LENSAR Initiates Clinical Study to Evaluate Lens Softening Effects of the LENSAR Laser System
LENSAR Inc., developer of the next-generation LENSAR™ Laser System, today announced that is has opened a clinical study under protocolto evaluate the laser system’s use in softening the crystalline lens in presbyopic patients. The new “LENSAR Laser System Lens Softening Study” will begin this week, with the first 30 eyes/patients. The trial will expand to additional clinical sites by year-end. “We look forward to studying and expanding the body of data on the use of a femtosecond laser for lenticular softening with the eventual goal of accommodation restoration,” said Sunil Shah,M.D., principal investigator of the trial and ophthalmologist at Birmingham and Midland Eye Centre, Birmingham, England. Data from an initial 80-subject advanced feasibility study show the LENSAR Laser System demonstrated the ability to soften the lens and restore accommodation, with notable improvement in best distance corrected near visual acuity (BDCNVA). This feasibility study served as the catalyst for the formal clinical trial and was conducted by Harvey S. Uy, M.D., Pacific Eye and Laser Institute, Metro Manila, Philippines. It will be presented at this week’s AAO annual meeting in New Orleans, LA. “The data from our feasibility trial was promising and worthy of further study,”saidDr.Uy.“We not only found proof of concept, but also improved objective accomodation. We look forward to participating in the next phase of this important clinical trial.” According to Nick Curtis, LENSAR CEO, “The prospect of using the LENSAR Laser System for lenticular softening as a potential treatment for presbyopia represents an exciting and immense new market opportunity for LENSAR. With our original research, and the associated IP,LENSARis uniquely positioned to serve this huge market segment. ”Presbyopia is a condition that, with age, progressively diminishes the ability to focus on near objects. Presbyopia occurs when the crystalline lens inside the eye becomes increasingly rigid and hasless accommodating (zoom) power to focus on near objects. The condition affects more than a billion people in the world, according to the Archives of Ophthalmology.