Keratoconus Clinical Research Trial
Hudson Valley Keratoconus Clinical Research Trials
It has been estimated that keratoconus occurs in about one out of every two thousand people. It is typically diagnosed when a patient has just reached puberty or is in his or her teen years. While it is commonly seen in younger patients, patients of all ages may develop the condition.
At his laser vision center in Hudson Valley, Dr. Richard Gordon is conducting keratoconus clinical research trials to study an investigational treatment to stop or slow the progression of keratoconus. The study is being conducted in 100 clinical centers across the United States and is being sponsored by the American-European Congress of Ophthalmic Surgery (ACOS). The primary focus of the Phase 3 multi-center, randomized, controlled evaluation is to study accelerated corneal collagen cross-linking in patients diagnosed with keratoconus after undergoing refractive surgery. The effectiveness and safety of using the Avedro’s KXL™ System in conjunction with VibeX™ in the treatment of keratoconus will be evaluated during the clinical research trials.
What Is Keratoconus?
The clear, front surface of the eye - the cornea - normally has a dome shape. In keratoconus, the structure of the cornea begins to thin. Because of this thinning, the cornea cannot hold its round shape and will bulge outward into a cone shape.
The changes in the cornea that occur may happen quickly or gradually over a number of years. Typically, keratoconus affects one eye, and then the other eye. The severity of the condition may differ between eyes.
What Are the Symptoms or Signs of Keratoconus?
Patients affected by keratoconus may experience blurry or distorted vision, difficulty seeing in levels of low light such as at nighttime, sensitivity to bright light, sensitivity to glare, rapidly changing eyeglass prescriptions, and clouding vision. The symptoms of the condition can change as it progresses. For the health of your eyes, it is important to schedule an eye examination if you are experiencing any of these symptoms.
How Is Keratoconus Diagnosed?
Keratoconus can be diagnosed during a comprehensive eye examination. This eye examination will include an eye refraction test, evaluating the shape of the cornea, and evaluating the curvature of the cornea. A keratometry or computerized corneal mapping may be utilized in the evaluation of the surface and shape of the cornea.
Keratoconus Clinical Research Trial
During the study the Avedro’s KXL™ System, an ultraviolet-A illumination device (UVA light treatment), will be used in conjunction with VibeX™ (riboflavin ophthalmic solution) to treat keratoconus. All of the 100 clinical centers conducting the keratoconus clinical research trials will utilize the same treatment protocol. During the study, Avedro’s KXL™ System and VibeX™ eye drops will be administered once to strengthen the cornea. The trial will study whether this treatment is effective at strengthening the cornea to the point of slowing or stopping the progression of keratoconus.
You may qualify to participate for the keratoconus clinical research trial if you are over the age of 18, have been diagnosed with keratoconus after undergoing refractive surgery, such as LASIK or PRK, and are able to meet the time requirements. The study will last from 12 to 18 months after the initial study and will require at least eight visits to our office.
The time commitment for the study is as follows:
- A screening visit to determine your eligibility
- A treatment visit
- Follow-up visits at one day, one week, one month, three months, six months, and 12 months after treatment
- If both eyes are treated, the study may last for 18 months
To Participate in the Study
If you are interested in learning more about the keratoconus clinical research trial, or wish to determine your eligibility, please contact Palisades Laser Eye Center today.