Post-Approval Study of the TECNIS® Toric Extended Cylinder Range Intraocular Lens (IOL)

Sponsor
Abbott Medical Optics (Industry)
Overall Status
Completed
CT.gov ID
NCT02649842
Collaborator
(none)
101
Enrollment
20
Locations
1
Arm
34.3
Actual Duration (Months)
5.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a prospective, multicenter, bilateral, non-randomized, open-label, clinical study conducted at up to 20 sites in the USA. Subjects were to be bilaterally implanted with one eye having an extended cylinder (high cylinder) toric IOL (model ZCT450, ZCT525 or ZCT600) and the fellow eye having a high cylinder toric IOL (model ZCT450, ZCT525 or ZCT600) or a lower cylinder toric IOL (ZCT300 or ZCT400). This study evaluates the outcomes for subjects implanted with at least one higher cylinder toric IOL.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: TECNIS Toric Models ZCT450, ZCT525 or ZCT600
N/A

Detailed Description

The purpose of this study is to evaluate the performance of the higher cylinder (ZCT450,ZCT525 and ZCT600) toric IOLs. Some subjects had the higher cylinder toric IOLs in both eyes with other subjects having a higher cylinder toric IOL in one eye and the lower cylinder toric IOL in the other eye.

Per the statistical plan, data for the ZCT450/525/600 toric IOLs were to be pooled together and reported as one group.

The primary endpoint is the rate of severe visual distortions reported by subject at 6 months via questionnaire. The analysis population for this endpoint will be bilaterally implanted subjects with a high cylinder IOL (ZCT450/525/600) in the primary eye and a high cylinder IOL (ZCT450/525/600) or a low cylinder IOL (ZCT300/400) in the fellow eye.

There were no formal secondary endpoints. Data from a few other endpoints (rate of IOL repositioning due to IOL misalignment and percent change in cylinder) have been reported. For these endpoints the analysis population contains all subjects implanted with a ZCT450/525/600 in at least one eye.

Adverse events were reported by subject for all subjects with a high cylinder IOL (ZCT450/525/600) in at least one eye.

Study Design

Study Type:
Interventional
Actual Enrollment :
101 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Post-Approval Study of the TECNIS® Toric IOL Extended Cylinder Range (ECR), Models ZCT450, ZCT525 and ZCT600
Actual Study Start Date :
Mar 21, 2016
Actual Primary Completion Date :
Aug 27, 2018
Actual Study Completion Date :
Jan 28, 2019

Arms and Interventions

ArmIntervention/Treatment
Experimental: Extended Cylinder IOL

Approved toric intraocular lenses, Model ZCT450, ZCT525 or ZCT600

Device: TECNIS Toric Models ZCT450, ZCT525 or ZCT600
Approved toric intraocular lens

Outcome Measures

Primary Outcome Measures

  1. Rate of Severe Visual Distortions [6 months]

    Rate of severe visual distortions based on data from a self administered subject questionnaire

Other Outcome Measures

  1. Rate of IOL Repositioning Due to IOL Misalignment [6 months]

    Rate of IOL repositioning due to IOL misalignment in primary and fellow eyes with a high cylinder toric IOL

  2. Percent Change in Cylinder [6 months]

    Percent change in cylinder= ((postop refractive cylinder-preop keratometric cylinder) / (Target refractive cylinder-preop keratometric cylinder))*100

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Minimum 22 years of age

  • Bilateral cataracts

  • Preoperative keratometric cylinder of at least 2.00 D in both eyes with at least one eye having approximately 3.00 D to 4.75 D of corneal astigmatism.

  • 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 or 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

  • 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 or is lactating

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Eye Center SouthDothanAlabamaUnited States36301
2Arizona Eye CenterChandlerArizonaUnited States85225
3Fishkind, Bakewell & Maltzman Eye Care & Surgery CenterTucsonArizonaUnited States85704
4Scripps Clinical Medical GroupLa JollaCaliforniaUnited States92037
5Southern California Eye Physicians & AssociatesLong BeachCaliforniaUnited States90805
6Katzen Eye Care & Laser CenterBoynton BeachFloridaUnited States33426
7Levenson Eye Associates, Inc.JacksonvilleFloridaUnited States32204
8Virdi Eye Clinic & Laser Vision CenterRock IslandIllinoisUnited States61201
9Senior Health ServicesLouisvilleKentuckyUnited States40220
10Chesapeake Eye Care and Laser CenterAnnapolisMarylandUnited States21401
11Eye Doctors of WashingtonChevy ChaseMarylandUnited States20815
12Mercy ResearchSpringfieldMissouriUnited States65804
13Kindermann Eye AssociatesCherry HillNew JerseyUnited States08002
14Eye Associates of New MexicoAlbuquerqueNew MexicoUnited States87109
15Pamel Vision & Laser GroupNew YorkNew YorkUnited States10065
16Carolina Cataract & Laser CenterLadsonSouth CarolinaUnited States29456
17Carolina Eyecare Physicians, LLCPleasantSouth CarolinaUnited States29464
18Vance Thompson VisionSioux FallsSouth DakotaUnited States57108
19Texas Eye and Laser CenterHurstTexasUnited States76054
20Clarus Eye CentreLaceyWashingtonUnited States98503

Sponsors and Collaborators

  • Abbott Medical Optics

Investigators

  • Study Director: Devi Priya Janakiraman, OD,FAAO, Abbott Medical Optics

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT02649842
Other Study ID Numbers:
  • TIOL-204-EPAS
First Posted:
Jan 8, 2016
Last Update Posted:
Jan 22, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment DetailPer SAP there is only one arm. It includes all subjects with ZCT450/525/600 toric IOL in the primary eye.Fellow eye can have the same IOL or a ZCT300/400.
Arm/Group TitleExtended Cylinder IOL
Arm/Group DescriptionAll subjects implanted with an extended cylinder IOL (ZCT450, ZCT525 or ZCT600) in at least one eye.
Period Title: Overall Study
STARTED101
COMPLETED101
NOT COMPLETED0

Baseline Characteristics

Arm/Group TitleExtended Cylinder IOL
Arm/Group DescriptionAll subjects implanted with an extended cylinder IOL (ZCT450, ZCT525 or ZCT600) in at least one eye.
Overall Participants101
Overall Primary Eyes101
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
65.5
(12.0)
Sex: Female, Male (Count of Participants)
Female
50
49.5%
Male
51
50.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
Asian
3
3%
Native Hawaiian or Other Pacific Islander
0
0%
Black or African American
1
1%
White
94
93.1%
More than one race
0
0%
Unknown or Not Reported
3
3%

Outcome Measures

1. Primary Outcome
TitleRate of Severe Visual Distortions
DescriptionRate of severe visual distortions based on data from a self administered subject questionnaire
Time Frame6 months

Outcome Measure Data

Analysis Population Description
All subjects implanted with a high cylinder toric IOL (model ZCT450, ZCT525 or ZCT600) in at least one eye and a high cylinder or low cylinder toric IOL in the fellow eye.
Arm/Group TitleExtended Cylinder IOL
Arm/Group DescriptionAll subjects implanted with an extended cylinder IOL (ZCT450, ZCT525 or ZCT600) in at least one eye.
Measure Participants100
Count of Participants [Participants]
3
3%
2. Other Pre-specified Outcome
TitleRate of IOL Repositioning Due to IOL Misalignment
DescriptionRate of IOL repositioning due to IOL misalignment in primary and fellow eyes with a high cylinder toric IOL
Time Frame6 months

Outcome Measure Data

Analysis Population Description
All subjects implanted with a ZCT450/525/600 in at least one eye
Arm/Group TitleExtended Cylinder IOL
Arm/Group DescriptionAll subjects implanted with an extended cylinder IOL (ZCT450, ZCT525 or ZCT600)
Measure Participants101
Count of Participants [Participants]
11
10.9%
3. Other Pre-specified Outcome
TitlePercent Change in Cylinder
DescriptionPercent change in cylinder= ((postop refractive cylinder-preop keratometric cylinder) / (Target refractive cylinder-preop keratometric cylinder))*100
Time Frame6 months

Outcome Measure Data

Analysis Population Description
All subjects implanted with a ZCT450/525/600 in at least one eye
Arm/Group TitleExtended Cylinder IOL
Arm/Group DescriptionAll subjects implanted with a ZCT450/525/600 in at least one eye
Measure Participants101
Mean (Standard Deviation) [Percent change]
88.36
(21.09)

Adverse Events

Time Frame6 months
Adverse Event Reporting Description
Arm/Group TitleExtended Cylinder IOL
Arm/Group DescriptionAll subjects implanted with an extended cylinder IOL (ZCT450, ZCT525 or ZCT600) in at least one eye. Subject is considered to have adverse events whether the adverse event was in the higher cylinder or lower cylinder group.
All Cause Mortality
Extended Cylinder IOL
Affected / at Risk (%)# Events
Total0/101 (0%)
Serious Adverse Events
Extended Cylinder IOL
Affected / at Risk (%)# Events
Total19/101 (18.8%)
Eye disorders
Hyphema1/101 (1%) 1
Cystoid Macular Edema1/101 (1%) 1
General disorders
Hospitalization due to unsteady gait/dizziness1/101 (1%) 1
Injury, poisoning and procedural complications
Hospitalization due to fall and broken hip1/101 (1%) 1
Hospitalization due to motorcycle accident1/101 (1%) 1
Skin and subcutaneous tissue disorders
Squamous Cell Carcinoma - Left second finger1/101 (1%) 1
Surgical and medical procedures
Lens misalignment requiring IOL repositioning11/101 (10.9%) 12
Hospitalization due to appendectomy due to appendicitis1/101 (1%) 1
Lens exchange due to residual astigmatism and myopia1/101 (1%) 1
Other (Not Including Serious) Adverse Events
Extended Cylinder IOL
Affected / at Risk (%)# Events
Total1/101 (1%)
Eye disorders
Iridocyclitis1/101 (1%) 1

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
Phone1+ 714-247-8429
Emaildjanaki1@its.jnj.com
Responsible Party:
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT02649842
Other Study ID Numbers:
  • TIOL-204-EPAS
First Posted:
Jan 8, 2016
Last Update Posted:
Jan 22, 2020
Last Verified:
Jan 1, 2020