Clareon TruPlus IOLs in Bilateral Cataract Surgery
Official title: Clareon TruPlus Single-Arm Study
Run by Alcon Research · NCT07502456 · Data updated 2026-11-12
This study tests Clareon TruPlus Monofocal IOLs to see how safe they are and how well they perform for people with both eyes affected by cataracts.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 22 Years and up |
| Sex | All |
| Enrollment | 185 (estimated) |
| Sponsor | Alcon Research Industry-sponsored |
| Locations | 5 sites (Phoenix, Arizona and 4 other locations) |
| Status | Recruiting |
| Started | May 26, 2026 |
| Main results expected | June 2028 |
| Study ends | June 2028 |
| Registry record updated | October 30, 2026 |
| Trial ID | NCT07502456 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with bilateral cataracts planning bilateral cataract extraction and toric or non-toric IOL needs, as judged suitable by an investigator.
✕Probably not a fit
Patients with exclusion criteria such as AMD, glaucoma, or significant dry eye that could affect measurements may not benefit from the device or study outcomes.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study implants Clareon TruPlus Monofocal intraocular lenses (IOLs) during cataract surgery to gather safety and performance data. Participants may receive either non-toric or toric IOLs based on an IOL calculator recommendation. The study involves eight visits over about 13 months, including preoperative, two surgical, and five postoperative visits, with the second-eye surgery typically 0–14 days after the first. Key eligibility targets adults with bilateral cataracts and acceptable best-corrected vision, while excluding eyes with certain retinal or ocular conditions that could affect measurements. Phacoemulsification is the surgical method used, and all procedures are conducted at multiple clinical sites under the lead sponsor Alcon Research.
Why it matters
Potential benefit: If successful, participants may experience safe implantation of Clareon TruPlus IOLs with potential for improved or stable vision after cataract surgery.
How similar studies have gone: Prior studies of Clareon TruPlus or similar IOLs have shown favorable safety and performance in cataract patients, supporting this type of evaluation, though specifics depend on device and population.
Who can join: the full rules
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Diagnosed with bilateral cataracts and planned bilateral cataract extraction by routine phacoemulsification. * Potential postoperative BCDVA of 0.2 logMAR or better in each eye in the expert medical opinion of the investigator. * Astigmatism suitable for correction with available toric IOL models. * Other protocol-specified inclusion criteria may apply. Key Exclusion Criteria: * Age-related macular degeneration (AMD), glaucoma, diabetic retinopathy, and other eye conditions as specified in the protocol. * Moderate to severe dry eye that would affect study measurements. * Other protocol-specified exclusion criteria may apply.
Where it's running
-
Eye Doctors of Arizona
Phoenix, Arizona, United States Recruiting -
Cleveland Eye Clinic
Brecksville, Ohio, United States Recruiting -
Carolina Eyecare Physicians LLC
Mt. Pleasant, South Carolina, United States Recruiting -
Berkeley Eye Center
Sugar Land, Texas, United States Recruiting -
The Eye Institute of Utah
Salt Lake City, Utah, United States Recruiting
Study contacts
- Study coordinator: Alcon Call Center
- Email: alcon.medinfo@alcon.com
- Phone: 1-888-451-3937
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Two monthly silicone hydrogel multifocal toric contact lenses in wearers with astigmatism and myopia
This study tests whether two popular soft multifocal toric contact lenses perform differently in adults who need vision correction for astigmatism and myopia.
-
Seeing clearly in low light after Ray-Tracing guided LASIK
A trial tests how well WaveLight Plus LASIK works for people with myopia and astigmatism and whether patients are satisfied after the procedure.
-
Orthokeratology contact lenses with a 5 mm optic zone diameter
This study tests Paragon CRT lenses with a 5 mm optic zone in kids and young adults to see how well they fit, how well they vision, and how comfortable they are at night.
-
Corneal Biomechanics and Surgical Astigmatism after Cataract Surgery in Pseudoexfoliation
This study tests how the cornea's biomechanical properties before cataract surgery relate to the amount of blinking surgically induced astigmatism, comparing people with pseudoexfoliation to those without.
-
SMILE in one eye vs Ray tracing-guided LASIK in the fellow eye
This study tests two laser vision correction methods—SMILE in one eye and ray-tracing guided LASIK in the other eye—to see which provides better vision and quality of life for adults with myopia and astigmatism.
-
Nomogram for Astigmatism Correction of KLEx
This study tests whether using a nomogram can improve outcomes after astigmatism correction in adults who meet certain eye health criteria.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.