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

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Device: Alcon Vivity toric intra ocular lens

• Registration Number: NCT05119127
• Lead Sponsor: Kevin Barber

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2020-09-30
• Primary Completion: 2021-05-05
• Study Completion: 2021-08-19
• Status Verified: 2021-11
• Study First Submitted: 2021-11-05
• Study First Submitted QC: 2021-11-05
• Last Update Submitted: 2021-11-05
• Study First Posted: 2021-11-12
• Last Update Posted: 2021-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
vivity toric IOL implantation arm	Alcon Vivity toric intra ocular lens	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Percentage of eyes with residual refractive astigmatism, absolute residual astigmatism prediction error, and monocular distance and intermediate visual acuities.	Five months	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.

Trial Locations

Locations (1)

Central Florida Eye Specialists; 🇺🇸 DeLand, Florida, United States