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

Last updated: May 7, 2025
Sponsor: Berkeley Eye Center
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Intraocular Lens Satisfaction (IOLSAT) Questionnaire

Topography and Tomography

Visual Acuity

Clinical Study ID

NCT06064916
69865263
  • Ages > 40
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adults, 40 years of age having already undergone cataract removal byphacoemulsification with a clear corneal incision in both eyes with implantation ofthe 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 cataractpre-op visit

  3. Able to comprehend and willing to sign informed consent and complete all requiredtesting procedures

  4. Best Corrected Distance Visual Acuity (BCDVA) projected to be 0.10 logMAR (MinimumAngle 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 sphericalequivalent

Exclusion

Exclusion Criteria:

  1. Any corneal abnormality, other than regular corneal astigmatism or myopic LASIK/PRKsurgery, (as determined by pre-operative testing) that in the opinion of theinvestigator 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 orpredisposition 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.

  11. Subjects who have an acute or chronic disease or illness that would confound theresults of this investigation in the opinion of the principal investigator (e.g.immunocompromised, connective tissue disease, clinically significant atopic disease,etc)

Study Design

Total Participants: 20
Treatment Group(s): 6
Primary Treatment: Intraocular Lens Satisfaction (IOLSAT) Questionnaire
Phase:
Study Start date:
July 25, 2023
Estimated Completion Date:
December 11, 2024

Study 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

Connect with a study center

  • Berkeley Eye Center

    Houston, Texas 77027
    United States

    Site Not Available

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