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Clinical Investigation of the AcrySof® IQ PanOptix™ IOL

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
AcrySof® IQ PanOptix™ IOL
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Trifocal IOL

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alcon Investigative Site
  • Alcon Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PanOptix IOL

Arm Description

AcrySof® IQ PanOptix™ IOL, bilateral implantation

Outcomes

Primary Outcome Measures

Monocular Photopic Best Corrected Distance Visual Acuity (5 m)
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.
Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm)
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.
Monocular Photopic Distance Corrected Near Visual Acuity (40 cm)
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.

Secondary Outcome Measures

Full Information

First Posted
March 20, 2017
Last Updated
August 30, 2019
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT03090256
Brief Title
Clinical Investigation of the AcrySof® IQ PanOptix™ IOL
Official Title
Clinical Investigation of the AcrySof® IQ PanOptix™ IOL Model TFNT00
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 11, 2017 (Actual)
Primary Completion Date
February 13, 2018 (Actual)
Study Completion Date
February 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Trifocal IOL

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PanOptix IOL
Arm Type
Experimental
Arm Description
AcrySof® IQ PanOptix™ IOL, bilateral implantation
Intervention Type
Device
Intervention Name(s)
AcrySof® IQ PanOptix™ IOL
Other Intervention Name(s)
Model TFNT00
Intervention Description
Multifocal intraocular lens (IOL) (near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient
Primary Outcome Measure Information:
Title
Monocular Photopic Best Corrected Distance Visual Acuity (5 m)
Description
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.
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
Title
Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm)
Description
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.
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
Title
Monocular Photopic Distance Corrected Near Visual Acuity (40 cm)
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Group Manager, Clinical Development
Organizational Affiliation
Alcon Japan, Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Investigative Site
City
Fukuoka
ZIP/Postal Code
812-0011
Country
Japan
Facility Name
Alcon Investigative Site
City
Tokyo
ZIP/Postal Code
101-0061
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Investigation of the AcrySof® IQ PanOptix™ IOL

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