ECLF stands for: 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).

ECLF goal is to promote the use of  contact lenses. In order to do this, ECLF works on
projects which can best be addressed by a joint, combined effort of all players in the
contact lens field.

CLEER is a web-based project running from June 1st2008 until December 31, 2009
with the goal 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 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. You can report all incidents from June 1st, 2008 until
December 31, 2009, even retroactively.

Several published reports about eye health problems caused by the unregulated sale
of contact lenses in the US have triggered the US and the UK government to regulate
the sale and not only the fitting of contact lenses. When speaking to the European
Commission and national health authorities about extending the UK type law to all of
Europe, they asked for European, not US data, but there is no report or study at hand
for Europe on this matter. The CLEER-project aims to provide the data that will enable
a factual discussion about the benefits of such a regulation.

The data collection process is handled by an experienced company, who keeps the
data in safe storage and tightly controls access of the data. All state-of-the-art security
measures will be applied to prevent intrusion into the database via the internet or else
wise. No personal patient information will be collected. The identity of recording of the
Eye Care Professional’s (details by registration) and the report details are split in two
databases. The contracted analyst will only receive the report details and no information
about the reporting ECP, except the country for which the report applies.

Any access to or work on the data needs approval from ECLF board. Such requests
can be made by the ECP (deletion or modification), by the analyst or the data gathering
company itself. Any such request will be handled in a way that does not disclose the ECP’s
identity.

In case of the need for a clarification about a data entry, the data collecting company may
be authorized by ECLF to ask the ECP for this clarification and make any appropriate
corrections to the database thereafter. Neither ECLF nor the analyst will be allowed know
a reporting ECP, unless the latter clearly agrees to be contacted by the analyst directly
or reveals his identity himself. All access to the data will be carefully documented by the
data gathering company.

This is mainly a question of the local laws. The CLEER-project asks you to receive the
patient’s consent, that some details about the incident that she/he experienced will be
entered in a data base of a European wide research project. This entry does not include
any reference to the patient and her/his identity. All collected data will be destroyed by
June 2011. Access and use of the data is tightly controlled and data protection rules
are observed.

Patient consent means, that she/he agrees that some details about the incident that
she/he experienced will be entered in a data base of a European wide research
project. (see also: What should I tell my patient)

The data will be analysed by a very knowledgeable and experienced member of the
IACLE offices in Sydney, NSW, Australia.

In order to keep the number of records manageable and the report meaningful, the
CLEER-project only collects significant incidents. A significant incident is defined as:

An asymptomatic or symptomatic clinician-observed slit lamp sign that necessitates
one or more of the following:

• temporary discontinuation of lens wear
• treatment
• referral

In the report you can specify the observed slit lamp signs for this incident.

You can report in two ways. The first and easiest is to do it on the internet yourself.

Before you are able to enter a report, you do, however register once and await the return e-mail giving you access to the report form. You can register here.... - To visit the reporting page, click here....

The second possibility is to report via your professional national association by using a paper copy of the report form and fax or mail it to the Association’s secretariat. They will then place the report on the web for you.

The form can be obtained from these secretariats or be downloaded in pdf format from the CLEER-project web page.

This is done to keep the number of records manageable and the report itself meaningful when discussing the protection of the public, more explicitly: the health of contact lens wearer’s eyes.

It may be helpful to have a look at the Guidance of the College of Optometrist about the system that already exists in the UK. A sale that was done in compliance with the requirements laid out in this guidance would clearly be defined as a regulated one. Any non-compliance with the guideline
would qualify the sale in question as a non-regulated one. 

In short:

• Regulated means: 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 is not expired). The validity of the contact lens specification / prescription was verified by the seller at the time of the purchase. It does not matter where bought, the question is about 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 CLEER-project uses the word specification to describe a paper, issued by the contact lens specialist after the fitting process and which contains:

* Name of fitter, address details of practice / shop
* Name, address and birthday of wearer
* Date of issue
* all lens parameters needed to make, order the exact same lenses as fitted, dispensed
* lens manufacturer, brand, replacement frequency
material, base curve, diameter, power (sphere, cylinder, axes, add power, …
* other important lens details not covered yet
* recommended wearing & replacement schedule
* recommended lens care product(s)
* Date until which the specification is valid, usually one year.

In English literature, these information are covered in a paper that is named a prescription. In other languages, the English word prescription may however be interpreted as a paper that can only be issued by a medical doctor. Using the word specification and not prescription, does not mean that any one else but those allowed to fit contact lenses by national laws may issue one. These laws are still to be obeyed.

In the easiest case, the one where the seller of the contact lenses is also the issuer of the specification, this can be done by checking the patient record card, file. There one would check that the information in the presented specification is correct and that it is still valid, not expired.

In case the seller is not the issuer, the seller has to contact the issuer via fax, phone or e-mail, provide the information in the specification (fax, send a scan or read out) and ask him to confirm that the information is correct (matches the patient record card of the issuer, including expiration date). If all information matches the record, the specification is called verified and valid by the issuer.
See also: the Guidance of the College of Optometrist about the system that already exists in the UK.

The registration step ensures that the ability to place a report is only given to eligible Eye Care Practitioners. Entering the Practitioner’s National Professional Association allows for verification of this eligibility via this Association’s member register, before granting access to enter reports.  

This step is done, to ensure that only eligible Eye Care Practitioners can enter data, which then ensures that the entered data meets the definition of significance and that thus serves the project’s goal.

The data can be entered directly by 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.

You can go onto the internet and look at the Guidance of the College of Optometrist about the system that already exists in the UK.

You can also look at

UK

The Opticians Act 1989: http://www.opsi.gov.uk/acts/acts1989/ukpga_19890044_en_1
The Opticians Act (Amendment) Order 2005: http://www.opsi.gov.uk/si/si2005/20050848.htm

US
http://www.ftc.gov/opa/2004/10/BUS62-contact.pdf
http://www.ftc.gov/opa/2004/10/BUS63-contactfaq.pdf