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

Kevin Barber

Status: Completed

Conditions: Cataract

Treatments: Device: Alcon Vivity toric intra ocular lens

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05119127

63171943

Details and patient eligibility

About

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

Full description

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.

Enrollment: 35 patients

Sex: All

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

vivity toric IOL implantation arm

Experimental group

Description:

vivity toric intraocular lens will be implanted in one eye and undergo digital imaging intra op and post op to evaluate for toric intraocular lens rotational stability.

Treatment:

Device: Alcon Vivity toric intra ocular lens