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

NCT06064916 | Completed Results FDA Device

• 1 other identifier: 69865263
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pseudophakia

Keywords

Vivity; Pseudophakia

Outcome Measures

Primary Outcomes (1)

• Binocular Best Corrected Distance Visual Acuity

  Binocular Best Corrected Distance Visual Acuity in logMAR

  3 weeks post operatively

Secondary Outcomes (5)

• Monocular Visual Acuity

  3 weeks post operatively

• Binocular Distance, Intermediate, and Near Visual Acuity

  3 weeks post operatively

• Quality of Vision After Surgery (QUVID) Questionnaire

  3 weeks post operatively

• Intraocular Lens Satisfaction (IOLSAT) Questionnaire

  3 weeks post operatively

• Post-op Refraction

  3 weeks post operatively

Other Outcomes (2)

• Binocular Defocus Curve

  3 weeks post operatively

• Spectacle Independence (IOLSAT)

  3 weeks post operatively

Study Arms (1)

Vivity IOL Group

Patients with bilateral implantation of Vivity IOLs.

Diagnostic Test: Visual Acuity; Diagnostic Test: Defocus Curve; Other: Intraocular Lens Satisfaction (IOLSAT) Questionnaire; Other: Quality of Vision After Surgery (QUVID) Questionnaire; Other: Visual Disturbance Questionnaire; Diagnostic Test: Topography and Tomography

Interventions

Visual Acuity DIAGNOSTIC_TEST

Monocular and binocular measurement of distance, intermediate, and near visual acuity

Vivity IOL Group

Defocus Curve DIAGNOSTIC_TEST

Measurement of a defocus curve

Vivity IOL Group

Intraocular Lens Satisfaction (IOLSAT) Questionnaire OTHER

Self-reported post-operative patient satisfaction with vision after surgery

Vivity IOL Group

Quality of Vision After Surgery (QUVID) Questionnaire OTHER

Self-reported post-operative patient vision quality after surgery

Vivity IOL Group

Visual Disturbance Questionnaire OTHER

Questionnaire of self-reported visual disturbances of patients

Vivity IOL Group

Topography and Tomography DIAGNOSTIC_TEST

Topography and tomography measurements with Atlas, iTrace, and/or Pentacam

Vivity IOL Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with healthy eyes, prior myopic LASIK or PRK with SA greater than 0.3, and uncomplicated bilateral implantation of the Vivity IOL (DAT\*\*\*/CCWET\*).

You may qualify if:

• 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\*)
• 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
• Able to comprehend and willing to sign informed consent and complete all required testing procedures
• Best Corrected Distance Visual Acuity (BCDVA) projected to be 0.10 logMAR (Minimum Angle of Resolution) or better
• Clear intraocular media
• Minimum of two weeks post YAG (yttrium aluminum garnet) capsulotomy to treat PCO (posterior capsular opacification)
• Residual refractive astigmatism ≤0.50 diopters
• Post-operative refractive spherical equivalent from +0.50 to -0.50 spherical equivalent

You may not qualify if:

• 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
• Any complication during cataract surgery (capsular tear, vitrectomy, etc)
• History of or current retinal conditions or predisposition to retinal conditions or predisposition to retinal conditions
• Amblyopia or strabismus in either eye
• History of or current anterior or posterior segment inflammation of any etiology
• Any form of neovascularization on or within the eye
• Glaucoma (uncontrolled or controlled with medication)
• Optic nerve atrophy
• Subjects with diagnosed degenerative eye disorders
• Postoperative CDVA worse than 0.10 logMAR in either eye.
• Subjects who have an acute or chronic disease or illness that would confound the results of this investigation in the opinion of the principal investigator (e.g. immunocompromised, connective tissue disease, clinically significant atopic disease, etc)

Sponsors & Collaborators

• Berkeley Eye Center: lead

Study Sites (1)

Berkeley Eye Center

Houston, Texas, 77027, United States

Location

MeSH Terms

Conditions

Pseudophakia

Interventions

Visual Acuity; Surveys and Questionnaires; Tomography

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vision Tests; Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Ocular Physiological Phenomena; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Diagnostic Imaging

Results Point of Contact

• Title: Tetiana Huff
• Organization: Berkeley Eye Center

tetiana.huff@berkeleyeye.com

713-620-7640

Study Officials

• Morgan Micheletti, MD

  Berkeley Eye Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: October 3, 2023
• Study Start: July 25, 2023
• Primary Completion: December 11, 2024
• Study Completion: December 11, 2024
• Last Updated: May 23, 2025
• Results First Posted: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)