Clinical Investigation of a New Intraocular Lens

• Sponsor: Abbott Medical Optics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02203721
• Collaborator: (none)
• Enrollment: 324
• Locations: 15
• Arms: 2
• Duration (Months): 9
• Patients Per Site: 21.6
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

The purpose of this clinical trial is to evaluate the safety and effectiveness of the TECNIS Symfony Extended Range of Vision IOL.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: TECNIS Symfony Extended Range of Vision IOL, Model ZXR00; Device: TECNIS Monofocal IOL, Model ZCB00	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 324 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Clinical Investigation of the Tecnis Symfony Extended Range of Vision IOL, Model ZXR00
• Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TECNIS Symfony Extended Range of Vision IOL, Model ZXR00 Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00	Device: TECNIS Symfony Extended Range of Vision IOL, Model ZXR00
Active Comparator: TECNIS Monofocal IOL, Model ZCB00 Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00	Device: TECNIS Monofocal IOL, Model ZCB00

Outcome Measures

Primary Outcome Measures

1. Distance Corrected Intermediate Visual Acuity [At 6 months]

   FDA has requested co-primary endpoints of distance corrected and uncorrected intermediate visual acuity.

2. Uncorrected Intermediate Visual Acuity [6 months]

   Uncorrected Intermediate Visual Acuity at 6 months.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Minimum 22 years of age

• Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation have been planned for both eyes

• Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or worse with or without a glare source

• Potential for postoperative BCDVA of 20/30 Snellen or better

• Corneal astigmatism

• Clear intraocular media, other than cataract

• Availability, willingness and sufficient cognitive awareness to comply with examination procedures

• Signed informed consent and HIPAA authorization

• Ability to understand and respond to a questionnaire in English or Spanish

Exclusion Criteria:

• Requiring an intraocular lens power outside the available range of +16.0 D to +28.0 D

• Pupil abnormalities

• Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject

• Prior corneal refractive or intraocular surgery

• Corneal abnormalities

• Inability to achieve keratometric stability for contact lens wearers

• Subjects with diagnosed degenerative visual disorders that are predicted to cause visual acuity losses to a level of 20/30 Snellen or worse during the study

• Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as pseudoexfoliation, trauma, or posterior capsule defects

• Use of systemic or ocular medications that may affect vision

• Prior, current, or anticipated use during the course of the 6-month study of tamsulosin or silodosin, that may, in the opinion of the investigator, confound the outcome or increase the risk to the subject

• Inability to focus or fixate for prolonged periods of time

• Poorly-controlled diabetes

• Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcome(s) of the study.

• May be expected to require retinal laser treatment or other surgical intervention during the course of the study

• Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes

• Concurrent participation or participation within 30 days prior to preoperative visit in any other clinical trial

• Desire for monovision correction

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boozman-Hof Regional Eye Clinic	Rogers	Arkansas	United States	72756
2	Empire Eye & Laser Center	Bakersfield	California	United States	93309
3	Katzen Eye Care & Laser Center	Boynton Beach	Florida	United States	33426
4	Cape Coral Eye Center	Cape Coral	Florida	United States	33904
5	Virdi Eye Clinic & Laser Vision Center	Rock Island	Illinois	United States	61201
6	Eye Surgeons of Indiana	Indianapolis	Indiana	United States	46256
7	Jones Eye Clinic	Sioux City	Iowa	United States	51104
8	Eye Doctors of Washington	Chevy Chase	Maryland	United States	20815
9	Ophthalmic Consultants of Long Island	Rockville Center	New York	United States	11570
10	The Eye Center of Central PA	Allenwood	Pennsylvania	United States	17810
11	Scott & Christie and Associates, PC	Cranberry Township	Pennsylvania	United States	16066
12	Loden Vision Center	Goodlettsville	Tennessee	United States	37072
13	Whitsett Vision Group	Houston	Texas	United States	77055
14	Texas Eye and Laser Center	Hurst	Texas	United States	76054
15	Lehmann Eye Center	Nacogdoches	Texas	United States	75965

Sponsors and Collaborators

• Abbott Medical Optics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Optics
• ClinicalTrials.gov Identifier: NCT02203721
• Other Study ID Numbers: EROV-106-ZXRC
• First Posted: Jul 30, 2014
• Last Update Posted: Jan 11, 2017
• Last Verified: Nov 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Cataract

Study Results

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 Detail	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

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 Participants	148	151	299
Age (Count of Participants)
<=18 years	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 (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	68.0 (7.5)	67.9 (7.9)	67.9 (7.7)
Gender (Count of Participants)
Female	91 61.5%	86 57%	177 59.2%
Male	57 38.5%	65 43%	122 40.8%
Region of Enrollment (participants) [Number]
United States	148 100%	151 100%	299 100%

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
Measure Participants	147	148
Mean (Standard Error) [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
Measure Participants	147	148
Mean (Standard Error) [LogMAR]	0.087 (0.009)	0.258 (0.014)

Adverse Events

Time Frame	6 months
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	TECNIS Intraocular Lens, Model ZXR00		TECNIS Intraocular Lens, Model ZCB00
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/148 (3.4%)		11/151 (7.3%)
Eye disorders
Cystoid Macular Edema	2/148 (1.4%)	2	5/151 (3.3%)	5
Pupillary Capture	1/148 (0.7%)	1	0/151 (0%)	0
Endophthalmitis	1/148 (0.7%)	1	0/151 (0%)	0
Hypopyon	1/148 (0.7%)	1	0/151 (0%)	0
Epiretinal Membrane Peel	0/148 (0%)	0	1/151 (0.7%)	1
Anterior Ischemic Optic Neuropathy	0/148 (0%)	0	1/151 (0.7%)	1
Lens Fragment	0/148 (0%)	0	2/151 (1.3%)	2
Anterior Basement Membrane Distrophy	0/148 (0%)	0	1/151 (0.7%)	1
Inflammation	0/148 (0%)	0	1/151 (0.7%)	1
Other (Not Including Serious) Adverse Events
	TECNIS Intraocular Lens, Model ZXR00		TECNIS Intraocular Lens, Model ZCB00
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/148 (0%)		0/151 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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.