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AcrySof Toric IQ Post-Market Clinical Study

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: NCT03350503
Recruitment Status : Active, not recruiting
First Posted : November 22, 2017
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Tracking Information
First Submitted Date  ICMJE November 16, 2017
First Posted Date  ICMJE November 22, 2017
Last Update Posted Date January 8, 2019
Actual Study Start Date  ICMJE January 30, 2018
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2017)
  • Percentage of patients with absolute value of IOL rotation of less than 10 degrees at Visit 4 from Visit 00 [ Time Frame: Visit 00 (Day 1 operative), Visit 4 (Day 120-180 postoperative) ]
    IOL rotation is defined as the IOL axis difference between study visits. A photograph of the eye will be taken, and IOL rotation will be calculated as the angle between the toric mark on the IOL at Visit 4 and the reference point from Visit 00 (minimum 0 degrees, maximum 180 degrees). A lower value indicates greater IOL stability.
  • Percentage of patients with absolute value of IOL rotation of less than 20 degrees at Visit 4 from Visit 00 [ Time Frame: Visit 00 (Day 1 operative), Visit 4 (Day 120-180 postoperative) ]
  • Percentage of patients with absolute value of IOL rotation of less than 30 degrees at Visit 4 from Visit 00 [ Time Frame: Visit 00 (Day 1 operative), Visit 4 (Day 120-180 postoperative) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03350503 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AcrySof Toric IQ Post-Market Clinical Study
Official Title  ICMJE AcrySof Toric IQ A-Code Post-Market Clinical Study
Brief Summary The purpose of this study is to clinically confirm the rotational stability of a modified AcrySof IQ toric intraocular lens (IOL) in a Japanese population.
Detailed Description Patients will be examined pre-operatively to up to 3 years post-operatively. One eligible eye will be selected as a target eye for efficacy analysis. If both eyes are eligible, the eye in which the IOL is implanted first will be selected as the target eye.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cataract
  • Astigmatism
Intervention  ICMJE
  • Device: AcrySof IQ Toric A-code IOL
    Intended to provide visual acuity, including astigmatism correction, over the lifetime of the cataract patient
    Other Name: Models SN6AT3, SN6AT4, SN6AT5
  • Procedure: Cataract surgery
    Removal of cataractous lens and implantation of IOL
Study Arms  ICMJE Experimental: Acrysof IQ Toric A-code IOL
IOL implanted during cataract surgery
Interventions:
  • Device: AcrySof IQ Toric A-code IOL
  • Procedure: Cataract surgery
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 7, 2019)
125
Original Estimated Enrollment  ICMJE
 (submitted: November 17, 2017)
120
Estimated Study Completion Date  ICMJE February 2022
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of cataracts with planned cataract removal by phacoemulsification
  • Calculated lens power within the available range
  • Able to sign informed consent and complete all study visits
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Eye conditions as specified in the protocol
  • Uncontrolled glaucoma
  • Pregnancy, current or planned
  • Other protocol-defined exclusion criteria may apply.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03350503
Other Study ID Numbers  ICMJE ILV814-P001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Alcon Research
Study Sponsor  ICMJE Alcon Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Alcon Research
Verification Date January 2019

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