Dry-Eye Diagnosis: 21st-Century Tools
Kent C. Review of Ophthalmology (2013).
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 being 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 the environment.
5. Eject the membrane in a storage container by pushing hard onto the push-button. The 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. The EYEPRIM™ sampling membrane is compatible with most staining techniques. Note: the membrane cannot be made transparent, but powerful transmitted light can go through it. You can also use reflected light microscopy.
Flow cytometry
Cells collected with EYEPRIM™ can be analysed by flow cytometry once they have been detached from the membrane. A single EYEPRIM™ membrane is sufficient for such a 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 to the choice of extraction buffer depending on the analysis to be performed. DIGE buffer is particularly suitable for 2D-PAGE proteomic mapping. A 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 cell secretions. This technique is performed on EYEPRIM™ conjunctival impression samples, using a laser scanning microscope.
Download EYEPRIM Handbook (PDF)
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)
- Minimized sample contamination
Device advantages
- Easy handling
- Faster procedure
- No anaesthesia needed
- Perfect fit with the patient’s eye
- Sterile device
- Easy sample recovery
Sampling performances
- 2 times more cells collected with a 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.” Clinical study, undisclosed source (data from 126 membranes).
“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.” Françoise 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 advice 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, which shall be 2 cm minimum to allow proper ejection of the membrane. Should you need a product reference for a container, OPIA Technologies can provide you advice on this subject. Contact us at sales@opiatech.com.
What kind of reagent can I use to conserve the sample if I can’t do the analysis immediately?
The proper reagent depends on the kind of analysis you are planning to perform on the sample. For RNA conservation, an RNase-free stabilization reagent shall be used. For DNA conservation, you should choose a DNase-free stabilization reagent. Cell integrity is not a criterion for those kinds of analyses. For flow cytometry and cytology methods however, the main criterion is the preservation of cell integrity. PFA-like reagents or methanol/water-based solutions shall be used for such analyses. OPIA Technologies can provide you advice on this subject. Contact us at sales@opiatech.com.
How long can I preserve the sample before analysing it?
Preservation depends on the kind of reagent used and the temperature conditions. Some reagents can preserve the sample at ambient temperature for up to one week. OPIA Technologies can provide you advice 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 laboratories in Europe and the US that can perform them 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? Is topical anaesthesia required?
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 (CCAM code: BCHP001).
How can I place an order?
Write to us directly at sales@opiatech.com.
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, Cimbolini N, Feraille L, Kechad M, Elena PP. ARVO meeting 2011, Fort Lauderdale, FL, USA. ARVO e-abstract No. 1937, poster D918.
OPIA Technologies, Paris, France · Iris Pharma, Nice, France
Assessment of a New Device for Conjunctival Impression
Roy P, Cimbolini N, Antonelli S, Feraille L, Elena PP, Baudouin C. ARVO meeting 2012, Fort Lauderdale, FL, USA. ARVO e-abstract No. 1868, poster A331.
OPIA Technologies, Paris, France · Iris Pharma, Nice, France · Ophthalmology, Quinze-Vingts Hospital, Paris, France
Assessment of the Eyeprim Device for Conjunctival Impression and PCR
Roy P, Groux H, Cottrez F, Protat L. Invest Ophthalmol Vis Sci 2013;54: E-Abstract 5444.
OPIA Technologies, Paris, France · Immunosearch, Grasse, France
Assessment of the EyePRIM Device for Conjunctival Impression for Flow Cytometry
Tomlins P, Roy P, Curnow J, Rauz S. Invest Ophthalmol Vis Sci 2013;54: E-Abstract 5430.
Centre for Translational Inflammation Research, University of Birmingham, United Kingdom · OPIA Technologies, Paris, France
Optimization of a protein extraction method compatible with proteomic approaches using a new device for conjunctival impression
Roy P, Soria J, Etxebarria J, Suarez-Cortes TM. Invest Ophthalmol Vis Sci 2014;55: E-Abstract 2763.
OPIA Technologies, Paris, France · Bioftalmik Applied Research, Derio, Spain · 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.
Contact
Your delivery country is not in Europe ?
Please contact us directly by email to check availability of Eyeprim in your country
Customer service :
OPIA Technologies S.A.S.
17 rue Moreau 75012 Paris, France
Legal notice
Web site: www.eyeprim.com
Web site owner and editor: OPIA Technologies S.A.S.
17 rue Moreau 75012 Paris, France
Tel. 01 43 44 86 41
Intra-community VAT number: FR815190024228
S.A.S. with a capital of 43,100 euros
Registered at the chamber of commerce of Paris 519 024 228 00016
Code NAF: 7211Z
Publication director: Mr. Pierre ROY
Copyright EYEPRIM picture: O. Roydor
Customer service: OPIA Technologies S.A.S., 17 rue Moreau 75012 Paris, France. Tel. 01 43 44 86 41
Hosting by o2switch, Chemin des Pardiaux, 63000 Clermont-Ferrand, France.
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Terms of Use and Privacy Policy
Scope
These terms and conditions must be delivered or sent to any customer for ordering, which implies full and unrestricted agreement with these conditions, to the exclusion of all other documents issued by the seller, those having indicative value. Present order is therefore firm and final.
Payment
The payment is made under the conditions provided in the order. Any purchase is normally payable in cash and without discount at time of order.
Delivery information
OPIA Technologies holds in stock the products described on the website www.eyeprim.com.
If, despite the care taken by OPIA Technologies inventory management for products offered through the site, a product was out of stock, the buyer will be notified by email of a delay of shipment or a refund offer.
According to your country, the shipping costs are fixed and included in all our offers. Shipping costs appear on the order and on the invoice.
All packages are sent by registered post (Colissimo La Poste) so please allow 3-5 working days for delivery (orders placed on a weekend or bank holiday will not be processed until the next working day).
If you have not received your order within 7 working days please ring our customer service number, +33 1 43 44 86 41, or email sales@opiatech.com.
If you are ordering from outside the European Union and USA, please call our customer service number +33 1 43 44 86 41 for exact pricing.
Returns & Refunds Policy
Our returns policy does not affect your legal rights under the distance selling regulations or other legislation.
For a refund or exchange of any product that you are not happy about after you have received your goods, you can return any OPIA Technologies products to us for a full refund. The goods must be accompanied by the delivery note. The items must be unused and returned in the original packaging within 2 weeks of receipt.
We cannot accept back any used products.
Our customer services team can be contacted on +33 1 43 44 86 41 or by email at sales@opiatech.com to assist you.
Please allow at least 2 weeks to process your refund once we have received your returned goods. The refund will be credited to the account that was used to pay for the original purchase.
If you have given an e-mail address we will send you an e-mail confirming that we have refunded your account.
Please note that OPIA Technologies will only refund the delivery charge in the instance of incorrect, damaged or faulty goods. This does not affect your statutory legal rights.
Dispute Resolution
If for any reason you have an issue that cannot be resolved by the OPIA Technologies customer services team, you will need to put your dispute into writing. This needs to be sent to the Commercial Director, OPIA Technologies, 17 rue Moreau, 75012 Paris, France.
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