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This is a type of corneal transplant Lap Joint Keratoplasty Robert C. Arffa, M.D. People who cannot see well because their cornea is cloudy could benefit from a corneal transplant. This is a study of a variation on the standard corneal transplant surgical technique. The new technique is being studied because it has potential advantages over the currently accepted technique. Prior to this study the procedure was performed on a small number of patients, and promising results were obtained. However, since it is a new technique potential results, including the benefits of this technique over the standard technique, and the risk of complications, are not fully known. What is a corneal transplant? The cornea is a clear membrane in front of the colored part of the eye, the iris, and the pupil. It is like the glass front of a camera lens. The light passes through the cornea before being focused by the lens to form an image on the back of the eye, the retina. If the cornea is not clear, or its shape is distorted, the light does not pass through it normally, and a proper image does not reach the back of the eye. One of the most common reasons for the cornea to become cloudy is swelling due to “endothelial cell” failure. The endothelial cells line the back (inner) surface of the cornea. They maintain the normal fluid balance of the cornea by constantly pumping water out of the cornea. Each cornea is endowed with a fixed number of endothelial cells at birth, and these cells do not reproduce. They gradually decrease in number over our lives. Certain ocular conditions can damage or destroy corneal endothelial cells, including trauma, cataract surgery, glaucoma, and infection. If the density of endothelial cells falls below a minimum value, the cornea becomes swollen and cloudy. This can markedly decrease vision and often causes light sensitivity and pain. In such cases the only means of restoring a clear cornea and vision is through transplantation of endothelial cells from a human donor. The traditional technique is called penetrating keratoplasty. The central portion of the patient’s diseased cornea is surgically removed and replaced with a similar portion from a human donor cornea. The common name of this procedure is corneal transplantation. 1 On average, the chance of obtaining a clear cornea after a penetrating transplant is approximately 85%. However, there are some significant problems with our current technique. It takes approximately one year for the wound to heal sufficiently to permit removal of all supporting stitches. In most cases good vision must await prescription of new glasses. Typically new glasses can not be prescribed for at least 6 months, and in some cases not until after all stitches are removed one year after surgery. As mentioned above, good vision is dependent on the corneal surface having a regular curvature. This is difficult to obtain with corneal transplant surgery. On average transplanted corneas have moderate distortion of their surface. Distortion or deviation from a spherical curvature is called astigmatism. In most cases this astigmatism can be corrected with glasses. In some cases good vision can only be obtained with a rigid contact lens, or through surgical reduction of astigmatism. The Lap Joint Keratoplasty Technique Drs. Robert Arffa, Pittsburgh, PA and Massimo Busin, Forli Italy, have devised a variation of the standard corneal transplant technique, which is designed to reduce problems currently observed. Simply put, the new technique involves : 1. creating a donor cornea with an inner (posterior) lip around the circumference 2. creating a matching inner groove on the patient’s cornea 3. sewing the new corneal tissue in place 2 The researchers hope that this technique will result in much more rapid healing than with the current technique. This should permit fitting with new glasses or a contact lens approximately 4 months after surgery (instead of 6 to 15 months with the current technique). Also, they hope that astigmatism or distortion of the corneal surface will be less than with the current technique. The purpose of this study is to determine whether or not this new technique permits faster healing and reduces astigmatism. Prior to beginning this study, 12 patients underwent Lap Joint Keratoplasty surgery. With short-term follow-up of these patients, the results have been very good. Therefore this study will involve additional patients, with closer monitoring of the results. Risks of Lap Joint Keratoplasty Risks of Standard Corneal Transplant Surgery Corneal transplant surgery, as with any surgical procedure entails risk, both to your eye and to the rest of your body. The risks are similar to those of cataract surgery, or any other surgical procedure in which the eye is opened. The risks of endokeratoplasty are almost identical with those of standard corneal transplant surgery. Some of the more common or more serious possible complications follow: There is a small risk from administration of anesthesia. Sedative agents will be administered intravenously, and there is a risk of abnormal reaction. The eye will then be numbed by injection of a local anesthetic. There is a very small risk (<1 in 1000) of sight-threatening complications of this injection. 3 Any time that surgery is performed inside the eye, there is a risk of bleeding or infection developing in the eye. Precautions are taken to prevent this from occurring. Even if such problems develop, in most cases good sight can be maintained with treatment. Increased pressure inside the eye (glaucoma) can occur after surgery. If you have glaucoma before the surgery, the condition can worsen. The pressure usually can be controlled with eye drops or medicine by mouth, but further surgery may be required in extreme cases. The retina is where the image forms in the back of the eye. The retina converts the light to electrical energy, which is transmitted by the optic nerve to the brain. Damage to the retina (swelling or detachment) can occur after any surgery in which the eye is opened. It is often necessary for your skin cells (epithelium) to heal over the new cornea. Usually this occurs within one week of surgery. However, some patients are slow to heal, and patching, use of a bandage soft contact lens, or stitching the lids closed may be necessary. Until the surface cells heal there is an increased risk of infection or ulceration of the cornea Since the new cornea is from another person’s eye, your body may recognize it as foreign. If that occurs, your body may “reject” the new tissue. Approximately half of the time this reaction can be stopped, particularly if treatment is started promptly. However, rejection is the most likely complication of corneal transplantation. If the new cornea is rejected, it will become cloudy and your vision will probably be limited to finger counting. Repeat corneal transplantation can be performed, however, the risk of rejection is increased. Eye donors are screened to eliminate those with diseases that could be transferred to you via the donor cornea. The donor’s general and eye medical history are reviewed, and blood tests are performed for hepatitis and AIDS (HIV infection). AIDS has never been transmitted via a corneal transplant, but we test for it as a precaution. While none of these tests are infallible, there is only a remote chance of transmitting disease via corneal transplantation. It is not possible to list all possible complications of corneal transplant surgery. Other complications can occur that may reduce your sight, or cause you to lose your sight or your eye. Overall there is a less than 1 in 100 chance of losing your sight or your eye. Additional Risks of Lap Joint Keratoplasty The Lap Joint Keratoplasty technique involves making a peripheral “lap joint” between the donor cornea and your cornea. If the two halves are not proper thickness the donor corneal surface could end up slightly above or below the natural surface. This may delay healing. It is possible that irregular healing of the corneal flap after the Lap Joint Keratoplasty procedure could result in a distorted cornea. This would mean that glasses would not correct the vision, and rigid contact lens wear may be necessary. The researchers think that the risk of this is less than the risk with standard transplant surgery, but this is not certain. There is a small risk that the corneal skin cells (epithelium) may grow into the lap joint portion of the wound. Treatment of this condition involves lifting the edge and clearing the 4 cells. Untreated growth of epithelium within the wound may distort vision and may actually damage the wound if severe and progressive. Small ingrowths do not usually present any visual problems and need only to be monitored. The donor cornea must be prepared with a slightly more complicated technique than in standard corneal transplant surgery. If this procedure is not successful, the cornea may not be suitable for transplantation. Dr. Arffa or Dr. Busin will make every effort to make sure that a second cornea is available. However, in some cases surgery may have to be cancelled and rescheduled. If the endokeratoplasty technique is not successful in restoring healthy endothelial cells and a clear cornea, standard corneal transplant surgery can be performed. It is expected that the chance of success of this surgery will not be impaired by the lap joint keratoplasty procedure. Only a small number of patients have undergone lap joint keratoplasty, and observation of those patients has only been for a short period. Therefore the exact risks, both short and long-term, and their likelihood are not fully known. If other complications are encountered during this study, you will be informed of them. Cornea after Lap-joint keratoplasty with suture still in (left) and after suture was removed (right) Benefits Of Lap Joint Keratoplasty Based on our experience with this procedure and with other related procedures, we think that there are potential benefits of lap joint keratoplasty over current corneal transplant techniques. The researchers hope that this technique will result in more rapid healing, that should permit fitting with new glasses or a contact lens approximately 4 months after surgery (instead of 6 to 15 months with the current technique). Also, we hope that astigmatism or distortion of the corneal surface will be less than with the current technique. 5 By serving as one of the early patients to undergo lap joint keratoplasty, you will benefit others. If this technique proves to be superior, it will be used to improve the sight of thousands of other people with endothelial failure. Alternative Procedures The only way to improve your vision is through corneal transplantation. Standard corneal transplantation through penetrating keratoplasty is successful in a high percentage of cases. Approximately 85% of patients undergoing penetrating keratoplasty will obtain a clear cornea. However, it takes approximately one year for the wound to heal sufficiently to permit removal of all supporting stitches. In most cases good vision must await prescription of new glasses, and this can not be done for at least 6 months, and in some cases not until after all stitches are removed one year after surgery. Distortion or deviation from a spherical curvature, or astigmatism, is very likely after penetrating keratoplasty. In most cases this astigmatism can be corrected with glasses. In some cases good vision can only be obtained with a rigid contact lens, or through surgical reduction of astigmatism. Follow-up Visits and Examinations All patients will be seen in Dr. Arffa’s office at the following times after surgery: 1 week, 1 month, 2 months, 3 months, 6 months, and 1 year. These visits are necessary after traditional corneal transplant surgery as well. During these visits eye examinations may include determination of your vision with and without glasses or contact lens, obtaining a computer-analyzed photograph of the surface of your new cornea, measurement of intraocular pressure, measurement of cornea thickness using ultrasound, and photographing the cells on the back of the cornea (specular microscopy). None of these tests are painful or pose a risk of injury to your eye. They are standard examination techniques typically performed after corneal transplantation. 6