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

NCT05119127 | Completed

• 1 other identifier: 63171943
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Keywords

Vivity; Cataract; Intraocular lens

Outcome Measures

Primary Outcomes (1)

• 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.

  Five months

Secondary Outcomes (1)

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

  Five months

Study Arms (1)

vivity toric IOL implantation arm

EXPERIMENTAL

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.

Device: Alcon Vivity toric intra ocular lens

Interventions

Alcon Vivity toric intra ocular lens DEVICE

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.

vivity toric IOL implantation arm

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kevin Barber: lead
• Alcon Research: collaborator
• Eric Rosenberg, D.O.,M.Sc.Eng.: collaborator

Study Sites (1)

Central Florida Eye Specialists

DeLand, Florida, 32720, United States

Location

Related Publications (1)

• Barber KM, O'Connor S, Mackinder P, Chih A, Jones B. Rotational stability and refractive outcomes of the DFT/DATx15 toric, extended depth of focus intraocular lens. Int Ophthalmol. 2023 Aug;43(8):2737-2747. doi: 10.1007/s10792-023-02673-7. Epub 2023 Mar 10.

  PMID: 36894823 DERIVED

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Kevin Barber, MD

  Ophthalmologist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ophthalmologist

Model Details: Study will include adults (45 years and older) who plan to have cataract extraction and subsequent implantation of AcrySof® IQ Vivity™Extended Vision Toric IOL in at least one eye. Approximately 40 eye will be screened to identify 35 qualified eyes. Within 40 days of screening, qualified subjects will receive cataract surgery followed by implantation of the AcrySof® IQ Vivity™Extended Vision Toric IOL at the surgery visit. If the second eye will participate in the study, subjects will receive the second eye cataract surgery within 60 days of the Screening visit 0. Four postoperative follow up visits are planned to occur at 1-2 days, 7-14 days, and 28-35 days for each enrolled eye. Subject participation in this study is expected to last up to 2 months, including a total of 5 study visits for subjects implanted in one eye and up to 9 visits for subjects implanted in both eyes. Upon completion of the 35 day follow up visit subjects will be exited from the study.

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: November 12, 2021
• Study Start: September 30, 2020
• Primary Completion: May 5, 2021
• Study Completion: August 19, 2021
• Last Updated: November 12, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)