Clareon Toric vs Eyhance Toric

Not Applicable

Completed

• Conditions: Cataract; Aphakia
• Interventions: Device: Clareon IOL; Device: Eyhance IOL; Device: Eyhance Toric IOL; Device: Clareon Toric IOL; Procedure: Phacoemulsification surgery

• Registration Number: NCT05481125
• Lead Sponsor: Alcon Research

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

Study Timeline

• Study First Submitted: 2022-07-28
• Study First Submitted QC: 2022-07-28
• Study First Posted: 2022-08-01
• Study Start: 2022-10-10
• Primary Completion: 2023-10-16
• Study Completion: 2023-10-16
• Status Verified: 2024-10
• Results First Submitted: 2024-10-07
• Results First Submitted QC: 2024-10-07
• Last Update Submitted: 2024-10-07
• Results First Posted: 2024-10-30
• Last Update Posted: 2024-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

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 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;
• Other protocol-specified exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clareon/Clareon Toric	Clareon IOL	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.
Eyhance/Eyhance Toric	Eyhance Toric IOL	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.
Clareon/Clareon Toric	Clareon Toric IOL	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.
Clareon/Clareon Toric	Phacoemulsification surgery	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.
Eyhance/Eyhance Toric	Phacoemulsification 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.
Eyhance/Eyhance Toric	Eyhance IOL	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.

Primary Outcome Measures

Name	Time	Method
Mean Binocular Best-corrected Distance Visual Acuity (BCDVA) at 4 Meters Under Bright Lighting Conditions	Month 3 postoperative visit	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.

Trial Locations

Locations (8)

Seeta Eye Centers; 🇺🇸 Poughkeepsie, New York, United States

Cleveland Eye Clinic; 🇺🇸 Brecksville, Ohio, United States

Carolina Eyecare Physicians, LLC; 🇺🇸 Mount 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