The European Contact Lens Forum (ECLF) announces “The CLEER Project”

January 25, 2008 Posted by EUROMCONTACT

 

ECLF, CLEER, ECOO, ECLSO, EFCLNI, EUROMCONTACT, IALE

The European Contact Lens Forum (ECLF) announces the launch of ‘The Contact Lens European Evidence Reporting Project’, or short: ‘The CLEER Project’.
CLEER is a one-year web-based project, coordinated by the ECLF (European Contact Lens Forum, consisting of ECOO, ECLSO, EFCLIN, Euromcontact, and IACLE). The project’s goal is to provide factual data (evidence) about significant incidents in Europe induced by or related to contact lenses (including plano cosmetic lenses). The data gathered by the CLEER project will be used to support discussions with European and national authorities to regulate the supply of contact lenses in order to ensure the protection of the public. Such regulative legislation already exists in the US and the UK.
For the purpose of the CLEER Project, a significant incident is defined as:
‘An asymptomatic or symptomatic clinician-observed slit lamp sign that necessitates temporary discontinuation of lens wear, treatment and/or referral’.
The data can be entered directly by the reporting Eye Care Professional (ECP, ophthalmologist, optometrist or optician) who sees the case and verified the case’s relationship to contact lenses, as well as the case’s significance, or by sending a form (via fax or regular mail) to the secretariat of the national contact lens specialist’s association, who will then enter the data on his/her behalf. The data entered will not allow any identification of the consumer. His / her identity is only known to the ECP entering the data.
The purpose is to capture as best as possible the absolute number of events, by country and for Europe as a whole. The start of the collection process is envisaged for 1 June 2008.
ECLF initiated the CLEER project as it found that there is a lack of European data about significant adverse events concerning contact lenses and the regulatory conditions under which they were purchased. The project aims to define whether the purchase happened under regulated or unregulated conditions.
Regulated means that the lenses were bought with a valid contact lens specification / prescription (issued by a contact lens specialist, either after a fitting or after a follow up visit and not expired) and that was verified by the seller at the time of the purchase. It does not matter where the lenses were purchased, the question relates to the regulatory conditions under which they were purchased.
Unregulated means: Bought without a valid specification / prescription or without a verification of the latter at the point of purchase.
The secure storage and access to the collected data will be tightly controlled, as well as the anonymity of the ECP’s who entered the data.
The analysis of the data will be assigned to a reliable and qualified person, who in turn will also tightly control the access to the data while in his / her possession.
The complete data base will be deleted two years after the end of the project’s data collection period.
It is important to understand that the CLEER project does not replace the post market surveillance / vigilance systems of the manufacturers. CLEER is independent from brand and manufacturer.
The European Contact Lens Forum (ECLF) consists of the following members (in alphabetical order):
- the European Contact Lens Society of Ophthalmology (ECLSO),
- the European Council of Optometry and Optics (ECOO),
- the European Federation of the Contact Lens Industry (EFCLIN),
- the European Federation of National Associations and International Manufacturers of Contact Lens Products (EUROMCONTACT) and
- the European representative of the International Association of Contact Lens Educators (IACLE).

Anne-Marie Wolters , EUROMCONTACT aisbl Secretary General
Helmer Schweizer, EUROMCONTACT aisbl President

Please address any inquires to
Anne-Marie Wolters, (info@Euromcontact.org) or
Helmer Schweizer, (helmer.schweizer@cibavision.com)

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