Multicenter FDA Clinical Trial of Treatment of Presbyopia Using Scleral Implants: Preliminary Findings
Narrative Responses:
Purpose
To evaluate the effect on distance corrected near visual acuity (DCNVA) after placement of Refocus Scleral Implants (Refocus-Group, Dallas, TX) in a multi-center prospective clinical trial design. The study is being conducted under a U.S. FDA approved IDE.
Methods
Three hundred thirty presbyopic emmetropic patients were recruited in this study. Eligibility criteria include: best corrected distance visual acuity (BCDVA) = 20/20; manifest refraction spherical equivalent (SE) between +0.75D to -0.50D, with ≤ 1.00D of astigmatism; distance corrected near visual acuity (DCNVA) between 20/50 to 20/100. During the Refocus Procedure, four Refocus Scleral Implants are placed circumferentially in the oblique quadrants of the sclera 4 mm posterior to the limbus. DCNVA was the primary outcome measure and was assessed under standardized mesopic illumination at 40 cm pre-operatively and post-operatively at 6, 12, 18 and 24 months.
Results
The Refocus Procedure has been performed on 330 primary eyes (mean pre-op DCNVA = 20/73) and 315 fellow eyes (mean pre-op DCNVA = 20/74), (total N = 645, mean pre-op DCNVA = 20/73). Preliminary descriptive analyses showed that out of all eyes assessed post-operatively at 6, 12, 18 and 24 months, 70% (n=621), 81% (n=581), 84% (n=319), and 93% (n=197), respectively, reached 20/40 or better DCNVA.
Conclusion
These preliminary results suggest that the Refocus Procedure using the Refocus Scleral Implant device was effective in restoring near visual acuity in presbyopic emmetropic patients.