.00%)		0/151 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results.

Results Point of Contact

• Name/Title: Kendra Hileman, Ph.D., Director of Clinical Research and Development
• Organization: Abbott Medical Optics
• Phone: 714-247-8613
• EMail: kendra.hileman@abbott.com

• Responsible Party: Abbott Medical Optics
• ClinicalTrials.gov Identifier: NCT02203721
• Other Study ID Numbers: EROV-106-ZXRC
• First Submitted: July 24, 2014
• First Posted: July 30, 2014
• Results First Submitted: September 28, 2016
• Results First Posted: January 11, 2017
• Last Update Posted: January 11, 2017