Clareon Toric vs Eyhance Toric
Primary Purpose
Cataract, Aphakia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clareon IOL
Clareon Toric IOL
Eyhance IOL
Eyhance Toric IOL
Phacoemulsification surgery
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring Cataracts, Phacoemulsification, IOL
Eligibility Criteria
Key Inclusion Criteria:
- Planned bilateral cataract removal by routine small incision phacoemulsification surgery;
- Planned implantation of either test or comparator IOL (per randomization) in at least one eye with approximately 1.00 - 3.00 diopter (D) of preoperative corneal astigmatism;
- Predicted postoperative astigmatism of ≤ 0.5 D in both operative eyes based on a Toric calculator;
- Other protocol-specified inclusion criteria may apply.
Key Exclusion Criteria:
- Any disease or pathology, other than cataract, that (in the investigator's opinion) may reduce the potential BCDVA to a level worse than 0.2 logMAR;
- Clinically significant (in the investigator's opinion) corneal pathology, dry-eye or ocular surface disease that would adversely affect a) the biometry measures and/or toric calculations and b) the visual outcome;
- History of previous intraocular or corneal surgery (including laser-assisted in situ keratomileusis (LASIK));
- Any other planned ocular surgical procedures including but not limited to limbal relaxing incision (LRI), astigmatic keratotomy, LASIK, and retinal laser treatment within the study time frame;
- Other protocol-specified exclusion criteria may apply.
Sites / Locations
- Chu Vision Institute
- Seeta Eye Centers
- Cleveland Eye Clinic
- Carolina Eyecare Physicians, LLC
- Vision for Life
- Texan Eye
- Houston Eye Associates
- Berkeley Eye Center
- Texas Eye Research Center
- The Eye Institute of Utah
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Clareon/Clareon Toric
Eyhance/Eyhance Toric
Arm Description
Phacoemulsification surgery, followed by implantation with Alcon Clareon Aspheric Hydrophobic Acrylic IOL or Alcon Clareon Aspheric Hydrophobic Acrylic Toric IOL, as indicated. The second eye surgery is recommended to occur within 14 days after the 1st eye surgery.
Phacoemulsification surgery, followed by implantation with TECNIS Eyhance IOL or TECNIS Eyhance Toric II IOL, as indicated. The second eye surgery is recommended to occur within 14 days after the 1st eye surgery.
Outcomes
Primary Outcome Measures
Mean binocular best-corrected distance visual acuity (BCDVA) at 4 meters
Visual Acuity will be tested at a distance of 4 meters using a refraction chart and the correction obtained from a manifest refraction. BCDVA will be measured in logarithm minimum angle of resolution (logMAR) units. 0.00 logMar equates to 20/20 Snellen and is considered normal distance eyesight. The eyes will be tested together.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05481125
Brief Title
Clareon Toric vs Eyhance Toric
Official Title
Clareon Toric vs Eyhance Toric
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 10, 2022 (Actual)
Primary Completion Date
October 16, 2023 (Actual)
Study Completion Date
October 16, 2023 (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.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary purpose of this study is to compare the Clareon/Clareon Toric Intraocular Lenses (IOLs) to the Eyhance/Eyhance Toric IOLs in binocular Best Corrected Distance Visual Acuity (BCDVA) at 3 months postoperative.
Detailed Description
This study will enroll adults 22 years of age and older diagnosed with cataracts in both eyes with planned bilateral cataract removal by routine small incision phacoemulsification surgery. Subjects will attend up to 7 scheduled visits: A screening visit, two operative visits, and four post-operative visits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Aphakia
Keywords
Cataracts, Phacoemulsification, IOL
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
182 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clareon/Clareon Toric
Arm Type
Experimental
Arm Description
Phacoemulsification surgery, followed by implantation with Alcon Clareon Aspheric Hydrophobic Acrylic IOL or Alcon Clareon Aspheric Hydrophobic Acrylic Toric IOL, as indicated. The second eye surgery is recommended to occur within 14 days after the 1st eye surgery.
Arm Title
Eyhance/Eyhance Toric
Arm Type
Active Comparator
Arm Description
Phacoemulsification surgery, followed by implantation with TECNIS Eyhance IOL or TECNIS Eyhance Toric II IOL, as indicated. The second eye surgery is recommended to occur within 14 days after the 1st eye surgery.
Intervention Type
Device
Intervention Name(s)
Clareon IOL
Other Intervention Name(s)
Model SY60WF
Intervention Description
Alcon Clareon Aspheric Hydrophobic Acrylic IOL for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed. The lens is indicated for primary implantation in the capsular bag in the posterior chamber of the eye, replacing the natural crystalline lens. IOLs are implantable medical devices and are intended for long-term use over the lifetime of the pseudophakic subject.
Intervention Type
Device
Intervention Name(s)
Clareon Toric IOL
Other Intervention Name(s)
Models CNW0T3, CNW0T4, CNW0T5, CNW0T6 as available
Intervention Description
Clareon Toric Aspheric Hydrophobic Acrylic Toric IOL for the visual correction of aphakia with pre-existing corneal astigmatism in adult patients in whom a cataractous lens has been removed. The lens is indicated for primary implantation in the capsular bag in the posterior chamber of the eye, replacing the natural crystalline lens. IOLs are implantable medical devices and are intended for long-term use over the lifetime of the pseudophakic subject.
Intervention Type
Device
Intervention Name(s)
Eyhance IOL
Other Intervention Name(s)
Model DIB00
Intervention Description
TECNIS Eyhance IOL with TECNIS Simplicity Delivery System for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag. IOLs are implantable medical devices and are intended for long-term use over the lifetime of the pseudophakic subject.
Intervention Type
Device
Intervention Name(s)
Eyhance Toric IOL
Other Intervention Name(s)
Models DIU150, DIU225, DIU300, DIU375 as available
Intervention Description
TECNIS Eyhance Toric II IOL with TECNIS Simplicity Delivery System for the visual correction of aphakia and pre-existing corneal astigmatism of one diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire reduction in residual refractive cylinder. The lens is intended to be placed in the capsular bag. IOLs are implantable medical devices and are intended for long-term use over the lifetime of the pseudophakic subject.
Intervention Type
Procedure
Intervention Name(s)
Phacoemulsification surgery
Intervention Description
Cataract removal by routine small incision phacoemulsification surgery
Primary Outcome Measure Information:
Title
Mean binocular best-corrected distance visual acuity (BCDVA) at 4 meters
Description
Visual Acuity will be tested at a distance of 4 meters using a refraction chart and the correction obtained from a manifest refraction. BCDVA will be measured in logarithm minimum angle of resolution (logMAR) units. 0.00 logMar equates to 20/20 Snellen and is considered normal distance eyesight. The eyes will be tested together.
Time Frame
Month 3 postoperative visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Planned bilateral cataract removal by routine small incision phacoemulsification surgery;
Planned implantation of either test or comparator IOL (per randomization) in at least one eye with approximately 1.00 - 3.00 diopter (D) of preoperative corneal astigmatism;
Predicted postoperative astigmatism of ≤ 0.5 D in both operative eyes based on a Toric calculator;
Other protocol-specified inclusion criteria may apply.
Key Exclusion Criteria:
Any disease or pathology, other than cataract, that (in the investigator's opinion) may reduce the potential BCDVA to a level worse than 0.2 logMAR;
Clinically significant (in the investigator's opinion) corneal pathology, dry-eye or ocular surface disease that would adversely affect a) the biometry measures and/or toric calculations and b) the visual outcome;
History of previous intraocular or corneal surgery (including laser-assisted in situ keratomileusis (LASIK));
Any other planned ocular surgical procedures including but not limited to limbal relaxing incision (LRI), astigmatic keratotomy, LASIK, and retinal laser treatment within the study time frame;
Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Lead, CDMA Surgical
Organizational Affiliation
Alcon Research, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Chu Vision Institute
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55420
Country
United States
Facility Name
Seeta Eye Centers
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12603
Country
United States
Facility Name
Cleveland Eye Clinic
City
Brecksville
State/Province
Ohio
ZIP/Postal Code
44141
Country
United States
Facility Name
Carolina Eyecare Physicians, LLC
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Vision for Life
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Texan Eye
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Houston Eye Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Berkeley Eye Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
Facility Name
Texas Eye Research Center
City
Hurst
State/Province
Texas
ZIP/Postal Code
76054
Country
United States
Facility Name
The Eye Institute of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Clareon Toric vs Eyhance Toric
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