NCT06064916

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Berkeley Eye Center · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

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

Conditions

• Pseudophakia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Visual Acuity	Monocular and binocular measurement of distance, intermediate, and near visual acuity
DIAGNOSTIC_TEST	Defocus Curve	Measurement of a defocus curve
OTHER	Intraocular Lens Satisfaction (IOLSAT) Questionnaire	Self-reported post-operative patient satisfaction with vision after surgery
OTHER	Quality of Vision After Surgery (QUVID) Questionnaire	Self-reported post-operative patient vision quality after surgery
OTHER	Visual Disturbance Questionnaire	Questionnaire of self-reported visual disturbances of patients
DIAGNOSTIC_TEST	Topography and Tomography	Topography and tomography measurements with Atlas, iTrace, and/or Pentacam

Timeline

• Start date: 2023-07-25
• Primary completion: 2024-12-11
• Completion: 2024-12-11
• First posted: 2023-10-03
• Last updated: 2025-05-23
• Results posted: 2025-05-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study