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First Author: J.Meyer USA
Co Author(s): B. Soloway
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To evaluate the effect on preferred near distance after bilateral placement of Scleral Implants in a multi-center investigational devise exemption (IDE) clinical trial for treatment of presbyopia.
14 sites across the United States in a 2 year controlled study.
Three hundred thirty (330) presbyopic emmetropes were recruited in this study. Primary eye eligibility criteria included: best corrected distance visual acuity (BCDVA) = 20/20; manifest refraction spherical equivalent (MRSE) between +0.75D and -0.50D, with ? 1.00D of astigmatism; distance corrected near visual acuity (DCNVA) between 20/50 and 20/100. During the procedure, PresVIEWTM ScleraI Implants are placed circumferentially in the oblique quadrants of the sclera just posterior to the calculated lens equator. The fellow eye is also implanted no sooner than 15 days following the primary eye. Near visual acuity at the patients preferred distance was assessed using the ETDRS 2000 near vision chart under standardized mesopic illumination. Measures were obtained pre-operatively and at 6, 12, 18 and 24 months post-operatively.
The PresVIEWTM Procedure has been performed on 645 eyes of 330 patients. Preliminary descriptive analyses of patient preferred near distance of the primary eye for DCNVA decreased during the study. The mean patient preferred near distance decreased for patients by 17.6 cm from 54.3 cm to 36.7 cm (n=259) at the 6 month visit, by 15.1 cm from 51.9 cm to 36.8 cm (n=125) at the 12 month visit, by 13.7 from 50.3 to 36.6 cm (n=85) at the 18 month visit, and by 13.1 cm from 49.8 cm to 36.7 cm (n= 50) at the 24 month visit. The mean distances are respective of cohort. The mean patient preferred distance at all post-operative visits was approximately 37 cm.
These preliminary results suggest that the PresVIEWTM Procedure using the Scleral Implant device resulted in a reduction in preferred DCNVA near distance, i.e., patients now have the ability to focus at a much closer near point.