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 0051 (IMQ)
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 0051 (IMQ)
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 0051 (IMQ)
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 but powerful transmitted light can go through the membrane. You can also use reflected light microscopy.
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.
Quantitative RT-PCR
EYEPRIM™ has especially great yield performances for ribonucleic acids (RNA) and allows the measurement of several biomarkers from a single membrane.
Protein extraction
EYEPRIM™ provides great protein recovery performances. Particular attention should be paid on the choice of extraction buffer depending on the analysis to be perform. DIGE Buffer is particularly suitable for 2D-PAGE proteomic mapping. Softer buffer should be preferred for protein immunodetection.
3D cytology
3D cytology is a patented analysis method (OcuPharm Diagnostics) for the study of goblet cells and goblet cells secretions. This technique is performed on EYEPRIM™ conjunctival impression sample, using a Laser Scanning Microscope.
Consult instructions for use. EYEPRIM™ is a Class I (sterile) medical device according to the directive 93/42/CEE, CE 0051 (IMQ)
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)
Consult instructions for use. EYEPRIM™ is a Class I (sterile) medical device according to the directive 93/42/CEE, CE 0051 (IMQ)
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: sales@opiatech.com.
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: sales@opiatech.com
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: sales@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: sales@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: sales@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: sales@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.
Can I be supplied with product samples?
OPIA Technologies can provide samples. Contact us at: sales@opiatech.com
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.
Dry-Eye Diagnosis: 21st-Centuary Tools
Kent Christopher. Review of ophthalmology (2013)
Diagnosis of dry eye disease and emerging technologies
Zeev MS, Miller DD, Latkany R. Clinical Ophthalmology 2014:8 581-590
Translating the Emerging Diagnostics for OSD
Cooper MS. Advanced Ocular Care. May/June 2014
Evaluation of Membrane Material for Impression Cytology.
Roy P (a), Cimbolini N (b), Feraille L (b), Kechad M (b) and Elena PP (b).
ARVO meeting 2011; Fort Lauderdale, FL – USA. ARVO e-abstract No. 1937 – Poster D918.
(a) OPIA TECHNOLOGIES, Paris, France – (b) IRIS PHARMA, Nice, France
Assessment of a New Device for Conjunctival Impression.
Roy P (a), Cimbolini N (b), Antonelli S (b), Feraille L (b), Elena PP (b) and Baudouin C (c).
ARVO meeting 2012; Fort Lauderdale, FL – USA. ARVO e-abstract No. 1868 – Poster A331.
(a) OPIA TECHNOLOGIES, Paris, France – (b) IRIS PHARMA, Nice, France – (c) Ophthalmology, Quinze-Vingts Hospital, Paris, France
Assessment of the Eyeprim Device for Conjunctival Impression and PCR.
Roy P (a), Groux H (b), Cottrez F (b) and Protat L (a).
Invest Ophthalmol Vis Sci 2013;54: E-Abstract 5444.
(a) OPIA TECHNOLOGIES, Paris, France
– (b) IMMUNOSEARCH, Grasse, France
Assessment of the EyePRIM Device for Conjunctival Impression for Flow Cytometry
Tomlins P (a), Roy P (b), Curnow J (a) and Rauz S (a)
Invest Ophthalmol Vis Sci 2013;54: E-Abstract 5430.
(a) Centre for Translational Inflammation Research, University of Birmingham, Birmingham, United Kingdom
– (b) OPIA TECHNOLOGIES, Paris, France
Optimization of a protein extraction method compatible with proteomic approaches using new device for conjunctival impression
Roy P (a), Soria J (b), Etxebarria J (c), and Suarez-Cortes TM (b)
Invest Ophthalmol Vis Sci 2014;55: E-Abstract 2763.
(a) OPIA TECHNOLOGIES, Paris, France – (b) BIOFTALMIK Applied Research, Derio, Spain
– (c) Department of Ophthalmology, Cruces Hospital, Baracaldo, Spain
About US
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.
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OPIA Technologies S.A.S.
17 rue Moreau 75012 Paris, France