Clinical Investigation of a New Intraocular Lens

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

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 DiseaseIntervention/TreatmentPhase
  • 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

ArmIntervention/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

SiteCityStateCountryPostal Code
1Boozman-Hof Regional Eye ClinicRogersArkansasUnited States72756
2Empire Eye & Laser CenterBakersfieldCaliforniaUnited States93309
3Katzen Eye Care & Laser CenterBoynton BeachFloridaUnited States33426
4Cape Coral Eye CenterCape CoralFloridaUnited States33904
5Virdi Eye Clinic & Laser Vision CenterRock IslandIllinoisUnited States61201
6Eye Surgeons of IndianaIndianapolisIndianaUnited States46256
7Jones Eye ClinicSioux CityIowaUnited States51104
8Eye Doctors of WashingtonChevy ChaseMarylandUnited States20815
9Ophthalmic Consultants of Long IslandRockville CenterNew YorkUnited States11570
10The Eye Center of Central PAAllenwoodPennsylvaniaUnited States17810
11Scott & Christie and Associates, PCCranberry TownshipPennsylvaniaUnited States16066
12Loden Vision CenterGoodlettsvilleTennesseeUnited States37072
13Whitsett Vision GroupHoustonTexasUnited States77055
14Texas Eye and Laser CenterHurstTexasUnited States76054
15Lehmann Eye CenterNacogdochesTexasUnited States75965

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:

Study Results

Participant Flow

Recruitment DetailsBeginning 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 DetailA 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 TitleTECNIS Intraocular Lens, Model ZXR00TECNIS Intraocular Lens, Model ZCB00
Arm/Group DescriptionBilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
Period Title: Overall Study
STARTED148151
COMPLETED147148
NOT COMPLETED13

Baseline Characteristics

Arm/Group TitleTECNIS Intraocular Lens, Model ZXR00TECNIS Intraocular Lens, Model ZCB00Total
Arm/Group DescriptionBilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00Total of all reporting groups
Overall Participants148151299
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
TitleDistance Corrected Intermediate Visual Acuity
DescriptionFDA has requested co-primary endpoints of distance corrected and uncorrected intermediate visual acuity.
Time FrameAt 6 months

Outcome Measure Data

Analysis Population Description
Intent to Treat Population
Arm/Group TitleTECNIS Intraocular Lens, Model ZXR00TECNIS Intraocular Lens, Model ZCB00
Arm/Group DescriptionBilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
Measure Participants147148
Mean (Standard Error) [LogMAR]
0.105
(0.009)
0.343
(0.013)
2. Primary Outcome
TitleUncorrected Intermediate Visual Acuity
DescriptionUncorrected Intermediate Visual Acuity at 6 months.
Time Frame6 months

Outcome Measure Data

Analysis Population Description
Intent to Treat population
Arm/Group TitleTECNIS Intraocular Lens, Model ZXR00TECNIS Intraocular Lens, Model ZCB00
Arm/Group DescriptionBilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
Measure Participants147148
Mean (Standard Error) [LogMAR]
0.087
(0.009)
0.258
(0.014)

Adverse Events

Time Frame6 months
Adverse Event Reporting Description
Arm/Group TitleTECNIS Intraocular Lens, Model ZXR00TECNIS Intraocular Lens, Model ZCB00
Arm/Group DescriptionBilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
All Cause Mortality
TECNIS Intraocular Lens, Model ZXR00TECNIS Intraocular Lens, Model ZCB00
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total/ (NaN) / (NaN)
Serious Adverse Events
TECNIS Intraocular Lens, Model ZXR00TECNIS Intraocular Lens, Model ZCB00
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total5/148 (3.4%) 11/151 (7.3%)
Eye disorders
Cystoid Macular Edema2/148 (1.4%) 25/151 (3.3%) 5
Pupillary Capture1/148 (0.7%) 10/151 (0%) 0
Endophthalmitis1/148 (0.7%) 10/151 (0%) 0
Hypopyon1/148 (0.7%) 10/151 (0%) 0
Epiretinal Membrane Peel0/148 (0%) 01/151 (0.7%) 1
Anterior Ischemic Optic Neuropathy0/148 (0%) 01/151 (0.7%) 1
Lens Fragment0/148 (0%) 02/151 (1.3%) 2
Anterior Basement Membrane Distrophy0/148 (0%) 01/151 (0.7%) 1
Inflammation0/148 (0%) 01/151 (0.7%) 1
Other (Not Including Serious) Adverse Events
TECNIS Intraocular Lens, Model ZXR00TECNIS Intraocular Lens, Model ZCB00
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/148 (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.

Results Point of Contact

Name/TitleKendra Hileman, Ph.D., Director of Clinical Research and Development
OrganizationAbbott Medical Optics
Phone714-247-8613
Emailkendra.hileman@abbott.com
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