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

Primary Purpose

Cataract

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Alcon Vivity toric intra ocular lens

About this trial

This is an interventional treatment trial for Cataract focused on measuring Vivity, Cataract, Intraocular lens

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

Central Florida Eye Specialists

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

vivity toric IOL implantation arm

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05119127

First Posted

November 5, 2021

Last Updated

November 5, 2021

Sponsor

Kevin Barber

Collaborators

Alcon Research, Eric Rosenberg, D.O.,M.Sc.Eng.

1. Study Identification

Unique Protocol Identification Number

NCT05119127

Brief Title

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

Official Title

The Purpose of This Research is to Assess Vivity Toric IOL Rotational Stability 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 With an Acrysof IQ Vivity Extended Vision Toric IOL.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

September 30, 2020 (Actual)

Primary Completion Date

May 5, 2021 (Actual)

Study Completion Date

August 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Kevin Barber

Collaborators

Alcon Research, Eric Rosenberg, D.O.,M.Sc.Eng.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract

Keywords

Vivity, Cataract, Intraocular lens

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

vivity toric IOL implantation arm

Arm Type

Experimental

Arm 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.

Intervention Type

Device

Intervention Name(s)

Alcon Vivity toric intra ocular lens

Intervention Description

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.

Primary Outcome Measure Information:

Title

Rotational stability of Vivity Toric IOL.

Description

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 Outcome Measure Information:

Title

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

Description

Time Frame

Five months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kevin Barber, MD

Organizational Affiliation

Ophthalmologist

Official's Role

Principal Investigator

Facility Information:

Facility Name

Central Florida Eye Specialists

City

DeLand

State/Province

Florida

ZIP/Postal Code

32720

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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