FAQ

The C-Eye Device

How much does the device cost?
  • The price for the device and related product line will be determined by your local distributor. Please contact your local distributor directly when the product line becomes available. In the future, you will be able to find your country’s distributor on our website. To get notified of changes, you can subscribe to our newsletter via our website.
Where and when can I buy the device?
  • Currently, EMAGine is awaiting the CE mark approval for the device and protection cap. Once approved, then the C-Eye device and related product line will be launched in the MENA regions. The CE-mark approval is expected by Q2 2017. You would then be able to purchase your device directly from your local distributor in the MENA regions.
When will the device and related product line be commercially available?
  • Estimated Q2 2017, pending CE mark approval.
Does the device and related product line have a CE-mark?
  • The EMAGine product line will have a CE-mark before sales commence.
  • C-Eye device and cap, estimated Q2 2017.
When will the device and related product be ready for “my” country?
  • EMAGine has chosen the Middle East for the market introduction of the C-Eye device due to the high incidence rate of KC and strong relationship with an regional distributor.
  • If you live in one of the countries served by Medicals International, then you may receive the device in Q2 2017, pending the CE mark approval.
  • We take pre-orders for all other countries. Please contact us directly via sales@emagine-eye.com.
Why does the model not have a high-definition camera as stated last year?
  • The company strategy is to launch a product proven to be safe and effective for the proposed treatment modalities.
  • Since treating at the slit lamp is a new approach, EMAGine wanted to first simplify the method to ensure quality, and then introduce new features once the device has been successfully used /demonstrated clinically.
Why should I switch from my existing lamp?
  • CXL at the slit lamp saves you time and money, and it increases the likelihood of a better clinical outcome due to the unique. fluorescence mechanism (measures the riboflavin saturation to confirm that there is enough riboflavin to be effective).
  • Time: clinician does not have to transfer the patient to an OR for the treatment.
  • Money: blocking an OR for this treatment is no longer required.
Which are the slit lamps the C-Eye device will be compatibe with?
  • Initially, the C-Eye device will be compatible to Haag Streit and Haag Streit type slit lamps and to Carl Zeiss and Carl Zeiss type slit lamps.
  • Adapters for other models will follow.
If I do not have a Haag-Streit or Carl Zeiss (-type) slit lamp, can I still use the C-Eye device?
  • Yes: using the optional Table Stand Mount, you can attach the device to a table.
  • EMAGine plans to other adaptors for cover the whole spectrum of models.
What is the battery life of the device?
  • One full charge will allow for at least 5 consecutive treatments.
  • The battery life will last at least 500 charging cycles. This is the typical lifespan of a lithium-ion battery. If needed, the battery can be replaced by EMAGine.
What makes the device different from the other CXL devices?
  • KC/ectasia treatment
    • Ability to treat at the slit lamp (saves time/money).
    • Ability to measure the riboflavin saturation (improves clinical outcome).
  • Corneal Infections
    • Ability to treat at slit lamp (avoids contamination of OR).
    • Slit Lamp is available in every ophthalmologist’s office. The patient will not need to be referred to a larger center but can immediately receive treatment with the primary ophthalmologist.
What is contained in the kit?
  • Currently, the kit comprises the sterile single-use cap and a speculum.
  • The inclusion of a single-vial of riboflavin is currently pending due to EU’s July 2014 recommendation of changing riboflavin’s classification from a medical device (CE) to a pharmaceutical drug.

CXL for Keratoconus / Ectasia

If a patient is treated at the slit lamp, does the riboflavin dissipate due to gravity?
  • There is no need to reapply the drops.
  • In a scientific study, riboflavin was applied in the horizontal position on the cornea, and then the cornea was suspended vertically for up to 60 minutes. The riboflavin distribution remained virtually the same, with a difference of only 3% between upper and lower cornea after 1 hour. The study is currently under peer-review.
How do I focus the beam?
  • Focusing is easy: you use the optics of the slit lamp and focus on the epithelium of the central cornea
  • Good to know: even when in a defocus of ± 5mm, the increase (when slit lamp too close) and decrease (when slit lamp too far) in intensity is less than 5%. In other words, when the ophthalmologist focuses the image on the iris plane or on the lids plane, the intensity still is fine.
Are there recommended accelerated treatment protocols for KC treatment?
  • Accelerated 9 mW/cm2 for 10 minutes à solid body of evidence that this setting stops keratoconus progression
  • Accelerated 18 mW/cm2 for 5 minutes à mixed results so far. Probably better suited for early keratoconus
  • Accelerated 30 mW/cm2 for 3 minutes has no substantial clinical data published so far. Do not use for KC.
Is CXL for the treatment of keratoconus covered by health insurance?
  • Most countries do not reimburseme for CXL treatment, however, please check your national legislation.
  • EMAGine’s website will provide updated information about health care coverage soon.
In non-compliant patients, what treatment modality should be performed?
  • A non-compliant patient that does not allow for irradiation at the slit lamp will probably need irradiation in the lying position.
  • The C-Eye device will also have the option to be mounted on a table mount stand, similar to other current CXL devices (i.e. IROC UV-X device).
Why does the C-Eye device does not provide a pulsed light like other models on the market?
  • Because pulsed light does not provide any advantage. We have proven this in a large laboratory study (submitted), and have confirmed it in a clinical study (published). The reason is that the oxygen diffusion still is too slow to bring any clinical advantage to pulsed treatments.
  • In other words, pulsed light is an expensive gadget.
What is the difference between fluence and intensity?
  • Intensity = mW/cm2
  • Fluence (J/cm2) = Intensity x time (seconds)
  • 4 J/cm2 = 3 mW/cm2 x 1800 seconds = 9 mW/cm2 x 600 seconds, etc.

PACK-CXL for Corneal Infection

What does PACK-CXL stand for?
  • PACK means “Photoactivated chromophore for infectious keratitis”-CXL and was suggested and adopted as a term at the 2013 CXL congress.
  • See: Hafezi F, Randleman JB. PACK-CXL: defining CXL for infectious keratitis. J Refract Surg. 2014. 30(7): 438-9. 10.3928/1081597X-20140609-01.
What scientific evidence is there to prove that PACK-CXL works?
  • The pilot study has been performed in 2006/2007 in Zurich, Switzerland and was published in 2008.
  • Currently, there are more than 60 scientific publications on the topic on MedLine, including several Phase II studies. A large prospective randomized multicenter trial is on the way, comparing PACK-CXL and antimicrobial care.
What authorization exists to perform PACK-CXL for treatment of infectious keratitis?
  • PACK-CXL is currently performed as an off-label use. “off-label” means that a known technique which is valid for a certain indication is used for a different, not yet validated indication.
  • This is similar to the use of Avastin vs Lucentis in AMD.
Does health insurance reimburse for PACK-CXL for the treatment of infectious keratitis?
  • Not (yet).
How much should a patient be charged for a PACK-CXL treatment?
  • PACK-CXL is still an experimental treatment. Therefore, there is no recommended charge for such a treatment.
Does the epithelium need to be removed to perform PACK-CXL?
  • Because the infiltrate/ulcer breaks down the epithelium over the infection, all that needs to be done is to remove debris with a dry sponge, if necessary.
What is the recommended treatment modality for corneal infection treatment at the slit lamp?
  • 1)   Apply topical anesthetics
  • 2)   PACK-CXL: remove debris at slit lamp with dry sponge
  • 2)   CXL: perform abrasio at Slit Lamp (yes, you can!)
  • 3)   Take patient to reclining Chair, instill riboflavin (20′)
  • 4)   Mount C-Eye Device and Sterile Cap
  • 5)   Irradiate at the Slit Lamp
What forms of pathogens does PACK-CXL effectively kill?
  • Bacteria, including aureus, both MSSA and MRSA (antibiotic-sensitive and antibiotic-resistant), Pseudomonas aeruginosa, and Staphylococcus epidermidis. Efficacy 95 to 99%.
  • Fungi, including Fusarium and Candida albicans. Efficacy 60-70%.
Does PACK-CXL kill acanthamoeba and/or herpes simplex?
  • Not (yet), there are mixed results.
  • Solar disinfection (SODIS) is a similar technique to PACK-CXL. In SODIS, water is disinfected using sunlight (energy) and riboflavin. SODIS can kill Herpes simplex virus and acanthamoeba, but the overall total energy is much higher than what we currently use in the cornea.
Although the recommendation is to use PACK-CXL as early as possible, is it still effective for deep(er) ulcers?
  • It certainly helps to kill additional microorganisms. More clinical studies are needed to answer this clinical question.
Can we use “accelerated” settings in PACK-CXL?
  • We have tested and published in the laboratory that the efficacy of bacterial killing remains the same when the treatment is accelerated even to 30 mW/m2 for 3 minutes.
  • Our ongoing multicenter trial is using accelerated protocols between 10 minutes and 5 minutes.
What is the upper limit of intensity that should be used in PACK-CXL?
  • We recommend not to exceed 18 mW/cm2 for 5 minutes per now.
Are there any limitations to the patient demographics / patient profiling for PACK-CXL treatment?
  • No limitations are known.
What is the recommended current postoperative treatment for a PACK-CXL?
  • Daily consultations, continue with standard antimicrobial treatment, take care of the open surface.
Can PACK-CXL be repeated?
  • There currently is too little data to give a clear answer. However, the PACK-CXL energy settings are the same as in classic CXL for keratoconus, and here, we know that a repeated treatment is possible without harming the eye.
Is PACK-CXL superior to classic antimicrobial treatment?
  • PACK-CXL is an addition to classic antibiotic treatment. It should be used as early as possible, and it should help to accelerate the time to healing.
Will PACK-CXL some day replace the antimicrobial treatment?
  • It is too early to speculate about this.
What if I treat a very thin cornea with infection?
  • We currently recommend to use PACK-CXL rather in early infection. In early infection, the cornea usually still is thick enough for CXL, even at the area of infection.
  • In case an advanced ulcer is treated, the aim, also in classic treatment, usually is to “calm” the surface and end up in a quiescent scar. If PACK-CXL is used in these cases, the irradiation might indeed harm part of the endothelium over the thinnest part of the eye. A risk/benefit analysis must be made by the doctor: even when using antibiotics only, a quiet scar would the the best outcome possible. Under these circumstances, the doctor has to decide whether he/she wants to use PACK-CXL to further increase chances of calming the situation.

Riboflavin

How does the fluorescence mechanism work?
  • The C-Eye device will constantly measure the amount of fluorescence that is emitted by the excited riboflavin. The amount of fluorescence directly correlates with the saturation of the riboflavin concentration in the cornea.
  • If insufficient fluorescence = insufficient levels of riboflavin are detected, the device will stop the treatment until riboflavin levels allow for safe and efficient CXL. This is possible under 2 scenarios:
    • at the beginning of irradiation, treatment stop might be due either to an insufficient concentration of rinoflavin in the corneal stroma, or to the patient’s head moving backwards from the chin rest, increasing the distance to the fluorescence detector. Reposition the patient and check whether irradiation re-starts. If it doesn’t, then re-apply riboflavin.
    • During irradiation: since the concentration of riboflavin within the stroma will not change in the span of 5 or 10 minutes, the most likely reason for the device to stop irradiation is a backward movement of the patient’s head.
Can hypotonic (hypo-osmolaric) riboflavin be used for both indications (keratoconus and corneal infection)?
  • Yes, you may use the same solution for both indications.
Do I apply the riboflavin over the ulcer only, or the entire cornea? Do I irradiate only the ulcer or the entire cornea?
  • The entire cornea should be instilled with riboflavin and irradiated, this for 2 reasons: 1) the riboflavin has two properties, it induces the killing effect, but it also acts like a shield from the UV light, by absorbing it. The riboflavin in the periphery of the healthy cornea is protectiong the corneal endothelium from too much UV irradiation, 2) the ulcer is bigger than the visible portion of it (compare it to the top of an iceberg). By irradiating the entire cornea, we ensure that the “invisible” parts of the ulcer are treated, too.