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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02649842
Recruitment Status : Completed
First Posted : January 8, 2016
Results First Posted : December 27, 2019
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions Cataract
Astigmatism
Intervention Device: TECNIS Toric Models ZCT450, ZCT525 or ZCT600
Enrollment 101
Recruitment Details  
Pre-assignment Details Per 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 Title Extended Cylinder IOL
Hide Arm/Group Description All subjects implanted with an extended cylinder IOL (ZCT450, ZCT525 or ZCT600) in at least one eye.
Period Title: Overall Study
Started 101
Completed 101
Not Completed 0
Arm/Group Title Extended Cylinder IOL
Hide Arm/Group Description All subjects implanted with an extended cylinder IOL (ZCT450, ZCT525 or ZCT600) in at least one eye.
Overall Number of Baseline Participants 101
Overall Number of Units Analyzed
Type of Units Analyzed: Primary Eyes
 101
Hide Baseline Analysis Population Description
All subjects with an extended (high) cylinder IOL (ZCT450, ZCT525 or ZCT600) in at least one eye.Per the statistical plan, data for the ZCT450,ZCT525 and ZCT600 toric IOLs were to be pooled together and reported as one group.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 101 participants
65.5  (12.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants
Female
50
  49.5%
Male
51
  50.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants
American Indian or Alaska Native
0
   0.0%
Asian
3
   3.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   1.0%
White
94
  93.1%
More than one race
0
   0.0%
Unknown or Not Reported
3
   3.0%
1.Primary Outcome
Title Rate of Severe Visual Distortions
Hide Description Rate of severe visual distortions based on data from a self administered subject questionnaire
Time Frame 6 months
Hide Outcome Measure Data
Hide 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 Title Extended Cylinder IOL
Hide Arm/Group Description:
All subjects implanted with an extended cylinder IOL (ZCT450, ZCT525 or ZCT600) in at least one eye.
Overall Number of Participants Analyzed 100
Measure Type: Count of Participants
Unit of Measure: Participants
3
   3.0%
2.Other Pre-specified Outcome
Title Rate of IOL Repositioning Due to IOL Misalignment
Hide Description Rate of IOL repositioning due to IOL misalignment in primary and fellow eyes with a high cylinder toric IOL
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects implanted with a ZCT450/525/600 in at least one eye
Arm/Group Title Extended Cylinder IOL
Hide Arm/Group Description:
All subjects implanted with an extended cylinder IOL (ZCT450, ZCT525 or ZCT600)
Overall Number of Participants Analyzed 101
Measure Type: Count of Participants
Unit of Measure: Participants
11
  10.9%
3.Other Pre-specified Outcome
Title Percent Change in Cylinder
Hide Description Percent change in cylinder= ((postop refractive cylinder-preop keratometric cylinder) / (Target refractive cylinder-preop keratometric cylinder))*100
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects implanted with a ZCT450/525/600 in at least one eye
Arm/Group Title Extended Cylinder IOL
Hide Arm/Group Description:
All subjects implanted with a ZCT450/525/600 in at least one eye
Overall Number of Participants Analyzed 101
Mean (Standard Deviation)
Unit of Measure: Percent change
88.36  (21.09)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Extended Cylinder IOL
Hide Arm/Group Description All 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 (%)
Total   0/101 (0.00%)    
Hide Serious Adverse Events
Extended Cylinder IOL
Affected / at Risk (%) # Events
Total   19/101 (18.81%)    
Eye disorders   
Hyphema † [1]  1/101 (0.99%)  1
Cystoid Macular Edema † [2]  1/101 (0.99%)  1
General disorders   
Hospitalization due to unsteady gait/dizziness †  1/101 (0.99%)  1
Injury, poisoning and procedural complications   
Hospitalization due to fall and broken hip †  1/101 (0.99%)  1
Hospitalization due to motorcycle accident †  1/101 (0.99%)  1
Skin and subcutaneous tissue disorders   
Squamous Cell Carcinoma - Left second finger †  1/101 (0.99%)  1
Surgical and medical procedures   
Lens misalignment requiring IOL repositioning † [3]  11/101 (10.89%)  12
Hospitalization due to appendectomy due to appendicitis †  1/101 (0.99%)  1
Lens exchange due to residual astigmatism and myopia † [2]  1/101 (0.99%)  1
†
Indicates events were collected by systematic assessment
[1]
1 participant implanted with ZCT400
[2]
1 participant implanted with ZCT525
[3]
6 participants (6 events) with ZCT600, 4 participants (5 events) with ZCT450 and 1 participant (1 event) with ZCT400
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Extended Cylinder IOL
Affected / at Risk (%) # Events
Total   1/101 (0.99%)    
Eye disorders   
Iridocyclitis † [1]  1/101 (0.99%)  1
†
Indicates events were collected by systematic assessment
[1]
1 participant implanted with ZCT450
[Not Specified]
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 sponsor must review results communication prior to public release and can embargo communications regarding trial results at any time.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Devi Priya Janakiraman, OD, FAAO
Organization: Johnson & Johnson Surgical Vision
Phone: 1+ 714-247-8429
EMail: djanaki1@its.jnj.com
Layout table for additonal information
Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT02649842    
Other Study ID Numbers: TIOL-204-EPAS
First Submitted: January 6, 2016
First Posted: January 8, 2016
Results First Submitted: August 20, 2019
Results First Posted: December 27, 2019
Last Update Posted: January 22, 2020