Status: Finalised First registered on: 17/01/2014
Last updated on: 22/07/2016
1. Study identification
EU PAS Register NumberEUPAS5584
Official titlePost-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 title acronym
Study typeObservational study
Brief description of the studyThis 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.
Was this study requested by a regulator?Yes: France
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsRTI-HS
Department/Research groupPharmacoepidemiology & Risk Management
Organisation/affiliationRTI Health Solutions
Website/Homepagewww.rtihs.org
Details of (Primary) lead investigator
Title Dr
Last name Arana
First name Alejandro
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?7

RTI-HS
Kantar Health GmbH, Germany
Clinics, France
Clinics, Germany
Clinics, Spain
Countries in which this study is being conducted
International study

France
Germany
Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/07/201322/07/2013
Start date of data collection15/06/201422/07/2014
Start date of data analysis01/11/201427/11/2014
Date of interim report, if expected
Date of final study report08/05/201521/05/2015
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAlcon Labs, Inc.100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Arana
First name Alejandro
Address line 1Trav. Gracia, 56, Atico 1
Address line 2 
Address line 3 
CityBarcelona 
Postcode08006 
CountrySpain
Phone number (incl. country code)34933622805 
Alternative phone number 
Fax number (incl. country code)34934142610 
Email address aarana@rti.org
Public Enquiries
Title Dr 
Last name Arana 
First name Alejandro 
Address line 1Trav. Gracia, 56, Atico 1 
Address line 2 
Address line 3 
CityBarcelona 
Postcode08006 
CountrySpain 
Phone number (incl. country code)34933622805 
Alternative phone number 
Fax number (incl. country code)34934142610 
Email address aarana@rti.org 
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