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NCT06541795 | NOT YET RECRUITING | Aphakia

Evaluation of AcrySof IQ Vivity Extended Vision Intraocular Lenses
Sponsor:

Alcon Research

Brief Summary:

The purpose of this post-market study is to describe the long-term safety and performance of AcrySof IQ Vivity and AcrySof IQ Vivity Toric intraocular lens (IOL) models in a real-world setting through routine clinical practice.

Condition or disease

Aphakia

Presbyopia

Residual Refractive Cylinder

Intervention/treatment

AcrySof IQ Vivity Extended Vision IOL

Phase

NA

Detailed Description:

This study includes a retrospective chart review to obtain preoperative, operative, and post-operative data, and one prospective visit to collect key long-term safety and performance endpoints in a sample of subjects commercially implanted with the specified IOLs for 3 to 5 years in the real world. This study will be conducted in the US and in Spain.

Study Type : INTERVENTIONAL
Estimated Enrollment : 210 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Evaluation of Long-term Safety and Performance of AcrySof IQ Vivity Extended Vision and AcrySof IQ Vivity Toric Extended Vision Intraocular Lenses
Actual Study Start Date : 2025-06
Estimated Primary Completion Date : 2026-12
Estimated Study Completion Date : 2026-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 22 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Key Inclusion Criteria
  • * 22 years old or older at Visit 1.
  • * Able to understand and sign an approved informed consent form.
  • * Implantation of AcrySof IQ Vivity and/or Vivity Toric IOL models in both eyes for 3 to 5 years prior to enrollment.
  • * Documented medical history and required pre-operative baseline information available for retrospective data collection.
  • * Other protocol-specified inclusion criteria may apply.
  • Key Exclusion Criteria
    • * Corneal refractive surgery after AcrySof Vivity or AcrySof Vivity Toric IOL implantation.
    • * Pregnant or nursing at the time of enrollment.
    • * Childbirth after IOL implantation.
    • * Other protocol-specified exclusion criteria may apply.
Evaluation of AcrySof IQ Vivity Extended Vision Intraocular Lenses

Location Details

NCT06541795

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Texas

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States, 76134