The use of accelerated CXL is currently being investigated at approximately 83 clinical sites in the United States as part of a study sponsored by the American-European Congress of Ophthalmic Surgery or AECOS and conducted by Avedro.
The phase 3, multicenter, randomized controlled ACOS-KXL-001 study is designed to evaluate the safety and efficacy of the KXL System with VibeX (riboflavin ophthalmic solution; both by Avedro) for impeding the progression of and/or reducing maximum corneal curvature in keratoconus or corneal ectasia after refractive surgery. Three doses of irradiation are being evaluated in the study: 15 mW/cm2 for 8 minutes, 30 mW/cm2 for 4 minutes, and 45 mW/cm2 for 2 minutes and 40 seconds. All treatments are being performed with the epithelium removed.
The study was designed to enroll up to 2,000 study eyes with keratoconus and up to 2,000 study eyes with corneal ectasia following refractive surgery. Patients aged 12 years and older are being randomized to one of the three treatment groups by active treatment condition. All study eyes are being treated, and all fellow eyes that meet the criteria have access to treatment.
The primary outcome measure of the study is the mean change in maximum corneal curvature (Kmax) from baseline. The secondary outcome measure is a comparison of treatment groups within each treatment indication.
At the 2015 AECOS Summer Symposium in Deer Valley, Utah, John A. Vukich, MD, principal investigator of ACOS-KXL-001, presented an intermediate analysis of the study data. Dr. Vukich reported that the diagnostic-specific results showed larger effects for keratoconus than for ectasia. In patients with keratoconus, all three treatment groups have shown improvement.
“We are seeing the maximum effect at the longer treatment and lower intensity,” Dr. Vukich said, adding that the investigators are looking to determine if CXL may be not only dose dependent but also time dependent.
A similar trend in improvement was seen in patients with ectasia, although the results are not yet statistically significant. “If we could at least seek stability, that in itself is a very desirable outcome in these very challenging patients,” Dr. Vukich said.
The study, which began in July 2012, has an estimated primary completion date of January 2016.
additional studies on Accelerated CXL
For more on the safety and efficacy of this approach, see:
Ready to Claim Your Credits?
You have attempts to pass this post-test. Take your time and review carefully before submitting.
Good luck!
