FOR IMMEDIATE RELEASE
A joint panel and scientific advisory committee recently voted to recommend FDA approval for a corneal crosslinking treatment, which uses a riboflavin ophthalmic solution and ultraviolet light for progressive Keracotonus and Corneal Ectasia following refractive surgery. The Atlanta Vision Institute for LASIK in Atlanta is in favor of this approval.
The Atlanta Vision Institute for LASIK in Atlanta applauds the recent recommended FDA approval of corneal crosslinking. On February 24, 2015, members of the FDA’s Dermatologic and Ophthalmic Drugs and Advisory Committee and the Opthalmic Devices Panel gathered to determine whether or not to recommend FDA approval for a corneal crosslinking treatment. The treatment involves a combination of a riboflavin ophthalmic solution followed by exposure to UVA light to chemically strengthen collagen in the cornea. This is used for the treatment of both Keratoconus and Corneal Ectasia following refractive surgery. After reviewing clinical trials and analyzing medical testimonies regarding the treatment, the joint advisory panel has decided to recommend FDA approval.
Keratoconus is caused by the weakening of collagen fibers in the cornea, allowing internal eye pressure to cause corneal bulging. This results in a variety of accompanying vision problems, including distortion, double vision, glares, blurred vision and general vision deterioration. A progressive disease, Keratoconus can impair vision to the point of legal blindness. Corneal Ectasia, a similar condition, is a rare long term side effect of refractive eye surgery. After LASIK or other laser eye surgeries, the cornea weakens and becomes more susceptible to bulging, which leads to Ectasia. The exact occurrence of Ectasia is unclear, but it is estimated to be less than one percent.
This corneal crosslinking treatment is a drug-device combination involving dousing the affected eye with an ophthalmic solution of riboflavin, and then exposing the eye to UVA light. This photochemical procedure causes collagen fibers to stiffen, helping stop the progression of corneal bulging in Keratoconus and Ectasia patients. While there are some risks to be considered, the benefits of this relatively simple procedure are substantial. Previously, corneal transplants were the only option for patients with extreme disease progression.
The procedure has undergone uncontrolled observational trials and prospective clinical trials, which have demonstrated the safety and efficacy of corneal crosslinking. The FDA advisory panel determined the medical necessity of the crosslinking procedure for patients suffering from Keratoconus and Corneal Ectasia. It was concluded that the trials and research adequately demonstrated safety, value and effectiveness of the treatment. Corneal crosslinking has been available in Europe and Asia for years, and is now well on its way to becoming available for United States patients; a final decision will be determined on March 29, 2015. The Atlanta Vision Institute is looking forward to the opportunity of offering its patients this potentially life-changing treatment option.
“This was long overdue. Cross-linking has been the standard of care for the treatment of Keratoconus outside the United States for many years,” said Dr. Farooq Ashraf, founder of the Atlanta Vision Institute. “Now my U.S. patients can have the same treatment options as our international patients.”
About the Atlanta Vision Institute:
Dr. Ashraf is the founder of the Atlanta Vision Institute and is a board-certified ophthalmologist who specializes in corneal and refractive surgery, as well as other treatments for astigmatism, glaucoma, cataracts and other eye conditions. He obtained his advanced training in ocular surgery at Johns Hopkins University and has performed over 40,000 LASIK procedures. In addition to his Atlanta practice, Dr. Ashraf has also founded the Atlanta Vision Clinic in Dubai, UAE. For more information, visit https://www.atlanta2020.com/.