Clinical trial NCT05481125: Clareon Toric vs Eyhance Toric
Official title: Clareon Toric vs Eyhance Toric
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Aphakia
Keywords: Cataracts
Phacoemulsification
IOL
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2022-08-01
Enrollment: 203
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Mean Binocular Best-corrected Distance Visual Acuity (BCDVA) at 4 Meters Under Bright Lighting Conditions
timeFrame: Month 3 postoperative visit
Secondary outcomes:
Other outcomes:
Locations:
city: Poughkeepsie
country: United States
facility: Seeta Eye Centers
state: New York
city: Brecksville
country: United States
facility: Cleveland Eye Clinic
state: Ohio
city: Mount Pleasant
country: United States
facility: Carolina Eyecare Physicians, LLC
state: South Carolina
city: Nashville
country: United States
facility: Vision for Life
state: Tennessee
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
city: Houston
country: United States
facility: Berkeley Eye Center
state: Texas
city: Hurst
country: United States
facility: Texas Eye Research Center
state: Texas
city: Salt Lake City
country: United States
facility: The Eye Institute of Utah
state: Utah
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, CDMA Surgical
role: STUDY_DIRECTOR
References: