I-PEN® TEAR FILM OSMOLARITY SYSTEM

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Manufacturer: I-MED PHARMA
Product code: DEIPEN

Osmolarity testing is the most objective way of diagnosing and measuring Dry Eye Disease, and the single best marker of disease severity, according to TFOS-DEWS studies. I-PEN® is the only diagnostic testing device to detect and measure the elevated tear film osmolarity levels associated with marginal, mild, moderate, and severe Dry Eye Disease.

The I-PEN® Osmolarity System, used in conjunction with the I-PEN® Osmolarity Single-Use-Sensors (SUS), provides a quick and simple method for determining tear osmolarity from the tear soaked papabral conjunctiva. After approximately 2 seconds of contact with the eyelid tissue, the I-PEN® will display a quantitative tear osmolarity test result in units of mOsms/L. No calculations required. 

 

The I-PEN® is designed for use as an in-practice screening device both for patients presenting with dry eye symptoms and for all pre- and post-surgical patients. In addition, the I-PEN® is an invaluable asset for monitoring the progress of dry eye treatment therapies. The I-PEN® is for professional in-vivo diagnostic use only. 

Quantitative measurement of osmolarity
Simple to use and no calculations required
Accurate and reliable results
Quick to administer - 2 seconds per eye
Minimally Invasive
Affordable

Why is osmolarity so important?

Osmolarity is important because it provides an objective number, which can then be monitored and measured against. It provides you with a means to classify the severity of a patient’s DED.

 

The I-PEN® produces a specific number that represents the patient’s osmolarity result and the band it falls in (i.e.. 310-330) gives it context.

A high osmolarity reading indicates an increasing severity of evaporative dry eye (EDDE).

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How to use the I-PEN® 

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Remove Single Use Sensor (SUS) from the package

Remove the unit cover and insert the SUS without touching the gold nodes or sterile tip

Ask the patient to gently squeeze their eyelids shut for 30-60 seconds prior to taking a reading

Position the tip of the sensor just above the lower eyelid with the LCD screen facing up

When the patient is ready switch on the device with the SUS inserted

From a 30-45˚ angle from horizontal, gently lower the end of the sensor on to the conjunctiva on the inside of the lower eyelid

When correctly placed, the tip of the sensor should be depressing the surface slightly so that both gold nodes are in good contact with the conjunctiva

The I-PEN® will make an audible beep after several seconds and display the reading on the screen

Eject and discard the Single Use Sensor

I-PEN® test results are displayed on the LCD in units of mOsms/L. No calculations are required. The chart below shows some typical test results and their possible interpretations.

 

275

290

305

< 290

Normal

290-310

Marginal

330-350

Moderate

> 350

Severe

320

335

350

365

310-330

Mild

380

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How will the I-PEN® change my scope of practice?

Approximately 50% of patients who enter a clinic have Dry Eye Disease. Many of these however, will go undiagnosed.

 

 

I-MED Pharma recommend that every eye care professional conducts a validated questionnaire such as the OSDI or DEQ-5 and any patient whose result comes back positive for symptoms, should be screened with the I-PEN®.

The I-PEN® gives an objective measure of the severity of the DED and helps determine the correct treatment pathway to pursue. It allows for patients to clearly understand their treatment strategy, as you can point out their osmolarity result on the dry eye severity scale. The I-PEN® is also a great tool to help monitor the progress of the  treatment and adjust accordingly. For example, patients can be retested after 3 months of treatment to see if their osmolarity result has improved.