Vivity IOL: Emmetropia Compared to Monovision.

Presbyopia Clinical Trial

Official title:

Visual Outcomes, Patient Satisfaction and Spectacle Independence Evaluation of the Acrysof® IQ Vivity® Intraocular Lens Targeted for Emmetropia or Nanovision.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05464732
• Other study ID #: CEP 20-002
• Status: Completed
• Phase: N/A
• Start date: September 3, 2020
• Est. completion date: August 30, 2022

Study information

• Verified date: October 2022
• Source: Carolina Eyecare Physicians, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Presbyopia

Intervention

Device:
• Vivity IOL
The Vivity IOL will be implanted bilaterally in all subjects.

Locations

Country	Name	City	State
United States	Carolina Eyecare Physicians, LLC	Mount Pleasant	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Carolina Eyecare Physicians, LLC	Science in Vision

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binocular uncorrected near (40 cm) visual acuity	The logMAR binocular uncorrected visual acuity at 40 cm will be measured.	3 months