Are You a Candidate?
If you're 40 or over and depend on glasses or contact lenses to correct low to moderate farsightedness, SUNRISE LTK™ was developed just for you. To determine if LTK is right for you, you'll need to schedule an appointment with Dr. Gary Kawesch for a complete eye evaluation. The purpose of this evaluation is to test your vision to pinpoint your exact need. An evaluation is required to determine the cause of your poor vision. Once a diagnosis has been made, a recommendation will follow as to whether the LTK Procedure is the right choice for you.

Watch Dr. Kawesch on KNTV as he describes the LTK procedure:

How Your Vision Can Change After 40
The SUNRISE LTK™ procedure is designed specifically for people age 40 and older who have low to moderate farsightedness. If you've been farsighted all your life or if you've suddenly noticed you need glasses when you didn't need them before, SUNRISE LTK may be the option for you. SUNRISE LTK candidates are people who have low to moderate levels of farsightedness and astigmatism, and otherwise healthy eyes.

How Does LTK Work?
Laser Thermal Keratoplasty (LTK) uses a beam of laser energy to gently reshape the cornea (outer layer of the eye). SUNRISE LTK is a non-contact laser procedure. There's no need to cut the cornea and nothing touches your eye before, during, or after the procedure except for the laser beam itself and an instrument to hold your eye open. The SUNRISE LTK Procedure is so fast that the laser application takes about three seconds per eye. Laser pulses are directed at the cornea, outside of your visual axis (View Animation). The laser energy shrinks the collagen fibers to steepen the cornea . The SUNRISE HYPERION™ LTK System utilizes a patented process for shrinking collagen developed by Dr. Bruce Sand (the "Bruce Sand Process"). This changes the eye's focal point. In most cases, the result is an immediate, noticeable improvement in vision.

What Should I Expect?
The first step in the SUNRISE LTK™ Procedure is the application of a series of anesthetic eye drops. Then, you'll place your chin on a padded chin-rest that keeps your head from moving and that allows Dr. Kawesch to precisely aim the laser. You will be asked to hold still and to focus on a flashing yellow light. Then, the laser energy will be applied for about three seconds. The same procedure will be followed for the second eye. Most people go home within 30 minutes of the SUNRISE LTK Procedure. Dr. Kawesch will probably give you eye drops to use in the short-term and will discuss any other medicines you may need.

The Benefits Are Clear
Because there is no cutting during the procedure, SUNRISE LTK is fast and virtually painless. You may experience some discomfort, scratchiness, or a foreign body sensation for typically 24 to 48 hours. In clinical studies, the incidence of adverse events was low (<1%). Most people are delighted with the convenience of SUNRISE LTK. Both eyes can usually be treated the same day, and the entire procedure can be done our office. Best of all, most people experience an immediate improvement in vision. Dr. Gary Kawesch will provide a complete description of benefits and risks.

Risks & Benefits
Brief Statement: The SUNRISE HYPERION™ LTK System is indicated for: Temporary reduction of hyperopia in patients with +0.75 to +2.5 diopters of manifest refraction spherical equivalent (MRSE) at the spectacle plane (with cylinder less than or equal to ±0.75 diopters) who are 40 years of age or older with documented stability of refraction for the prior 6 months, as demonstrated by a change of less than or equal to 0.50D in spherical and cylindrical components of the manifest refraction. The magnitude of correction with this treatment diminishes over time, with some patients retaining some or all of their refractive correction.

Contraindications: LTK is contraindicated: In pregnant or nursing women. In patients with signs of keratoconus. In patients with clinically significant corneal dystrophy or scarring in the 6 or 7 mm central zone. In patients with a history of herpetic keratitis. In patients with an autoimmune disease, collagen vascular disease, clinically significant atopic syndrome, insulin dependent diabetes or an immune compromised state.

Warnings: Based upon existing information for the clinical parameters used in the clinical trial, the Sponsor's model for the average longevity for the procedure indicates that some of the effect lasts 10 years or beyond. Age related drift towards hyperopia contributes to the loss of effect after the initial two years. Over-correction is anticipated within the first 6 months and may cause changes in both near and distance acuity. This over-correction and the rate of return to emmetropia is displayed in Tables.(click here) The safety and effectiveness of re-treatment procedures with the HYPERION™ LTK System or other refractive surgical devices have not been established. Limited data suggests that the reduction in refractive error following re-treatment may diminish over time. Patient-related warnings: Patients must refrain from wearing contact lenses 2-4 weeks before his or her eye exam (2 weeks prior for soft/permeable lenses; 3 weeks prior for hard lenses). Patients must be able to fixate on the flashing fixation light. Movement during the procedure could result in undercorrection and/or astigmatism.

Precautions: Under-corrections are more likely to occur in younger patients and greater applied energy may be needed. Outcomes are affected by age and applied energy. See Section 6 of the Physician Labeling. The safety and effectiveness of the LTK System has not been determined for use: In patients with progressive hyperopia, ocular disease, corneal abnormality, or trauma in the ablation zone. In patients with glaucoma. In patients under 40 years of age. In long term studies (over 2 years follow-up after procedure). In patients with nystagmus. In patients with cloudy corneas or anterior chambers. In patients with uncontrolled uveitis, severe blepharitis, lagophthalmos or dry eye.

Conditions of Approval Restrictions on Use:

1. Only licensed practitioners who are experienced in the medical management and surgical treatment of the cornea, who have been trained in system calibration and operation to perform laser thermal keratoplasty (LTK) for hyperopia, may use the device as approved in this order.

2. In advance of surgery, all prospective patients must receive the Patient Information Booklet from their treatment provider.

3. Prior to undergoing surgery, prospective patients must be informed of the alternatives for correcting their hyperopia including eyeglasses, contact lenses and other refractive surgeries.

4. Prior to undergoing surgery, prospective patients must be informed that the treatment is probably temporary and the effects of retreatment are not known at this time.

5a. Approval of the premarket approval application for the Sunrise HYPERION™ LTK System is for the temporary reduction of hyperopia in patients with +0.75 to +2.5 diopters of MRSE with less than or equal to ± 0.75 diopters of astigmatism who are 40 years of age or older with documented stability of refraction for the prior 6 months, as demonstrated by a change of less than or equal to 0.50D in spherical and cylindrical components of the manifest refraction. The magnitude of correction with this treatment diminishes over time, with some patients retaining some or all of their refractive correction.

5b. LTK is an elective procedure with the alternatives including, but not limited to, eyeglasses, contact lenses, photorefractive keratectomy (PRK), or laser in situ keratomileusis (LASIK).

5c. Approval of the application is based on a clinical trial of 612 eyes (379 primary and 233 secondary). Of all eyes treated, 571 eyes were available for analysis at 3 months, 555 eyes were available for analysis at six months, 493 eyes were available for analysis at twelve months, and 72 eyes were followed for two years or more. Accountability was 95.5% at 3 months, 93.9% at 6 months, 92.5% at 12 months, and 92.3% at 24 months.

5d. The data analysis was based on the refractive data at all follow-up examination time points (1 month, 3, 6, 12, 18 and 24 months). At 12 months, this analysis showed that 407/409 (85.0%) eyes were corrected to 20/40 or better and 179/479 (37.4%) were corrected to 20/20 or better visual acuity without spectacles or contact lenses. 5e. The study showed that all adverse events occurred at low rates (<1%).

5f. Long term risks of LTK for hyperopia have not been determined. The safety and effectiveness of re-treatment procedures with the HYPERION™ LTK System or other refractive surgical devices have not been established. Limited data suggests that the reduction in refractive error following re-treatment may diminish over time.

What is CK?
Conductive Keratoplasty (CK) is a non-laser surgical procedure available to treat farsightedness. CK uses radiofrequency energy delivered with a needle-like probe to the cornea. The electrical resistance of the collagen causes heat to build up in the cornea, shrinking the collagen and causing the central cornea to steepen.

Who is a candidate for CK?
CK is FDA-approved for patients with farsightedness between +0.75D and 3.00D, with less than or equal to 0.75D of astigmatism.

CK vs. LASIK, advantages and disadvantages
CK’s main advantage is that the center of the cornea is not treated, as it is with excimer laser procedures like LASIK and PRK. Also, there seems to be less dryness of the eye post-CK compared to post-LASIK. The disadvantages of CK compared to LASIK include the wearing-off of the effect of surgery with CK (the FDA notes it is approved for the “temporary reduction” of farsightedness), CK is limited to small amounts of correction, and it is unable to treat astigmatism. LASIK and PRK are able to treat astigmatism. The vision immediately after CK is blurry, and takes a few days to weeks to become clear. LASIK usually gives good vision within a day. Also, the long-term effects of radiofrequency energy to the cornea are not as well known as the long-term effects of excimer laser energy to the cornea (LASIK and PRK).

CK vs. LTK, advantages and disadvantages
LTK (laser thermal keratoplasty) is very similar to CK, in that thermal energy is delivered to the cornea to shrink the corneal collagen. LTK uses a laser to generate the thermal energy. CK’s main advantage over LTK is there seems to be less wearing off of effect with CK. LTK’s advantage over CK is there is no surgical instrument touching the cornea with LTK. Also, there is more long-term data with LTK than there is with CK.

What are the results of CK?
In the FDA studies, 12 months after treatment, 81% of CK patients said they were “satisfied” with the results. 50% said they were “very satisfied.” 18% of patients needed glasses for distance one year following their CK surgery.

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