First Author: D.Schanzlin USA
Co Author(s): B. Soloway
Purpose:
To evaluate the change in near acuity with PresViewTM Scleral Implants (PSI) and Scleral Spacing Procedure (SSP) in the US FDA clinical trial.
Setting:
Prospective Multicentered Clinical Trial
Methods:
A prospective multicenter clinical trial to test the safety and efficacy of PSI using the SSP to improve unaided near vision in presbyopic emmetropes is being performed binocularly (in most cases) under standardized mesopic illumination at 40cm on up to 660 eyes in 330 patients. Patient selection requirements included: 20/20 DCVA, Manifest Refraction SE of between +0.75D with 1.00D or less astigmatism, 20/50 to 20/100 distance corrected near vision (DCNVA). Four PSI are placed circumferentially in the sclera. Immediately post-op, long term collagen punctual plugs were placed. Patients were instructed to use aggressive artificial tear drops and to increase illumination in favor of using glasses when reading.
Results:
To date, 174 primary (average baseline DCNVA of 20/70) and 146 fellow eyes (average baseline DCNVA of 20/72) have received SSP (average baseline DCNVA of 20/71, combined). At 6, 12, 18 and 24 months, the percentage of eyes reaching 20/40 or better DCNVA were 71% (n=114), 94% (n=53), 82% (n=33), and 94% (n=18), respectively. All 24 month endpoints with regard to the FDA hurdles have been met.
Conclusions:
These interim results of the PresView (PSI) device demonstrate the safety and efficacy of this method in restoring near acuity in the presbyopic patient. FINANCIAL DISCLOSURE?: ... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented
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