Post-Approval Study of the Tecnis® Toric IOL

Sponsor
Abbott Medical Optics (Industry)
Overall Status
Completed
CT.gov ID
NCT02566083
Collaborator
(none)
365
Enrollment
44
Locations
2
Arms
43
Actual Duration (Months)
8.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a prospective, multicenter, bilateral, non-randomized, open-label, comparative clinical study conducted at up to 80 sites in the USA. Subjects will choose to be bilaterally implanted with either 1) the TECNIS 1-Piece Toric IOLs, Model ZCT300 and/or ZCT400, or 2) the TECNIS Monofocal Model ZCB00 non-toric control IOL, according to subject preference

Condition or DiseaseIntervention/TreatmentPhase
  • Device: non-toric intraocular lens
  • Device: toric intraocular lens
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
365 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Post-Approval Study of the Tecnis® Toric IOL, Models ZCT300 and ZCT400
Actual Study Start Date :
Oct 21, 2015
Actual Primary Completion Date :
Dec 11, 2018
Actual Study Completion Date :
May 23, 2019

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: non-toric intraocular lens

non-toric approved intraocular lens

Device: non-toric intraocular lens
TECNIS One-piece Monofocal Model ZCB00

Active Comparator: toric intraocular lens

approved toric intraocular lens

Device: toric intraocular lens
TECNIS One-piece Toric Models ZCT300 or ZCT400

Outcome Measures

Primary Outcome Measures

  1. Rate of Severe Visual Distortions [6 months]

    The rate of severe visual distortions under overall circumstances for the five visual distortion items of interest (lines that slant, tilt, split or separate; flat surfaces appearing curved; objects appearing further away or closer than they are; objects appearing to have a different size or shape; and physical discomfort related to vision). The six month data were used for this endpoint if available and if not an earlier visit was used. If a subject had a lens repositioning the questionnaire prior to the repositioning was used if available.

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Minimum 22 years of age

  • Bilateral cataracts

  • Preoperative keratometric cylinder in both eyes

  • Most appropriate toric IOL model choice (ZCT300 or ZCT400)

  • Predicted residual refractive cylinder, based on the AMO Toric IOL Calculator, must be:

≤ 0.69 D for a ZCT300 IOL or ≤ 0.88 D for a ZCT400 IOL

  • Clear intraocular media other than cataract in each eye

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

  • Ability to understand, read and write English in order to consent to study participation and complete a study questionnaire

  • Signed informed consent and HIPAA authorization

Exclusion Criteria:
  • Irregular corneal astigmatism

  • Any corneal pathology/abnormality other than regular corneal astigmatism

  • Previous corneal surgery

  • Recent ocular trauma or intraocular surgery that is not resolved/stable or may affect visual outcomes

  • Any pupil abnormalities

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

  • Known ocular disease or pathology that may affect visual acuity or that may require surgical intervention during the course of the study

  • Concurrent participation or participation during 30 days prior to preoperative visit in any other clinical study

  • Planned monovision correction

  • 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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Eye Center SouthDothanAlabamaUnited States36301
2Arizona Eye CenteChandlerArizonaUnited States85225
3Fishkind, Bakewell & Maltzman Eye Care & Surgery CenteTucsonArizonaUnited States85704
4Boozman-Hof Regional Eye ClinicRogersArkansasUnited States72757
5Empire Eye & Laser CenterBakersfieldCaliforniaUnited States93309
6Atlantis Eye CareHuntington BeachCaliforniaUnited States92647
7Scripps Clinic Medical GroupLa JollaCaliforniaUnited States92037
8Southern California Eye Physicians & AssociatesLong BeachCaliforniaUnited States90805
9Feinerman Vision CenterNewport BeachCaliforniaUnited States92663
10Coastal VisionOrangeCaliforniaUnited States92868
11California Eye Medical SpecialistsPasadenaCaliforniaUnited States91107
12Wolstan & Goldberg Eye AssociatesTorranceCaliforniaUnited States90505
13Florida Eye Microsurgical Institute, Inc.Boynton BeachFloridaUnited States33426
14Katzen Eye Care & Laser CenterBoynton BeachFloridaUnited States33426
15The Eye AssociatesBradentonFloridaUnited States34209
16Cape Coral Eye CenterCape CoralFloridaUnited States336904
17Levenson Eye Associates, Inc.JacksonvilleFloridaUnited States32204
18Northwestern University Feinberg School of MedicineChicagoIllinoisUnited States60611
19Virdi Eye Clinic & Laser Vision CenterRock IslandIllinoisUnited States61201
20Senior Health ServicesLouisvilleKentuckyUnited States40220
21Chesapeake Eye Care and Laser CenterAnnapolisMarylandUnited States21401
22Solomon Eye AssociatesBowieMarylandUnited States20716
23Eye Doctors of WashingtonChevy ChaseMarylandUnited States20815
24Oakland Ophthalmic Surgery, P.C.BirminghamMichiganUnited States48009
25TLC Eye Care and Laser CentersChelseaMichiganUnited States48118
26Ophthalmology AssociatesSaint LouisMissouriUnited States63131
27Ophthalmology ConsultantsSaint LouisMissouriUnited States63131
28Mercy Clinic Eye SpecialistSpringfieldMissouriUnited States65804
29Kindermann Eye AssociatesCherry HillNew JerseyUnited States08002
30Matossian Eye AssociatesPenningtonNew JerseyUnited States08534
31Eye Associates of New MexicoAlbuquerqueNew MexicoUnited States87109
32Pamel Vision & Laser GroupNew YorkNew YorkUnited States10065
33Fine, Hoffman & SimsEugeneOregonUnited States97401
34The Eye Center of Central PAAllenwoodPennsylvaniaUnited States17810
35Ludwick Eye CenterChambersburgPennsylvaniaUnited States17201
36Scott & Christie and Associates, PCCranberry TownshipPennsylvaniaUnited States16066
37Carolina Cataract & Laser CenterLadsonSouth CarolinaUnited States29456
38Vance Thompson VisionSioux FallsSouth DakotaUnited States57105
39Loden Vision CentersGoodlettsvilleTennesseeUnited States37072
40Houston Eye AssociatesHoustonTexasUnited States77025
41Whitsett Vision GroupHoustonTexasUnited States77055
42Focal Point VisionSan AntonioTexasUnited States78229
43San Antonio Eye SpecialistsSan AntonioTexasUnited States78248
44Clarus Eye CentreLaceyWashingtonUnited States98503

Sponsors and Collaborators

  • Abbott Medical Optics

Investigators

  • Study Director: Devi Priya Janakiraman, OD, FAAO, Johnson & Johnson Surgical Vision

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT02566083
Other Study ID Numbers:
  • TIOL-202-TPAS
First Posted:
Oct 1, 2015
Last Update Posted:
Jan 18, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleToric IOLNon-toric IOL
Arm/Group DescriptionExperimental (ZCT300, ZCT400)Control (ZCB00)
Period Title: Overall Study
STARTED214151
COMPLETED198141
NOT COMPLETED1610

Baseline Characteristics

Arm/Group TitleToric IOLNon-toric IOLTotal
Arm/Group DescriptionExperimental (ZCT300, ZCT400)Control (ZCB00)Total of all reporting groups
Overall Participants214151365
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
69.3
(9.6)
69.7
(10.0)
69.5
(9.75)
Sex: Female, Male (Count of Participants)
Female
120
56.1%
82
54.3%
202
55.3%
Male
94
43.9%
69
45.7%
163
44.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
19
8.9%
10
6.6%
29
7.9%
Not Hispanic or Latino
195
91.1%
141
93.4%
336
92.1%
Unknown or Not Reported
0
0%
0
0%
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
1
0.7%
1
0.3%
Asian
6
2.8%
4
2.6%
10
2.7%
Native Hawaiian or Other Pacific Islander
1
0.5%
0
0%
1
0.3%
Black or African American
10
4.7%
18
11.9%
28
7.7%
White
197
92.1%
128
84.8%
325
89%
More than one race
0
0%
0
0%
0
0%
Unknown or Not Reported
0
0%
0
0%
0
0%

Outcome Measures

1. Primary Outcome
TitleRate of Severe Visual Distortions
DescriptionThe rate of severe visual distortions under overall circumstances for the five visual distortion items of interest (lines that slant, tilt, split or separate; flat surfaces appearing curved; objects appearing further away or closer than they are; objects appearing to have a different size or shape; and physical discomfort related to vision). The six month data were used for this endpoint if available and if not an earlier visit was used. If a subject had a lens repositioning the questionnaire prior to the repositioning was used if available.
Time Frame6 months

Outcome Measure Data

Analysis Population Description
All subjects bilaterally implanted with a toric IOL (ZCT300 or ZCT400) and all subjects bilaterally implanted with a control IOL (ZCB00). All subjects who were monocularly implanted with a toric IOL (ZCT300/400) or control were excluded from the analysis.
Arm/Group TitleToric IOLNon-toric IOL
Arm/Group DescriptionExperimental (ZCT300, ZCT400)Control (ZCB00)
Measure Participants189144
With No severe visual distortion
189
88.3%
142
94%
With severe visual distortion
0
0%
2
1.3%

Adverse Events

Time FrameAll AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.
Adverse Event Reporting Description
Arm/Group TitleToric IOLNon-toric IOL
Arm/Group DescriptionExperimental (ZCT300, ZCT400)Control (ZCB00)
All Cause Mortality
Toric IOLNon-toric IOL
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total1/214 (0.5%) 2/151 (1.3%)
Serious Adverse Events
Toric IOLNon-toric IOL
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total32/214 (15%) 16/151 (10.6%)
Eye disorders
Epiretinal membrane with significant Vitreo-Retinal traction1/214 (0.5%) 10/151 (0%) 0
Cystoid Macular Edema6/214 (2.8%) 85/151 (3.3%) 5
Macular Hole1/214 (0.5%) 10/151 (0%) 0
Clinically Significant Macular Edema0/214 (0%) 01/151 (0.7%) 1
Elevated intraocular pressure requiring treatment2/214 (0.9%) 20/151 (0%) 0
Capsular Rupture1/214 (0.5%) 10/151 (0%) 0
Retinal Detachment1/214 (0.5%) 10/151 (0%) 0
Hyphema1/214 (0.5%) 10/151 (0%) 0
Macular Edema1/214 (0.5%) 10/151 (0%) 0
Capsular Tear1/214 (0.5%) 10/151 (0%) 0
Vitreous Strand1/214 (0.5%) 10/151 (0%) 0
Gastrointestinal disorders
Ulcerative Colitis1/214 (0.5%) 10/151 (0%) 0
General disorders
Hospitalization2/214 (0.9%) 28/151 (5.3%) 9
Death1/214 (0.5%) 12/151 (1.3%) 2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer1/214 (0.5%) 10/151 (0%) 0
Breast Cancer2/214 (0.9%) 20/151 (0%) 0
Surgical and medical procedures
Lens repositioning12/214 (5.6%) 120/151 (0%) 0
Residual Cortical material1/214 (0.5%) 11/151 (0.7%) 1
Vascular disorders
Crerebrovascular Accident1/214 (0.5%) 10/151 (0%) 0
Other (Not Including Serious) Adverse Events
Toric IOLNon-toric IOL
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/214 (0%) 1/151 (0.7%)
Eye disorders
Cystoid Macular Edema0/214 (0%) 01/151 (0.7%) 2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The sponsor must review results communication prior to public release and can embargo communications regarding trial results at any time.

Results Point of Contact

Name/TitleDevi Priya Janakiraman, OD, FAAO
OrganizationJohnson & Johnson Surgical Vision
Phone+1 714 247- 8628
Emaildjanaki1@its.jnj.com
Responsible Party:
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT02566083
Other Study ID Numbers:
  • TIOL-202-TPAS
First Posted:
Oct 1, 2015
Last Update Posted:
Jan 18, 2020
Last Verified:
Jan 1, 2020