Rotational Stability of Acrysof IQ Vivity Extended Vision Toric IOL and Refractive Visual Outcome.

N/ACompletedNCT05119127

Kevin Barber35 enrolled

Overview

The purpose of this research is to assess the rotational stability of the AcrySof IQ Vivity Extended Vision Toric IOL and Refractive Visual outcome.

Assessment of the rotational stability and Refractive Visual Outcome of the AcrySof IQ Vivity Extended Vision Toric IOL at the end of surgery, post op 1 day, post op 1 week and post op 4 weeks. Participants in this research study are 45 years of age or older and have planned implantation in at least one eye.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cataract

Interventions

Alcon Vivity toric intra ocular lensDEVICE

implanting vivity toric IOL to asses rotational stability. IOL is already FDA approved for implantation at time of cataract surger. Intervention is to assess rotational stability and visual outcome.

Eligibility

Sex: ALLMin age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects undergoing cataract extraction with intraocular lens implantation. * Age: 45 years and older. * Willing and able to comply with scheduled visits and other study procedures. * Subjects who require an IOL power in the range of +15.0 D to +25.0 D. * Subjects with regular corneal astigmatism that can be treated with T3-T5. * Have good ocular health, with no pathology that compromises visual acuity (Outside of residual refractive error and cataract) * Potential postoperative visual acuity of 0.2 logMAR/ETDRS (20/32 Snellen) or better in both eyes. Exclusion Criteria: * Glaucoma. * Clinically significant corneal dystrophy. * Previous corneal refractive surgery (i.e LASIK, PRK, RK) * Pupil abnormalities. * Concurrent infectious/non-infectious uveitis. * History of chronic intraocular inflammation. * Visually significant macular disease. * History of retinal detachment.

Locations (1)

Central Florida Eye Specialists

DeLand, Florida, United States

Outcomes

Primary Outcomes

Rotational stability of Vivity Toric IOL.

Rotational stability of Vivity Toric IOL will be measured at post op 1 day, post op 1 week and post op 4 weeks.

Time frame: Five months

Secondary Outcomes

Percentage of eyes with residual refractive astigmatism, absolute residual astigmatism prediction error, and monocular distance and intermediate visual acuities.

Percentage of eyes with post op rotation of five degrees or less, absolute prediction of error ≤ 0.5 D, residual astigmatism ≤ 0.5 D, residual astigmatism 1.00 D. Monocular and Binocular UDVA, UIVA, UNVA, CDVA, DCIVA and DCNVA.

Time frame: Five months

Data from ClinicalTrials.gov

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