Single-Center Experience With Improvement of Near Visual Acuity Using Scleral Implants for Treatment of Presbyopia: 2-Year Data
Narrative Responses:
Purpose
To evaluate the effect on distance corrected near visual acuity (DCNVA) after placement of Refocus Scleral Implants (Refocus-Group, Dallas, TX) at the center with the longest follow-up in this multi-center prospective IDE clinical trial.
Methods
During the scleral spacing procedure, four Refocus Scleral Implants are circumferentially implanted intra-sclerally in the oblique quadrants just posterior to the lens equator. Patients enrolled in this prospective study were required to have best corrected distance visual acuity (BCDVA) of 20/20 in each eye, manifest refraction spherical equivalent between +0.75D to -0.50D with ≤ 1.00D of astigmatism and distance corrected near visual acuity (DCNVA) between 20/50 to 20/100. The primary outcome of DCNVA was obtained using standardized illumination at 40 cm at all visits. At my center, 63 eyes of 33 patients have had this procedure.
Results
The mean pre-op DCNVA was 20/70 in the 63 eyes enrolled. Post-operatively 87% of the individual eyes reached 20/40 or better DCNVA at 6 months. This improved to 91% at 1 year, 87% at 18 months and 96% at 2 years. Binocular results of 20/40 or better DCNVA were 89% at 6 months, 89% at 1 year, 96% at 18 months and 100% at 2 years. The distribution of binocular DCNVA at 2 years was 100% 20/40, 95% 20/32, 64% 20/25 and 27% 20/20. There were no significant adverse events and no patient had any loss of BCDVA
Conclusion
These results suggest that in our experience, the scleral spacing procedure was effective in restoring near visual acuity in presbyopic emmetropic patients without adverse effects both objectively and subjectively. The improvement in vision increased and has been maintained over the 2 year clinical trial.