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Clareon Toric vs Eyhance Toric | Clinical Trials | Clareo Health

COMPLETEDNA

Clareon Toric vs Eyhance Toric

NCT05481125•Alcon Research

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. The expected individual duration of participation in the study is 3 months.

Eligibility

Age

22 - No limit years

Sex

ALL

Healthy Volunteers

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;

Exclusion Criteria

•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;

Locations (8)

Seeta Eye Centers

Poughkeepsie, New York, United States

Cleveland Eye Clinic

Brecksville, Ohio, United States

Carolina Eyecare Physicians, LLC

Mt. Pleasant, South Carolina, United States

Vision for Life

Nashville, Tennessee, United States

Houston Eye Associates

Houston, Texas, United States

Berkeley Eye Center

Houston, Texas, United States

Texas Eye Research Center

Hurst, Texas, United States

The Eye Institute of Utah

Salt Lake City, Utah, United States

Key Dates

Start Date

October 10, 2022

Primary Completion Date

October 16, 2023

Completion Date

October 16, 2023

Last Updated

October 30, 2024

Enrollment

203

ACTUAL participants

Conditions

CataractAphakia

Interventions

Clareon IOL

DEVICE

Clareon Toric IOL

DEVICE

Eyhance IOL

DEVICE

Eyhance Toric IOL

DEVICE

Phacoemulsification surgery

PROCEDURE

Efficacy and Safety of Tran Cannula in Combined Pseudoexfoliative Glaucoma and Cataract Surgery Compared With Augmented Ocular Irrigation

NCT06979752

Glaucoma, Open Angle, Pseudo-exfoliativeCataract

View study

RECRUITING

Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery (Post-market Study)

NCT07362043

Cataract Surgery

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 30, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clareon Toric vs Eyhance Toric

Inclusion Criteria

Exclusion Criteria

Efficacy and Safety of Tran Cannula in Combined Pseudoexfoliative Glaucoma and Cataract Surgery Compared With Augmented Ocular Irrigation

Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery (Post-market Study)

IC-8 Apthera IOL New Enrollment Post Approval Study

HUD Surgical Guidance for Toric Alignment

PRO-232 in Patients Subjected to Cataract Surgery

Outcomes of Clareon PanOptix Pro in Patients With Prior Myopic Refractive Surgery