Columbus, OH—Though enrollment was only recently completed in a pivotal study evaluating a novel scleral implant surgery system (VisAbility Micro-Inserts, Refocus Group) as a solution for presbyopia, anecdotal reports from investigators in the phase III study are very encouraging.
Primary outcome data are being collected after 12 months of follow-up, and so it will be some time before those results are available.
Ken Beckman, MD, entered 14 patients at his site, Comprehensive Eyecare of Central Ohio, Westerville, and noted patients are all doing well and are very happy having undergone the procedure.
With postoperative follow-up ranging between 6 and 9 months, the patients are benefiting from good uncorrected vision at near and intermediate without experiencing loss of distance vision or significant safety issues, said Dr. Beckman, clinical assistant professor of ophthalmology, The Ohio State University, Columbus.
“This is an exciting new procedure for presbyopia that is very easy to perform, provides gratifying results, and has many advantages compared with other surgical presbyopia solutions,” Dr. Beckman said. “The scleral implant procedure is binocular, provides a full range of vision, does not affect the visual axis or induce optical aberrations, and it is reversible.”
The implant system is an investigational device and is limited by United States law to investigational use. This device holds a CE mark and is currently for sale and use in the European Union.