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Retrospective / Prospective Clinical Study of AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric Intraocular Lenses

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ClinicalTrials.gov Identifier: NCT02176343
Recruitment Status : Completed
First Posted : June 27, 2014
Results First Posted : June 29, 2017
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Tracking Information
First Submitted Date  ICMJE June 25, 2014
First Posted Date  ICMJE June 27, 2014
Results First Submitted Date  ICMJE March 29, 2017
Results First Posted Date  ICMJE June 29, 2017
Last Update Posted Date July 2, 2018
Actual Study Start Date  ICMJE July 21, 2014
Actual Primary Completion Date August 22, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2017)
  • Mean Percent Reduction in Cylinder [ Time Frame: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation) ]
    Manifest refraction cylinder was measured monocularly (each eye separately) with best correction (phoropter or trial lenses) under photopic (well-lit) lighting conditions using a 100% contrast ETDRS chart at 4 meters (m) from the subject. Percent reduction in cylinder was calculated as the difference between the postoperative magnitude of manifest refractive cylinder and the preoperative magnitude of keratometric cylinder divided by the intended reduction in cylinder [defined as the difference between the intended (from toric calculator) magnitude of the postoperative manifest refractive cylinder and the preoperative keratometric cylinder], multiplied by 100%. One eye (primary eye) contributed to the analysis.
  • Percentage of Subjects With Manifest Refraction Cylinder ≤ 0.50 D [ Time Frame: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation) ]
    Manifest refraction cylinder was measured monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m from the subject. One eye (primary eye) contributed to the analysis.
  • Percentage of Subjects (With Preoperative Astigmatism > 1.00 D) With Manifest Refraction Cylinder ≤ 1.00 D [ Time Frame: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation) ]
    Manifest refraction cylinder was measured monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m from the subject. One eye (primary eye) contributed to the analysis.
  • Mean Uncorrected Distance Visual Acuity [ Time Frame: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation) ]
    Visual Acuity (VA) was tested monocularly without visual correction under photopic (well-lit) conditions using a 100% contrast ETDRS chart positioned 4 m from the subject. A +0.25 D spherical power additional lens was used to correct for optical infinity. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.
  • Mean Uncorrected Near Visual Acuity [ Time Frame: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation) ]
    VA was tested monocularly without visual correction under photopic lighting conditions using a 100% contrast near ETDRS chart set at 40 cm on the nearpoint rod of the phoropter. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.
  • Mean Uncorrected Intermediate Visual Acuity [ Time Frame: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation) ]
    VA was tested monocularly without visual correction under photopic lighting conditions using a 100% contrast near ETDRS chart set at 53 cm on the nearpoint rod of the phoropter. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.
  • Mean Best Corrected Distance Visual Acuity (BCDVA) [ Time Frame: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation) ]
    VA was tested monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m away from the subject. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.
  • Mean IOL Rotation [ Time Frame: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation) ]
    Lens axis orientation (position of the lens within the capsular bag) as indicated by indentations on the IOL was assessed during slit lamp examination. IOL rotation (the difference between the achieved lens axis orientation at visit and achieved axis placement at surgery) was measured in degrees. One eye (primary eye) contributed to the analysis.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT02176343 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 Retrospective / Prospective Clinical Study of AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric Intraocular Lenses
Official Title  ICMJE Retrospective / Prospective Clinical Study of AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric Intraocular Lenses
Brief Summary The purpose of this study is to characterize the safety and effectiveness of the ACRYSOF IQ ReSTOR +2.5 diopter (D) Multifocal Toric Intraocular Lens (IOL) in subjects at least 3 months and no more than 14 months after IOL implantation.
Detailed Description This is a retrospective and prospective clinical study comprised of a retrospective chart review for preoperative, surgical and early postoperative data, and a prospective postoperative visit conducted at least 3 months but not more than 14 months after IOL implantation.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Cataract
  • Presbyopia
  • Corneal Astigmatism
Intervention  ICMJE Device: AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient
Other Names:
  • Model SV25T2
  • Model SV25T3
  • Model SV25T4
  • Model SV25T5
Study Arms  ICMJE Experimental: ReSTOR Toric +2.5
AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL previously implanted during cataract surgery
Intervention: Device: AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
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: May 30, 2017)
37
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 22, 2014
Actual Primary Completion Date August 22, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must sign an informed consent form and be willing to come in for a visit at least 3 months and not more than 14 months after IOL implantation with the AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL (Models SV25T2, SV25T3, SV25T4 and SV25T5);
  • Must be implanted with the correct lens based on preoperative corneal astigmatism as specified in the protocol;
  • Must complete a visit within 10 days after IOL implantation;
  • Successful capsular bag implantation with no surgical complications;
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • IOL implanted prior to the AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL;
  • Ocular or intraocular infection or inflammation at the time of the preoperative visit;
  • Any ocular surgery or intraocular laser procedure at or prior to the surgical visit;
  • Any conditions affecting the cornea (eg. corneal dystrophy, severe dry eye) at the preoperative visit;
  • Retinal conditions (e.g. degenerative retinal conditions, history of retinal detachment, diabetic retinopathy) at the preoperative visit;
  • Known history of Type 1 or 2 diabetes for more than 5 years;
  • Any ocular or systemic co-morbidity at the preoperative visit;
  • Pregnant at the preoperative visit or at the time of Postoperative Visit 2;
  • Preoperative corneal astigmatism ≤ 0.50 D;
  • Participation in another clinical study at the preoperative visit or at the time of the final study visit;
  • Other protocol-specified exclusion criteria may apply.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02176343
Other Study ID Numbers  ICMJE C-14-005
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: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alcon Research
Study Sponsor  ICMJE Alcon Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Manager, GCRA, Surgical Alcon Research
PRS Account Alcon Research
Verification Date May 2017

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