AECOS® (American-European Congress of Ophthalmic Surgery) was pleased to sponsor a leading accelerated cross-linking study, ACOS-KXL-001, in which 83 clinical sites offered accelerated cross-linking throughout the US. AECOS received approval from the FDA to initiate the phase 3, multicenter, randomized, controlled evaluation of the safety and efficacy of corneal collagen cross-linking in eyes with keratoconus or corneal ectasia after refractive surgery. The study exclusively utilized Avedro’s riboflavin and KXL system for accelerated cross-linking.  Patients with keratoconus and corneal ectasia were recruited nationwide to evaluate and compare the safety and efficacy of three treatment regimens for corneal collagen cross-linking performed with Avedro’s riboflavin and KXL System for reducing corneal curvature. Corneal collagen cross-linking has been commonly used as the first-line method to restore corneal stability in keratoconic and corneal ectatic eyes in Europe and throughout the world for many years.  The AECOS study was concluded in June 2016 with very favorable results.  It is the largest body of corneal cross-linking data in the world.

Principal Investigators: AECOS Corneal Cross-Linking Clinical Sites:

AECOS is honored to participate in the FDA/CDRH Network of Experts. The program is designed to provide a rapidly accessible virtual network of scientific experts for the CDRH (Center for Devices and Radiological Health) and other staff within the FDA. This collaboration enables an efficient exchange of knowledge that will streamline the resolution of an issue, complaint or the evaluation of a complex medical device. It is meant to supplement existing areas of expertise within the CDRH, and accelerate the availability of safe and innovative medical products. Participants receive no compensation for their services.

AECOS also participated in the development of guidance on Laser Refractive Cataract Surgery. On November 16, 2012, the Centers for Medicare and Medicaid Services published guidance entitled “Laser-Assisted Cataract Surgery and CMS Rulings 05-01 and 1536-4.” The guideline addresses when physicians and facilities may charge Medicare beneficiaries for the use of a femtosecond laser when performing cataract surgery with the implantation of premium IOLs.

On December 17, 2012, AECOS hosted a webinar and live Q & A: “CMS Guidance on Femtosecond Lasers: What it means to physicians and facilities.”