Treatment of Presbyopia Using Novel Surgical Procedure: Bilateral Improvement in Subjective Near and Intermediate Vision
Narrative Responses:
Purpose
To assess the visual performance of emmetropic presbyopes after bilateral placement of Refocus Scleral Implants (Refocus Group, Dallas, TX) in a 2-year multi-center IDE clinical trial. This paper discusses the improvement in bilateral near and intermediate vision observed at our site following this treatment.
Methods
Twenty six presbyopic emmetropic subjects were recruited and met the inclusion criteria of best corrected distance visual acuity (BCDVA) of 20/20, with a manifest refraction spherical equivalent (MRSE) between +0.75D and -0.50D, with ≤ 1.00D of astigmatism. Distance corrected near visual acuity (DCNVA) was between 20/50 and 20/100. During the Refocus Procedure, four Refocus Scleral Implants were placed circumferentially in the oblique quadrants of the sclera, 4mm posterior to the limbus. Bilateral improvement in unaided near and intermediate visual function was obtained subjectively using a questionnaire at the baseline, 3, 12 and 24 month study visits.
Results
The Refocus Procedure was performed on 26 primary and 26 fellow eyes (N=52, mean pre-op DCNVA=20/72, mean age = 54.3 years, mean MRSE = +0.36D). The percentage of subjects reporting excellent-acceptable intermediate/computer vision increased from 15% at baseline to 96% at 3 months. The percentage of subjects reporting the ability to read newspapers at an excellent-acceptable level increased from 4% to 84% at 3 months. At 12 months, 87% rate their near vision as better or significantly better compared to baseline. Distance vision was not affected.
Conclusion
The preliminary results suggest that the Refocus Scleral Implants are effective in restoring near and intermediate vision in emmetropic presbyopes. The improvement is bilateral and clinically significant by 3 months and beyond. All patients have maintained binocular distance vision, as the procedure is performed outside the visual axis.