Clareon Toric vs Eyhance Toric

Alcon

Status: Completed

Conditions: Cataract; Aphakia

Treatments: Procedure: Phacoemulsification surgery; Device: Clareon IOL; Device: Eyhance Toric IOL; Device: Clareon Toric IOL; Device: Eyhance IOL

Study type: Interventional

Funder types: Industry

Identifiers

NCT05481125

ILS241-P002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 203 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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203 participants in 2 patient groups

Clareon/Clareon Toric

Experimental group

Description:

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.

Treatment:

Device: Clareon Toric IOL

Device: Clareon IOL

Procedure: Phacoemulsification surgery

Eyhance/Eyhance Toric

Active Comparator group

Description:

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.

Treatment:

Device: Eyhance IOL

Device: Eyhance Toric IOL

Procedure: Phacoemulsification surgery