Cataract Clinical Trial
Official title:
Clareon Toric vs Eyhance Toric
Verified date | October 2023 |
Source | Alcon Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 182 |
Est. completion date | October 16, 2023 |
Est. primary completion date | October 16, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 22 Years and older |
Eligibility | 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 the potential BCDVA to a level worse than 0.2 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. |
Country | Name | City | State |
---|---|---|---|
United States | Texan Eye | Austin | Texas |
United States | Chu Vision Institute | Bloomington | Minnesota |
United States | Cleveland Eye Clinic | Brecksville | Ohio |
United States | Berkeley Eye Center | Houston | Texas |
United States | Houston Eye Associates | Houston | Texas |
United States | Texas Eye Research Center | Hurst | Texas |
United States | Carolina Eyecare Physicians, LLC | Mount Pleasant | South Carolina |
United States | Vision for Life | Nashville | Tennessee |
United States | Seeta Eye Centers | Poughkeepsie | New York |
United States | The Eye Institute of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
Alcon Research |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean binocular best-corrected distance visual acuity (BCDVA) at 4 meters | Visual Acuity will be tested at a distance of 4 meters using a refraction chart and the correction obtained from a manifest refraction. BCDVA will be measured in logarithm minimum angle of resolution (logMAR) units. 0.00 logMar equates to 20/20 Snellen and is considered normal distance eyesight. The eyes will be tested together. | Month 3 postoperative visit |
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