Visual Acuity Outcome Differences Between the Alcon Vivity Toric IOL and RxSight LAL+
NCT ID: NCT06574646
Last Updated: 2024-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
250 participants
INTERVENTIONAL
2024-10-15
2026-08-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LAL+
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.
Clareon Vivity Toric IOLs
Clareon Vivity Toric IOL
Clareon Vivity Toric IOL utilizes an extended depth of focus (EDOF) design, which incorporates nondiffractive wavefront shaping (X-WAVE) technology.
Interventions
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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.
Clareon Vivity Toric IOL
Clareon Vivity Toric IOL utilizes an extended depth of focus (EDOF) design, which incorporates nondiffractive wavefront shaping (X-WAVE) technology.
Eligibility Criteria
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Inclusion Criteria
* All subjects will be required to be targeted for refractive emmetropia (plano or first minus closest to plano);
* Subjects will have an expected monocular BCDVA outcomes of 20/25 or better in the opinion of the investigator;
* Subjects will have regular corneal astigmatism (1.00 to 2.00 D), which can be corrected with a toric power IOL of T3-T5;
* Subjects will be required to have a dilated pupil diameter of 7 mm or greater in both eyes;
Exclusion Criteria
* Irregular astigmatism;
* Subject desire monovision correction;
* Preexisting macular disease or other retinal degenerative diseases that is expected to cause future vision loss;
* History of glaucoma;
* Severe dry eye disease;
* History of uveitis;
* History of ocular herpes simplex virus;
* History of nystagmus;
* Zonular laxity or dehiscence;
* History psueudoexfoliation;
* History of corneal refractive and intraocular surgery or requiring any other planned ocular surgical procedures;
* Currently taking systemic medication that may increase sensitivity to UV light or that may cause toxicity to the retina;
* Pregnant or breastfeeding.
45 Years
ALL
No
Sponsors
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The Eye Associates
OTHER
Responsible Party
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Cathleen McCabe MD
Medical Director
Principal Investigators
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Cathleen M McCabe, MD
Role: PRINCIPAL_INVESTIGATOR
The Eye Associates of Manatee
Locations
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The Eye Associates of Manatee, LLP
Bradenton, Florida, United States
Countries
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Central Contacts
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Alisha Polson
Role: CONTACT
Facility Contacts
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Other Identifiers
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A126-101
Identifier Type: -
Identifier Source: org_study_id
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