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First Author: B.Soloway USA
Co Author(s): D. Schanzlin
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To discuss advancements in the device, instrumentation and technique of the PresViewTM (Refocus-Group, Dallas, TX) procedure using the PresViewTM Scleral Implant (PSI) in the US IDE and international clinical trials for presbyopia.
Prospective randomized control investigational device exemption (IDE) clinical trial at fourteen sites in the United States
PresViewTM IDE clinical trials began in March 2000 with completion of enrollment in September 2012. Over this time, numerous innovations in the PSI device, the surgical instrumentation and the procedure have been made. The IDE study cohort to date includes 860 eyes of 494 patients. 647 eyes of 330 patients have received the current PSI design in this group. The primary outcome parameter of distance corrected near visual acuity (DCNVA) is evaluated under uniform conditions at intervals post-op to monitor the efficacy of the procedure. Additional metrics including intra-ocular pressure (IOP) are also collected during these visits
Patients implanted with the current generation PSI at the investigation sites in the IDE clinical trial have shown increased improvement in DCNVA with greater stability over time as compared to earlier generations. Pre-operative mean monocular DCNVA in this final cohort was = 20/75. At the two year milestone, 97% of the eyes had a DCNVA of 20/40 or better and an average IOP reduction of 21%. Improved stability was evidenced by the continual improvement seen throughout the course of the study
Advancements in PSI design, instrumentation and surgical technique have standardized and simplified the PresViewTM procedure. Compared to earlier designs, techniques and instrumentation, a greater number of patients treated by a wider variety of surgeons now meet or exceed the primary outcome efficacy of DCNVA 20/40 or better as set for this procedure. The two piece locking PSI has yielded a more stable and longer lasting improvement in DCNVA and decreased IOP.
... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, ... travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, ... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented