Emory Eye Center First in U.S. to Conduct Innovative Keratoconus Clinical Trial

Emory Eye Center is the first U.S. site to conduct an innovative clinical study on patients with keratoconus. The condition causes a bulging or steepening of the cornea that can lead to, in some cases, scarring of the cornea, or corneal ectasia, a similar condition that can occur after refractive surgery.

The new treatment, a minimally invasive, quick procedure, involves riboflavin eye drops that are applied to the patient's cornea and activated by an ultraviolet light. In European studies, the treatment has been shown to increase the amount of collagen cross-linking in the cornea, thereby strengthening it. Cross-linking refers to the natural collagen "anchors" in the corneal tissue. A stronger cornea will not tend to steepen in the way that a diseased cornea steepens.

The cornea is the clear or transparent front section of the eye, covering the iris and pupil. It lets light through, and its curvature causes light to bend, providing the eye's focusing or refractive power. With keratoconus or corneal ectasia, a typical patient has moderate to very severe blurriness of vision. Keratoconus and corneal ectasia together account for 15 percent of the corneal transplants in the United States.

In the past, managing keratoconus has included at the earliest involvement, glasses and/or rigid gas permeable contact lenses. When the condition has advanced to the corneal scarring point, a corneal transplant may be indicated. About half of keratoconus patients have no real problems with their lifestyle other than corrective lenses. The condition may even stabilize. For others, the condition can be resolved only by penetrating keratoplasty (PKP), often known as corneal transplant or corneal graft. In some cases, keratoconus can reoccur in that grafted cornea.

The new trial, which will include about 300 patients may "revolutionize the practice of cornea and ophthalmic external disease treatments," says R. Doyle Stulting, MD, PhD, a cornea specialist at Emory Eye Center and principal investigator for the clinical trial.

"This therapy represents a revolutionary method of treating a degenerative eye disorder," says Timothy W. Olsen, MD, director of Emory Eye Center and the F. Phinizy Calhoun Sr. Chair of Ophthalmology. "Many people suffer from this condition, and we are excited that Dr. Stulting will treat the very first patients in the United States with this innovative new procedure at the Emory Eye Center. Dr. Stulting's expertise is uniquely suited to conduct this seminal trial that could help stabilize and improve the vision for many affected individuals."

Dr. Stulting explains, "This new treatment shows promise for not only treating keratoconus, but for treating ectasia or keratectasia. It could also be helpful in treating endothelial dystrophy or Fuchs' dystrophy."

Fuchs dystrophy is an inherited condition that affects the delicate inner layer (endothelium) of the cornea It is progressive and patients gradually lose the endothelial cells, leading to corneal clouding and reduced vision.

"In addition," says Dr. Stulting, "the riboflavin treatment may also help those with corneal melting caused by certain auto-immune diseases as well as those with infectious keratitis resistant to traditional antibiotics."

Dr. Stulting has been on the forefront of numerous clinical trials in past years, most notably the seminal FDA trials on LASIK. His areas of expertise include: a variety of refractive surgery procedures, the management of corneal and external eye diseases, corneal transplantation, and cataract surgery.

The clinical trial, called Collagen Cross-Linking with Riboflavin, or CXL, is enrolling patients at Emory at this time; for more information please call 404-778-6155.