Effect of Refinements in Surgical Instrumentation and Scleral Implant Device and Technique on Presbyopia Treatment
Narrative Responses:
Purpose
To discuss advancements in the device, instrumentation and technique of the Refocus Procedure (Refocus-Group, Dallas, TX) using the Refocus Scleral Implant in the US IDE and international clinical trials for presbyopia.
Methods
Refocus IDE clinical trials began in March 2000 with completion of enrollment in October 2012. Over this time, numerous innovations in the Refocus Scleral Implant device, the surgical instrumentation and the procedure have been made. The IDE study cohort to date includes 858 eyes of 494 patients. A total of 645 eyes of 330 patients have received the current implant design. The primary outcome parameter of distance corrected near visual acuity (DCNVA) is evaluated under uniform conditions at intervals post-operatively to monitor the efficacy of the procedure. Additional metrics including intra-ocular pressure (IOP) are also collected during these visits.
Results
Patients implanted with the current generation Refocus Scleral Implant 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 = 20/73. At the two year milestone, 93% of eyes had DCNVA of 20/40 or better and an average IOP reduction of 14%. Improved stability was evidenced by the continual improvement seen throughout the course of the study. The two piece locking implant has yielded a more stable and longer lasting improvement in DCNVA and decreased IOP.
Conclusion
Advancements in implant design, instrumentation and surgical technique have standardized and simplified the Refocus Procedure. Now a greater number of patients treated by a wider variety of surgeons meet or exceed the primary outcome efficacy of DCNVA 20/40 or better.