| |
| |
| KeraKlear Artificial Cornea |
| The KeraKlear Artificial Cornea is a medical device for the treatment of cornea blindness which can be implanted in the eye through an incision that is approximately 1/7th the size of the incision that is required for the most popular commercially available artificial cornea which is known as the Boston Keratoprosthesis (Artificial Cornea). The KeraKlear also has the advantage of not requiring a human donor cornea for implantation, which is necessary for the Boston Artificial Cornea. |
| |
| The KeraKlear has a number of other clinical advantages when compared to the two currently available artificial corneas (Boston Artificial Cornea and Alphacor). These advantages include smaller incisions and faster recovery time for the patient. Instead of the invasive surgery with current products, the KeraKlear procedure will be similar to conventional cataract surgery. |
| |
| The KeraKlear artificial cornea may be implanted in most patients with cornea blindness without penetration into the anterior chamber. This avoids two of the most serious complications of artificial cornea implantation including internal infection of the eye (endophthalmitis) and severe bleeding (expulsive hemorrhage). The use of the KeraKlear artificial cornea also avoids the common complications of corneal transplantation including high astigmatism, corneal graft failure and corneal graft rejection. |
| |
| The KeraKlear artificial cornea has European CE mark approval. The KeraKlear artificial cornea is not cleared for use in the U.S.A. |
| |
| A patient has recently undergone 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 ago. Pre-operatively, this patient had hand motion vision only. 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. |
| Fig 1. Pre-Op |
Fig 2. One Day After KeraKlear Surgery |
| |
|
|
|
| |
|
| On post-operative day one the patient's vision had improved to 20/100 without correction.Fig. 2 shows the appearance of the patient's eye on the first post-operative day. Note how the central cornea is now clear after the KeraKlear has been implanted. At one month the patient's vision improved to 20/60 without correction. This level of visual acuity is sufficient to obtain a driver's license. 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. 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. |
| |
|
| Fig. 3 Iris Details Visible through KeraKlear |
Fig. 4 View of Optic Nerve through Slitlamp |
| |
|
|
|
| |
|
| This clinical case has particular significance for the 20 to 35% of cornea transplant patients who suffer from cornea graft rejection and failure in the United States within 5 years.This group of patients has a 50% or greater chance of failure with repeat grafting. The initial success of the KeraKlear for treating this type of patient gives hope that a minimally invasive surgery with a quick recovery may become available for this important group of cornea blind patients. This case also demonstrates the KeraKlear is able to improve the vision in cases of endothelial dysfunction. |
| |
|
|
| |
| |
|
|
