Trials / Not Yet Recruiting
Not Yet RecruitingNCT06574646
Visual Acuity Outcome Differences Between the Alcon Vivity Toric IOL and RxSight LAL+
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- Sponsor
- The Eye Associates · Academic / Other
- Sex
- All
- Age
- 45 Years
- Healthy volunteers
- Not accepted
Summary
Phase 1 will be ambispective, multi-site, single arm study in age-related cataract patients with regular astigmatism, who were bilaterally treated with the LAL+ IOLs Phase 2 will be a prospective, randomized, unmasked, comparative, multi-site study with 90 days of follow up. Subjects will be randomized in a 1:1 manner to LAL+ or Clareon VIvity Toric IOLs.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | LAL+ | LAL+ IOL allows for refractive error (both sphere and cylinder) enhancements post-IOL implantation by exposing the IOL to ultraviolet (UV) light through a series of noninvasive treatments with a Light Delivery Device. |
| DEVICE | Clareon Vivity Toric IOL | Clareon Vivity Toric IOL utilizes an extended depth of focus (EDOF) design, which incorporates nondiffractive wavefront shaping (X-WAVE) technology. |
Timeline
- Start date
- 2024-10-15
- Primary completion
- 2026-02-01
- Completion
- 2026-08-01
- First posted
- 2024-08-28
- Last updated
- 2024-08-28
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06574646. Inclusion in this directory is not an endorsement.