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Clinical Investigation of the AcrySof® IQ PanOptix™ 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: NCT03090256
Recruitment Status : Completed
First Posted : March 24, 2017
Results First Posted : September 24, 2019
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
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Brief Summary:
The purpose of this study is to evaluate the effectiveness and safety of the AcrySof® IQ PanOptix™ Intraocular Lens (IOL) Model TFNT00 when implanted to replace the natural lens following cataract removal.

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

Detailed Description:
Eligible subjects will attend a total of 10 visits over a 7-month period. Subjects will complete a preoperative examination of both eyes (Visit 0), followed by implantation of the IOL at the operative visit for each eye (Visit 00/00A), and up to 7 postoperative visits (each eye examined at Day 1-2 (Visit 1/1A), Day 7-14 (Visit 2/2A), and Day 30-60 (Visit 3/3A), with a binocular visit at Day 120-180 (Visit 4A) after the second implantation. The second implantation will occur within 30 days of the first.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Investigation of the AcrySof® IQ PanOptix™ IOL Model TFNT00
Actual Study Start Date : April 11, 2017
Actual Primary Completion Date : February 13, 2018
Actual Study Completion Date : February 13, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

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


Outcome Measures
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Primary Outcome Measures :
  1. Monocular Photopic Best Corrected Distance Visual Acuity (5 m) [ Time Frame: Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation ]
    Visual acuity (VA) was tested monocularly (each eye separately) under well-lit conditions with the subject's best spectacle correction at a distance of 5 meters (m) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study.

  2. Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) [ Time Frame: Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation ]
    VA was tested monocularly under well-lit conditions using a chart. Distance-corrected VA at 60 cm is the VA at 60 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study.

  3. Monocular Photopic Distance Corrected Near Visual Acuity (40 cm) [ Time Frame: Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation ]
    VA was tested monocularly under well-lit conditions using a chart. Distance-corrected VA at 40 cm is the VA at 40 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to comprehend and sign a statement of informed consent;
  • Willing and able to complete all required postoperative visits;
  • Cataracts in both eyes with planned cataract removal by phacoemulsification;
  • Calculated lens power within the available range;
  • Potential postoperative best corrected distance visual acuity (BCDVA) of 0.5 decimal or better in both eyes;
  • Able to undergo second eye surgery within 30 days of the first eye surgery.

Exclusion Criteria:

  • Significant irregular corneal aberration as demonstrated by corneal topography;
  • Inflammation or edema (swelling) of the cornea affecting post-operative visual acuity;
  • Degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future acuity losses;
  • Previous refractive surgery;
  • Diabetic retinopathy
  • Other eye conditions as specified in the protocol
  • Pregnant.
Contacts and Locations
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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): NCT03090256


Locations
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Japan
Alcon Investigative Site
Fukuoka, Japan, 812-0011
Alcon Investigative Site
Tokyo, Japan, 101-0061
Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Group Manager, Clinical Development Alcon Japan, Ltd.
  Study Documents (Full-Text)

Documents provided by Alcon Research:
Study Protocol  [PDF] January 23, 2017
Statistical Analysis Plan  [PDF] December 3, 2017

More Information
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT03090256    
Other Study ID Numbers: ILH297-C003
First Posted: March 24, 2017    Key Record Dates
Results First Posted: September 24, 2019
Last Update Posted: September 24, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Alcon Research:
Trifocal IOL
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases