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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05481125
Other study ID # ILS241-P002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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