We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE January 6, 2016
First Posted Date  ICMJE January 8, 2016
Results First Submitted Date  ICMJE August 20, 2019
Results First Posted Date  ICMJE December 27, 2019
Last Update Posted Date January 22, 2020
Actual Study Start Date  ICMJE March 21, 2016
Actual Primary Completion Date August 27, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2019)		 Rate of Severe Visual Distortions [ Time Frame: 6 months ]
Rate of severe visual distortions based on data from a self administered subject questionnaire
Original Primary Outcome Measures  ICMJE
 (submitted: January 6, 2016)		 Rate of severe visual distortions [ Time Frame: 6 months ]
Rate of visual distortions based on data collected from a self-administered subject questionnaire
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2016)
  • Rate of IOL repositioning procedures due to IOL misalignment [ Time Frame: 6 months ]
  • Rate of other adverse events [ Time Frame: 6 months ]
  • Rate of reduction in cylinder [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures
 (submitted: December 12, 2019)
  • Rate of IOL Repositioning Due to IOL Misalignment [ Time Frame: 6 months ]
    Rate of IOL repositioning due to IOL misalignment in primary and fellow eyes with a high cylinder toric IOL
  • Percent Change in Cylinder [ Time Frame: 6 months ]
    Percent change in cylinder= ((postop refractive cylinder-preop keratometric cylinder) / (Target refractive cylinder-preop keratometric cylinder))*100
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Post-Approval Study of the TECNIS® Toric Extended Cylinder Range Intraocular Lens (IOL)
Official Title  ICMJE Post-Approval Study of the TECNIS® Toric IOL Extended Cylinder Range (ECR), Models ZCT450, ZCT525 and ZCT600
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Cataract
  • Astigmatism
Intervention  ICMJE Device: TECNIS Toric Models ZCT450, ZCT525 or ZCT600
Approved toric intraocular lens
Study Arms  ICMJE Experimental: Extended Cylinder IOL
Approved toric intraocular lenses, Model ZCT450, ZCT525 or ZCT600
Intervention: Device: TECNIS Toric Models ZCT450, ZCT525 or ZCT600
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 12, 2019)		 101
Original Estimated Enrollment  ICMJE
 (submitted: January 6, 2016)		 90
Actual Study Completion Date  ICMJE January 28, 2019
Actual Primary Completion Date August 27, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02649842
Other Study ID Numbers  ICMJE TIOL-204-EPAS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Abbott Medical Optics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Abbott Medical Optics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Devi Priya Janakiraman, OD,FAAO Abbott Medical Optics
PRS Account Abbott Medical Optics
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP