KeraKlear Instructions For Use
KeraKlear Non-Penetrating Artificial Cornea
The KeraKlear Artificial Cornea is a medical device for the treatment of cornea blindness. The KeraKlear is designed to be implanted into a partial thickness corneal pocket made by a femtosecond laser through an opening of 3.5 mm in diameter.
The KeraKlear artificial cornea has European CE mark approval. The KeraKlear artificial cornea is not cleared for use in the U.S.A.
The KeraKlear is indicated for patients that have non-inflammatory forms of corneal blindness (e.g. keratoconus, corneal dystrophies, corneal scars, and corneal edema). The KeraKlear should not be used in patients with inflammatory causes of corneal blindness such as Steven's Johnson Syndrome, ocular cicatricial pemphigoid or atopic keratoconjunctivitis.
Below is an example of a patient who underwent KeraKlear implantation in Venezuela by Dr. Jose Vargas. This patient has a history of two previous failed corneal transplants due to graft rejection, the last one having been performed 2 years prior to KeraKlear surgery. Pre-operatively, this patient had hand motion vision only.
Figure 1. - Pre-Op
Fig. 1. Shows the pre-operative appearance of the patient's eye. Note the severe opacification and irregularity of the failed cornea graft which is due to corneal edema.
Figure 2. - Post-Op
Fig. 2 shows the post-operative appearance of the patient's eye. Note how the central cornea is clear after the KeraKlear has been implanted. At one month the patient's vision improved to 20/60 without correction and has remained stable through 12 months. This level of visual acuity is sufficient to obtain a driver's license.
Figure 3. - Iris Details Visible through KeraKlear
Fig. 3 shows a high resolution view which shows how the iris details are now visible through the KeraKlear and the patient's failed graft.
Figure 4. - View of OpticNerve through slitlamp
Fig. 4. Shows a slit-lamp photograph of the optic nerve through the KeraKlear, which demonstrates the ability to visualize the fundus and a clear optical pathway.
The success of the KeraKlear for treating multiple corneal transplant failures gives hope that a minimally invasive surgery may become available for this important group of cornea blind patients. This case also demonstrates the feasibility of the KeraKlear to improve the vision in the setting of cornea endothelial dysfunction.
Benefits to the doctors for using the KeraKlear:
1. Procedure done outside of the hospital and in the comfort of a laser suite
2. High success rate: 90% retention after 4.5 years
3. KeraKlear can be stocked in ambient conditions so there is no need to wait for donor tissue.
Benefits to the patients for using the KeraKlear:
1. The KeraKlear is minimally invasive and uses smaller incisions resulting in faster recovery and reduced risk of infection.
2. No risk of immunologic rejection.
3. Significantly faster procedure.
4. Immediate visual improvement. Patients often see better “off the table”.
5. Less wait time to receive the procedure.
The KeraKlear Artificial Cornea has received European CE Mark approval and is used by cornea surgeons around the world. The KeraKlear Artificial Cornea has not yet received U.S. FDA Clearance and is limited in the United States to investigational use only.