N/A
N=175
Clareon Toric vs Eyhance Toric
Cataract · Aphakia
Bottom Line
View on ClinicalTrials.gov: NCT05481125 ↗Enrolled (actual)
175
Serious AEs
1.3%
Results posted
Oct 2024
Primary outcome: Primary: Mean Binocular Best-corrected Distance Visual Acuity (BCDVA) at 4 Meters Under Bright Lighting Conditions — -0.100; -0.055 logMAR
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Clareon IOL (Device); Clareon Toric IOL (Device); Eyhance IOL (Device); Eyhance Toric IOL (Device); Phacoemulsification surgery (Procedure)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Binocular Best-corrected Distance Visual Acuity (BCDVA) at 4 Meters Under Bright Lighting Conditions |
-0.100; -0.055 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT05481125). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.