Clareon Toric vs Eyhance Toric (NCT05481125) | Clinical Trial Compass
CompletedNot Applicable
Clareon Toric vs Eyhance Toric
United States203 participantsStarted 2022-10-10
Plain-language 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.
Who can participate
Age range22 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Mean Binocular Best-corrected Distance Visual Acuity (BCDVA) at 4 Meters Under Bright Lighting Conditions