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Vivity IOL: Emmetropia Compared to Monovision.

Primary Purpose

Presbyopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vivity IOL
Sponsored by
Carolina Eyecare Physicians, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Presbyopia

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects must fulfill the following conditions to qualify for enrollment into the trial

  1. Subject is undergoing bilateral lens extraction with intraocular lens implantation.
  2. Gender: Males and Females.
  3. Age: 50 years and older.
  4. Willing and able to provide written informed consent for participation in the study
  5. Willing and able to comply with scheduled visits and other study procedures.
  6. Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 6 to 30 days between surgeries
  7. Subjects who require an IOL power in the range of +15.0 D to +25.0 D only.
  8. Subjects who require a toric IOL up to +3.00 D at the IOL plane (2.06 D corneal plane).
  9. Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.

Exclusion Criteria:

Subjects with any of the following conditions on the eligibility exam may not be enrolled into the trial.

  1. Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmos or macrophthalmos, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.
  2. Uncontrolled diabetes.
  3. Use of any systemic or topical drug known to interfere with visual performance.
  4. Contact lens use during the active treatment portion of the trial.
  5. Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
  6. Clinically significant corneal dystrophy
  7. History of chronic intraocular inflammation.
  8. History of retinal detachment.
  9. Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
  10. Previous intraocular surgery.
  11. Previous corneal refractive surgery (i.e. laser-assisted in situ keratomileusis, photorefractive keratectomy, radial keratotomy).
  12. Previous keratoplasty
  13. Severe dry eye
  14. Pupil abnormalities
  15. Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc).
  16. Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results.
  17. Participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial.

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates the patient is unsuitable for the trial.

Sites / Locations

  • Carolina Eyecare Physicians, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Monovision

Emmetropia

Arm Description

The target refraction is plano (0.00 D) for the dominant eye and between -0.50 D and -0.75 D for the non-dominant eye. The Vivity IOL will be implanted bilaterally. Corrected vision will involve correcting the dominant eye for emmetropia and the non-dominant eye for -0.50 D.

Subject's vision will be tested with both eyes corrected for emmetropia.

Outcomes

Primary Outcome Measures

Binocular uncorrected near (40 cm) visual acuity
The logMAR binocular uncorrected visual acuity at 40 cm will be measured.

Secondary Outcome Measures

Full Information

First Posted
July 18, 2022
Last Updated
October 4, 2022
Sponsor
Carolina Eyecare Physicians, LLC
Collaborators
Science in Vision
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1. Study Identification

Unique Protocol Identification Number
NCT05464732
Brief Title
Vivity IOL: Emmetropia Compared to Monovision.
Official Title
Visual Outcomes, Patient Satisfaction and Spectacle Independence Evaluation of the Acrysof® IQ Vivity® Intraocular Lens Targeted for Emmetropia or Nanovision.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 3, 2020 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carolina Eyecare Physicians, LLC
Collaborators
Science in Vision

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Current visual outcomes expectations of cataract patients are similar to those of refractive surgery patients. Their desire is to be spectacle independent for far, intermediate and near vision activities. Different options are available including: mono-vision and presbyopia correcting intraocular lenses (IOL). Presbyopia correcting IOLs include accommodative, multifocal, trifocal and extended depth of focus (EDOF) IOLs. The Vivity Extended Vision IOL is not a multifocal IOL but due to its design, it provides better intermediate and near VA compared to a monofocal IOL.
Detailed Description
The study is concerned with the visual performance of the Vivity Extended Vision IOL at distance, intermediate and near when one of the eyes is targeted for emmetropia and the other is targeted for slight myopia. Patients will serve as their own controls with visual performance evaluated against corrected vision with a target of emmetropia in both eyes.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Monovision
Arm Type
Experimental
Arm Description
The target refraction is plano (0.00 D) for the dominant eye and between -0.50 D and -0.75 D for the non-dominant eye. The Vivity IOL will be implanted bilaterally. Corrected vision will involve correcting the dominant eye for emmetropia and the non-dominant eye for -0.50 D.
Arm Title
Emmetropia
Arm Type
Active Comparator
Arm Description
Subject's vision will be tested with both eyes corrected for emmetropia.
Intervention Type
Device
Intervention Name(s)
Vivity IOL
Intervention Description
The Vivity IOL will be implanted bilaterally in all subjects.
Primary Outcome Measure Information:
Title
Binocular uncorrected near (40 cm) visual acuity
Description
The logMAR binocular uncorrected visual acuity at 40 cm will be measured.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects must fulfill the following conditions to qualify for enrollment into the trial Subject is undergoing bilateral lens extraction with intraocular lens implantation. Gender: Males and Females. Age: 50 years and older. Willing and able to provide written informed consent for participation in the study Willing and able to comply with scheduled visits and other study procedures. Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 6 to 30 days between surgeries Subjects who require an IOL power in the range of +15.0 D to +25.0 D only. Subjects who require a toric IOL up to +3.00 D at the IOL plane (2.06 D corneal plane). Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes. Exclusion Criteria: Subjects with any of the following conditions on the eligibility exam may not be enrolled into the trial. Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmos or macrophthalmos, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc. Uncontrolled diabetes. Use of any systemic or topical drug known to interfere with visual performance. Contact lens use during the active treatment portion of the trial. Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis. Clinically significant corneal dystrophy History of chronic intraocular inflammation. History of retinal detachment. Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules. Previous intraocular surgery. Previous corneal refractive surgery (i.e. laser-assisted in situ keratomileusis, photorefractive keratectomy, radial keratotomy). Previous keratoplasty Severe dry eye Pupil abnormalities Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc). Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results. Participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial. The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates the patient is unsuitable for the trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerry Solomon
Organizational Affiliation
Carolina Eyecare Physicians, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carolina Eyecare Physicians, LLC
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Vivity IOL: Emmetropia Compared to Monovision.

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