Post-market clinical follow-up study – Retrospective evaluation of endothelial cell density and IOL explants related to the clinical use of AcrySof® CACHET® Phakic Lens in three European countries

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/14318
• EU PAS number:
  EUPAS5584
• Study ID:
  14318
• Official title and acronym:
  Post-market clinical follow-up study – Retrospective evaluation of endothelial cell density and IOL explants related to the clinical use of AcrySof® CACHET® Phakic Lens in three European countries
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Spain
• Study description:
  This is a post-market clinical follow-up study to evaluate endothelial cell density (ECD) and intraocular lens explants related to the clinical use of AcrySof® CACHET® Phakic Lens, for the correction of myopia, in three European countries: Spain, France and Germany. Phakic anterior chamber implants are used for the correction of myopia or hypermetropia. Loss of endothelial cells of the cornea may cause clouding of the cornea and blurred vision, in some cases leading to explants.This study aims to capture data on ECD in a real-life setting and to quantify the frequency of ECL and AcrySof® CACHET® Phakic Lens explants. This study has a retrospective cohort design. It will include patients implanted with AcrySof® CACHET® Phakic Lens between 2008 and 2013. Sites from Germany, Spain, and France will be selected. In each country, a lead investigator will be recruited to centralize and help organize the research effort in the country. Information from patient medical records will be collected through an online electronic data capture platform (one file per implanted eye), and preoperative (demographics, ECD measurements, among others) and postoperative (ECD measurements and explants information) data will be abstracted. The mean and standard deviation of ECD at the last preoperative visit and each month after surgery will be provided. Counts and percentages, with the corresponding 95% confidence intervals, of the following outcomes will be provided: acute ECL, chronic ECL, explants of AcrySof® CACHET® Phakic Lens ≤ 6 months after implant, and explants of AcrySof® CACHET® Phakic Lens > 6 months of implant.
• Study status:
  Finalised

Research institutions and networks

Institutions

RTI Health Solutions (RTI-HS)

France

Spain

Sweden

United Kingdom

United Kingdom (Northern Ireland)

United States

Kantar Health

Kantar Health GmbH Germany, Clinics France, Clinics Germany, Clinics Spain

Study timelines

Date when funding contract was signed

Planned: 01/07/2013

Actual: 22/07/2013

Study start date

Planned: 15/06/2014

Actual: 22/07/2014

Data analysis start date

Planned: 01/11/2014

Actual: 27/11/2014

Date of final study report

Planned: 08/05/2015

Actual: 21/05/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Alcon Labs, Inc.

Study protocol

Initial protocol

Cachet Protocol Redacted

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable