Clareon Toric vs Eyhance Toric

Cataract Clinical Trial

Official title:

Clareon Toric vs Eyhance Toric

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05481125
• Other study ID #: ILS241-P002
• Status: Completed
• Phase: N/A
• Start date: October 10, 2022
• Est. completion date: October 16, 2023

Study information

• Verified date: October 2023
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: October 16, 2023
• Est. primary completion date: October 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aphakia
• Cataract

Intervention

Device:
• Clareon IOL
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 IOL
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.
• Eyhance IOL
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.
• Eyhance Toric IOL
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.

Procedure:
• Phacoemulsification surgery
Cataract removal by routine small incision phacoemulsification surgery

Locations

Country	Name	City	State
United States	Texan Eye	Austin	Texas
United States	Chu Vision Institute	Bloomington	Minnesota
United States	Cleveland Eye Clinic	Brecksville	Ohio
United States	Berkeley Eye Center	Houston	Texas
United States	Houston Eye Associates	Houston	Texas
United States	Texas Eye Research Center	Hurst	Texas
United States	Carolina Eyecare Physicians, LLC	Mount Pleasant	South Carolina
United States	Vision for Life	Nashville	Tennessee
United States	Seeta Eye Centers	Poughkeepsie	New York
United States	The Eye Institute of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Month 3 postoperative visit