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Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting Intraocular Lens (IOL) Model TFNT00

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: NCT02529488
Recruitment Status : Completed
First Posted : August 20, 2015
Results First Posted : April 6, 2018
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study is to investigate visual outcomes and assess safety at 12 months (330-420 days) post bilateral implantation of the AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL.

Condition or disease Intervention/treatment Phase
Cataract Device: AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL Not Applicable

Detailed Description:
This study will be conducted in regions where the test article is approved at the time of study start.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 167 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL Model TFNT00
Actual Study Start Date : September 7, 2015
Actual Primary Completion Date : November 30, 2016
Actual Study Completion Date : June 26, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: TFNT00
AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation
Device: AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL
Multifocal IOL(near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient
Other Name: Model TFNT00




Primary Outcome Measures :
  1. Mean Binocular Defocus Visual Acuity (VA) [ Time Frame: Day 20-40 and Day 120-180 from second eye implantation ]
    Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly (both eyes together) with the subject's best spectacle correction at a distance of 4 meters. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. A lower numeric value represents better visual acuity. The defocus VA summaries are based on the number of subjects evaluable for Best-Case Analysis Set and have data available at the corresponding visit. No formal statistical hypothesis testing was planned.



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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of bilateral cataracts with planned cataract removal by phacoemulsification with a clear cornea incision;
  • Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures;
  • Clear intraocular media other than cataract in both eyes;
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Clinically significant corneal abnormalities including corneal dystrophy, inflammation or edema;
  • Ocular trauma, corneal transplant, retinal conditions, degenerative eye disorders, or color vision deficiencies;
  • Glaucoma (uncontrolled or controlled with medication) or ocular hypertension;
  • Pregnant or lactating;
  • Expected to require ocular surgical or retinal laser treatment;
  • Other protocol-specified exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02529488


Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Sr Clinical Manager, Cataract Alcon Research

Additional Information:
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02529488     History of Changes
Other Study ID Numbers: ILH297-P002
First Posted: August 20, 2015    Key Record Dates
Results First Posted: April 6, 2018
Last Update Posted: July 2, 2018
Last Verified: March 2018

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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
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Cataract
Presbyopia
Lens Diseases
Eye Diseases
Refractive Errors