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

NCT ID: NCT05119127

Last Updated: 2021-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-30

Study Completion Date

2021-08-19

Brief Summary

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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

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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.

Conditions

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Cataract

Keywords

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Vivity Cataract Intraocular lens

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Alcon Vivity toric intra ocular lens

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role collaborator

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

UNKNOWN

Sponsor Role collaborator

Kevin Barber

OTHER

Sponsor Role lead

Responsible Party

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Kevin Barber

Ophthalmologist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Kevin Barber, MD

Role: PRINCIPAL_INVESTIGATOR

Ophthalmologist

Locations

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Central Florida Eye Specialists

DeLand, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36894823 (View on PubMed)

Other Identifiers

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63171943

Identifier Type: -

Identifier Source: org_study_id