Clareon Toric vs Eyhance Toric
1 other identifier
interventional
203
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2022
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2022
CompletedFirst Posted
Study publicly available on registry
August 1, 2022
CompletedStudy Start
First participant enrolled
October 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 16, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 16, 2023
CompletedResults Posted
Study results publicly available
October 30, 2024
CompletedOctober 30, 2024
October 1, 2024
1 year
July 28, 2022
October 7, 2024
October 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Binocular Best-corrected Distance Visual Acuity (BCDVA) at 4 Meters Under Bright Lighting Conditions
Visual acuity was tested at a distance of 4 meters using a refraction chart and the correction obtained from a manifest refraction. BCDVA was measured in logarithm minimum angle of resolution (logMAR) units, with 0.00 logMar equating to 20/20 Snellen, which is considered normal distance eyesight. A lower logMAR value (more negative value) indicates better eyesight. This was a subject based assessment, and subject assigned a single score for both eyes.
Month 3 postoperative visit
Study Arms (2)
Clareon/Clareon Toric
EXPERIMENTALPhacoemulsification 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.
Eyhance/Eyhance Toric
ACTIVE COMPARATORPhacoemulsification 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.
Interventions
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.
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.
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.
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.
Cataract removal by routine small incision phacoemulsification surgery
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- Any disease or pathology, other than cataract, that (in the investigator's opinion) may reduce potential Best Corrected Distance Visual Acuity (BCDVA) to a level worse than 0.2 logarithm minimum angle of resolution (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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (8)
Seeta Eye Centers
Poughkeepsie, New York, 12603, United States
Cleveland Eye Clinic
Brecksville, Ohio, 44141, United States
Carolina Eyecare Physicians, LLC
Mt. Pleasant, South Carolina, 29464, United States
Vision for Life
Nashville, Tennessee, 37205, United States
Houston Eye Associates
Houston, Texas, 77008, United States
Berkeley Eye Center
Houston, Texas, 77027, United States
Texas Eye Research Center
Hurst, Texas, 76054, United States
The Eye Institute of Utah
Salt Lake City, Utah, 84107, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Clinical Projects, Surgical
- Organization
- Alcon Research, LLC
Study Officials
- STUDY DIRECTOR
Clinical Trial Lead, CDMA Surgical
Alcon Research, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2022
First Posted
August 1, 2022
Study Start
October 10, 2022
Primary Completion
October 16, 2023
Study Completion
October 16, 2023
Last Updated
October 30, 2024
Results First Posted
October 30, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share