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COMPLETED

Visual Outcomes and Patient Satisfaction With Vivity IOL in Post Refractive Patients

NCT06064916•Berkeley Eye Center

Summary

This is a non-interventional, prospective, observational study of the outcomes for post myopic refractive surgery patients following successful, uncomplicated cataract surgery with bilateral implantation of the Vivity IOL (DAT\*\*\*/CCWET\*). Patients will be assessed for monocular and binocular distance, intermediate, and near vision.

Detailed Description

This is a non-interventional, prospective, single center, bilateral, observational study of the outcomes for 40 post myopic refractive surgery patients following successful, uncomplicated cataract surgery with bilateral implantation of the Vivity IOL (DAT\*\*\*/CCWET\*) performed by 4 surgeons using similar surgical techniques. 40 subjects will be enrolled. Patients will be assessed for monocular and binocular distance, intermediate, and near vision. The hypothesis is that post-refractive patients that have high spherical aberration (SAs) will have excellent outcomes and satisfaction with a Vivity IOL

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Adults, 40 years of age having already undergone cataract removal by phacoemulsification with a clear corneal incision in both eyes with implantation of the Vivity IOL (DAT\*\*\*/CCWET\*)
•2. Prior uncomplicated, distance-targeted, bilateral myopic LASIK or PRK (photorefractive keratectomy) surgery and corneal spherical aberration greater than ≥0.30 μ and ≤ 1.20 μ in at least one eye (6.00 mm) as measured at their cataract pre-op visit
•3. Able to comprehend and willing to sign informed consent and complete all required testing procedures
•4. Best Corrected Distance Visual Acuity (BCDVA) projected to be 0.10 logMAR (Minimum Angle of Resolution) or better
•5. Clear intraocular media
•6. Minimum of two weeks post YAG (yttrium aluminum garnet) capsulotomy to treat PCO (posterior capsular opacification)
•7. Residual refractive astigmatism ≤0.50 diopters
•8. Post-operative refractive spherical equivalent from +0.50 to -0.50 spherical equivalent

Exclusion Criteria

•1. Any corneal abnormality, other than regular corneal astigmatism or myopic LASIK/PRK surgery, (as determined by pre-operative testing) that in the opinion of the investigator would confound the outcome(s) of the study
•2. Any complication during cataract surgery (capsular tear, vitrectomy, etc)
•3. History of or current retinal conditions or predisposition to retinal conditions or predisposition to retinal conditions
•4. Amblyopia or strabismus in either eye
•5. History of or current anterior or posterior segment inflammation of any etiology
•6. Any form of neovascularization on or within the eye
•7. Glaucoma (uncontrolled or controlled with medication)
•8. Optic nerve atrophy
•9. Subjects with diagnosed degenerative eye disorders
•10. Postoperative CDVA worse than 0.10 logMAR in either eye.
+1 more criteria

Locations (1)

Berkeley Eye Center

Houston, Texas, United States

Key Dates

Start Date

July 25, 2023

Primary Completion Date

December 11, 2024

Completion Date

December 11, 2024

Last Updated

May 23, 2025

Enrollment

ACTUAL participants

Conditions

Pseudophakia

Interventions

Visual Acuity

DIAGNOSTIC_TEST

Defocus Curve

DIAGNOSTIC_TEST

Intraocular Lens Satisfaction (IOLSAT) Questionnaire

OTHER

Quality of Vision After Surgery (QUVID) Questionnaire

OTHER

Visual Disturbance Questionnaire

OTHER

Topography and Tomography

DIAGNOSTIC_TEST

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PseudophakiaHypermetropia+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Visual Outcomes and Patient Satisfaction With Vivity IOL in Post Refractive Patients

Inclusion Criteria

Exclusion Criteria

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