Back to resultsClinical Investigation of an AcrySof IQ PanOptix Toric Intraocular Lens
Primary Purpose
Aphakia, Corneal Astigmatism
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
ACRYSOF IQ PanOptix Toric Trifocal IOL
Cataract surgery
Sponsored by
About this trial
This is an interventional treatment trial for Aphakia focused on measuring Cataract, Intraocular lens, Astigmatism, Toric
Eligibility Criteria
Key Inclusion Criteria:
- Eligible to be implanted with AcrySof IQ PanOptix Toric Intraocular Lens Model TFNT20 in at least one eye.
- Potential postoperative Best Corrected Distance Visual Acuity (BCDVA) of 0.5 decimal or better.
- Other protocol-specified inclusion criteria may apply.
Key Exclusion Criteria:
- Irregular corneal astigmatism.
- History of anterior segment, posterior segment, or optic nerve pathology.
- History of previous intraocular or corneal (refractive or trauma related) surgery.
- Any other planned ocular surgical procedures including but not limited to limbal relaxing incision (LRI)/Astigmatic Keratotomy and laser assisted in situ keratomileusis (LASIK).
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
- Alcon Investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PanOptix Toric Trifocal IOL
Arm Description
ACRYSOF IQ PanOptix Toric Trifocal IOL Model TFNT20 implanted in the capsular bag in the posterior chamber following cataract surgery. At least one eye will be implanted.
Outcomes
Primary Outcome Measures
Percentage of Eyes With ≤ 0.25 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60)
A manifest refraction (manual vision test) was conducted using charts. Refractive cylinder is the amount of power in diopters that is needed to correct any remaining astigmatism.
Secondary Outcome Measures
Percentage of Eyes With ≤ 0.5 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60)
A manifest refraction (manual vision test) was conducted using charts. Refractive cylinder is the amount of power in diopters that is needed to correct any remaining astigmatism. No confirmatory statistical hypothesis testing was pre-specified in the protocol.
Average Absolute Manifest Refractive Cylinder at Visit 3/3A (Day 30-60)
A manifest refraction (manual vision test) was conducted using charts. Refractive cylinder is the amount of power in diopters that is needed to correct any remaining astigmatism. No confirmatory statistical hypothesis testing was pre-specified in the protocol.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04542525
Brief Title
Clinical Investigation of an AcrySof IQ PanOptix Toric Intraocular Lens
Official Title
Clinical Investigation of AcrySof IQ PanOptix Toric Intraocular Lens Model TFNT20
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
August 10, 2021 (Actual)
Study Completion Date
August 10, 2021 (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
Device Product Not Approved or Cleared by U.S. FDA
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 TFNT20 low cylinder power intraocular lens when implanted in the eye to replace the natural lens following cataract removal.
Detailed Description
Subjects will attend a total of 5 to 9 visits, depending on whether one eye or both eyes are implanted. The second eye surgery, if applicable, will occur 1 to 30 days after the first eye surgery. Total individual duration of participation will be up to 4 months, including an up to 2-month preoperative period.
This study will be conducted in Japan.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphakia, Corneal Astigmatism
Keywords
Cataract, Intraocular lens, Astigmatism, Toric
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PanOptix Toric Trifocal IOL
Arm Type
Experimental
Arm Description
ACRYSOF IQ PanOptix Toric Trifocal IOL Model TFNT20 implanted in the capsular bag in the posterior chamber following cataract surgery. At least one eye will be implanted.
Intervention Type
Device
Intervention Name(s)
ACRYSOF IQ PanOptix Toric Trifocal IOL
Other Intervention Name(s)
PanOptix Toric Trifocal IOL, Model TFNT20
Intervention Description
Single-piece, ultraviolet and blue-light filtering, foldable, multifocal toric IOL intended to provide vision to aphakic subjects at near, intermediate, and distance and to correct pre-existing corneal astigmatism
Intervention Type
Procedure
Intervention Name(s)
Cataract surgery
Intervention Description
Cataract extraction by phacoemulsification, followed by implantation of the IOL per investigator's standard of care and instructions for use
Primary Outcome Measure Information:
Title
Percentage of Eyes With ≤ 0.25 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60)
Description
A manifest refraction (manual vision test) was conducted using charts. Refractive cylinder is the amount of power in diopters that is needed to correct any remaining astigmatism.
Time Frame
Day 30-60 postoperative
Secondary Outcome Measure Information:
Title
Percentage of Eyes With ≤ 0.5 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60)
Description
A manifest refraction (manual vision test) was conducted using charts. Refractive cylinder is the amount of power in diopters that is needed to correct any remaining astigmatism. No confirmatory statistical hypothesis testing was pre-specified in the protocol.
Time Frame
Day 30-60 postoperative
Title
Average Absolute Manifest Refractive Cylinder at Visit 3/3A (Day 30-60)
Description
A manifest refraction (manual vision test) was conducted using charts. Refractive cylinder is the amount of power in diopters that is needed to correct any remaining astigmatism. No confirmatory statistical hypothesis testing was pre-specified in the protocol.
Time Frame
Day 30-60 postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Eligible to be implanted with AcrySof IQ PanOptix Toric Intraocular Lens Model TFNT20 in at least one eye.
Potential postoperative Best Corrected Distance Visual Acuity (BCDVA) of 0.5 decimal or better.
Other protocol-specified inclusion criteria may apply.
Key Exclusion Criteria:
Irregular corneal astigmatism.
History of anterior segment, posterior segment, or optic nerve pathology.
History of previous intraocular or corneal (refractive or trauma related) surgery.
Any other planned ocular surgical procedures including but not limited to limbal relaxing incision (LRI)/Astigmatic Keratotomy and laser assisted in situ keratomileusis (LASIK).
Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sr. Clinical Trial Lead, CDMA Surgical
Organizational Affiliation
Alcon Japan Limited
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Investigative Site
City
Chiyoda-Ku
State/Province
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 an AcrySof IQ PanOptix Toric Intraocular Lens
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