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

Sponsor

Kevin Barber (Other)

Overall Status

Completed

CT.gov ID

NCT05119127

Collaborator

Alcon Research (Industry), Eric Rosenberg, D.O.,M.Sc.Eng. (Other)

Enrollment

Location

Arm

10.6

Actual Duration (Months)

3.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: Alcon Vivity toric intra ocular lens	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention 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.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)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Sep 30, 2020

Actual Primary Completion Date :

May 5, 2021

Actual Study Completion Date :

Aug 19, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: vivity toric IOL implantation arm 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 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.

Arm

Intervention/Treatment

Experimental: vivity toric IOL implantation arm

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

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Central Florida Eye Specialists	DeLand	Florida	United States	32720

Sponsors and Collaborators

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

Investigators

Principal Investigator: Kevin Barber, MD, Ophthalmologist

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kevin Barber, Ophthalmologist, Central Florida Eye Specialists, LLC

ClinicalTrials.gov Identifier:

NCT05119127

Other Study ID Numbers:

63171943

First Posted:

Nov 12, 2021

Last Update Posted:

Nov 12, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

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.:

Keywords provided by Kevin Barber, Ophthalmologist, Central Florida Eye Specialists, LLC

Vivity

Cataract

Intraocular lens

Additional relevant MeSH terms:

Cataract

Study Results

No Results Posted as of Nov 12, 2021