EYEPRIM™
The first medical device to perform reliable conjunctival
impressions of the living eye by OPIA Technologies

EYEPRIM™ is a sampling medical device for the collection of conjunctival cells from the ocular surface of the eye, for the purpose of analysis.

EYEPRIM™ is the first validated and reliable tool addressing the sampling method traditionally called impression cytology, or conjunctival impression.

From an original idea of professor Baudouin (M.D., professor and chair of ophthalmology, Quinze-Vingts Hospital), EYEPRIM™ solves all the issues related to this sampling technique and provides great sampling performances, in a reliable, reproducible, and user-independent manner.

Very easy to use, EYEPRIM™ is provided sterile and does not need local anaesthesia.

EYEPRIM™ is certified CE.

Consult instructions for use. EYEPRIM™ is a Class I (sterile) medical device according to the directive 93/42/CEE, CE 0499 (SNCH)

1. Patient preparation: The patient must look up or down according to the selected sampling area.
No Anaesthesia required.

2. Position the device upon the conjunctiva. The inner radius can be positioned relative to the limbus.(*) The membrane is stretched onto its support before to be applied on the eyeball.(**)

3. Press gently on the push-button until reaching the stop. Hold from 2 to 3 seconds.

4. Release the pressure before removing the device from the eye, in order to protect the sample from environment.

5. Eject the membrane in a storage container by pushing hard onto the push-button.
(Inner diameter of the storage container should be at least 2 cm.)

Download Instruction for use (PDF)

Consult instructions for use. EYEPRIM™ is a Class I (sterile) medical device according to the directive 93/42/CEE, CE 0499 (SNCH)

EYEPRIM™ is used by any organization – Contract Research Organizations, academic or private research centres, pharmaceutical companies – interested in improving the bio-molecular analysis of the ocular surface with a reliable sampling tool.

EYEPRIM™ is also used in routine clinical practice by ophthalmologists to sample the conjunctiva of patients in order to refine the diagnosis of their ocular surface with further analysis.

Consult instructions for use. EYEPRIM™ is a Class I (sterile) medical device according to the directive 93/42/CEE, CE 0499 (SNCH)

Cytology

Classical Cytology analysis is possible with a suitable microscope after proper staining of the membrane. EYEPRIM sampling membrane is compatible with most staining techniques.

Note: the membrane cannot be made transparent.

Optical cell counting (x20) upon a EYEPRIM sampling membrane.

Flow cytometry

Cells collected with EYEPRIM™ can be analysed by flow cytometry once the cells have been detached from the membrane. A single EYEPRIM™ membrane is sufficient for such measurement.

Measurement of HLA-DR by flow cytometry on conjunctival cells sampled with EYEPRIM™.

Quantitative RT-PCR

EYEPRIM™ has especially great yield performances for ribonucleic acids (RNA) and allows the measurement of several biomarkers from a single membrane.

Download EYEPRIM Handbook (PDF)

Consult instructions for use. EYEPRIM™ is a Class I (sterile) medical device according to the directive 93/42/CEE, CE 0499 (SNCH)

EYEPRIM™ allows very fast, virtually painless, and minimally invasive cell collection from the living eye.

Technical performances

Precise location of the sampling zone
Immobilization of the eye
Isolation from tear film and eyelid margin
Repetitive sampling parameters (pressure, sampling surface)
Minimize sample contamination

Device advantages

  • Easy handling
  • Faster procedure
  • No anaesthesia needed
  • Perfect fitting with the patient eye
  • Sterile device
  • Easy sample recovery

 Sampling performances

  • 2 times more cells collected with 40% reduction in sampling time compared to classical conjunctival impression
  • Reliable and reproducible sampling
  • Optimized sampling for bioassay analysis.

Up to 10 genes measurable by PCR with a single sample.” Steve Pflugfelder, MD.

300 ng of purified RNA on average from a single membrane.” Immunosearch.

EYEPRIM™ collects between 500 ng and 3000 ng of purified RNA per membrane”. (Data from 126 membranes.) Clinical study, undisclosed source.

Enough cells in a single sample for the measurement of at least one biomarker (flow cytometry). Very encouraging! One membrane is sufficient instead of 3 sometimes with the classic sampling method.” Francoise Brignole-Baudouin.

Regulatory status

  • CE marked
  • FDA registered (US)

Download Brochures

Consult instructions for use. EYEPRIM™ is a Class I (sterile) medical device according to the directive 93/42/CEE, CE 0499 (SNCH)

Is there any container supplied with EYEPRIM™ for sample recovery?

There is no container supplied with EYEPRIM™ for the time being. The main criterion is the inner diameter that shall be 2 cm minimum to allow proper ejection of the membrane. Shall you need some product reference for a container, OPIA Technologies can provide you advices on this subject. Contact us at: contact@opiatech.com

What kind of reagent can I use in order to conserve the sample if I can't do the analysis immediately?

The proper reagent depends on the kind of analysis that you are planning to perform on the sample. For RNA conservation, a RNase-free stabilization reagent shall be used. For DNA conservation, you should choose a DNase-free stabilization reagent. The cells integrity is not a criterion for those kinds of analyses. For flow cytometry and cytology methods however, the main criterion is the preservation of the cells integrity. PFA like reagents or methanol / water based solution shall be used for such analysis. OPIA Technologies can provide you advices on this subject. Contact us at: contact@opiatech.com.

How long can I preserve the sample before to analyse it?

Preservation depends on the kind of reagent used and the temperature conditions. Some reagent can preserve the sample at ambient temperature up to one week. OPIA Technologies can provide you advices on this subject. Contact us at: contact@opiatech.com.

Where can I analyse my sample?

If you do not have the resources or equipment required to perform the analyses, we can put you in touch with some laboratories in Europe and US that can perform it for you. Contact us at: contact@opiatech.com.

How do I deliver the samples to analytical centres?

There are laws about the transport of biological samples. OPIA Technologies can provide you advices on this subject. Contact us at: contact@opiatech.com.

What kind of membrane is inserted in the EYEPRIM™?

The membrane is made of polysulfone. It is optimized for bioassay.

Can the membrane be made transparent?

The membrane cannot be made transparent.

Can I do cytology analysis with the EYEPRIM™?

Classical Cytology analysis is possible with a suitable microscope after proper staining of the membrane. The membrane cannot be made transparent.

Are there other sampling shapes available?

For the time being, only one sampling shape is available. EYEPRIM™ was designed to match all patient ocular surfaces from 3 years old.

Are there other kinds of membrane available?

For the time being, only one sampling material is available. The membrane is made of polysulfone. It is optimized for bioassay.

Does the procedure hurt?

The collection of cells with EYEPRIM™ is quasi painless and can be performed without local anaesthesia.

Is topical anaesthesia required before sampling?

The collection of cells with EYEPRIM™ is quasi painless and can be performed without local anaesthesia.

Is the procedure reimbursed?

In France, a diagnostic impression on the conjunctiva is a refundable act at the price of 19,20 euros. CODE CCAM: BCHP001.

How can I place an order?

You can purchase EYEPRIM™ on this website using the Order Online procedure below. You can also contact us directly at: sales@opiatech.com.

Can I be supplied with product samples?

OPIA Technologies can provide samples. Contact us at: contact@opiatech.com

Order online

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For veterinarian application, contact Iris Pharma at l.elena@iris-pharma.com

 

About US

logo

Founded in January 2010 and based at the Vision Institute in Paris, OPIA Technologies is a company dedicated to the development of an innovative portfolio of medical devices for the ocular surface.

Our aim is to provide innovative and reliable sampling tools in order to further introduce the bio-molecular analysis of the ocular surface and to improve the care of patients with ocular surface diseases.

The first product developed by OPIA is EYEPRIM™, a device to perform conjunctival impressions of the living eye, enabling further analysis of cells and biomarkers to help diagnose several ocular surface disorders such as dry eye, allergies or infections.

Opia meets the highest level of regulatory requirements with a quality assurance system certified ISO 13485.

Download Certificate ISO 13485 OPIA

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Customer service : 
 OPIA Technologies S.A.S.

17 rue Moreau 75012 Paris, France

Tel. +33 (0)1 53 46 26 23