ILE871-P001 v1.0

• Research type

  Research Study

• Full title

  A Real World Evidence (RWE) ambispective study (Registry) to assess outcomes of Vivity and Vivity Toric (Non-Diffractive Extended Vision IOL) implantation.

• IRAS ID

  279509

• Contact name

  Inge Hansen

• Contact email

  inge.hansen@alcon.com

• Sponsor organisation

  Alcon Pharma GmbH

• Duration of Study in the UK

  1 years, 5 months, 1 days

• Research summary

  Research Summary:
  When a monofocal IOL is implanted during cataract surgery, patients have good distance vision, but vision at intermediate and near is often insufficient to support activities of daily living. In view of this, there exists a medical need to provide good vision at intermediate distances, while maintaining good distance vision and a visual disturbance profile similar to that of a monofocal IOL.

  The ACRYSOF Vivity and ACRYSOF Vivity Toric IOL was developed to provide an extended depth of vision at intermediate distance (approximately 66 cm) while maintaining distance visual acuity and a safety profile similar to that of the ACRYSOF IQ Monofocal IOL Model (SN60WF).

  This registry study will allow the collection of large sample size of subjects implanted with ACRYSOF Vivity and ACRYSOF Vivity Toric IOLs through around 50 sites in Europe, Australia and New Zealand.

  The study will be conducted at 7 private sites in the UK. 15-40 subjects per site are expected to be enrolled.

  All study visits, procedures and assessments will be performed as per the site's Standard of Care practice with the exception of 2 patient questionnaires that will be administered to patients for completion at follow up visit(s) (IOLSAT and Catquest-9SF).

  Summary of Results:
  A lay summary was not planned at time of trial initiation

• REC name

  West Midlands - South Birmingham Research Ethics Committee

• REC reference

  20/WM/0138

• Date of REC Opinion

  11 Jun 2020

• REC opinion

  Further Information Favourable Opinion