First Author: B.Soloway USA
Co Author(s): M. Wang M. George A. Sudtelgte
Purpose:
To evaluate the change in near acuity with PresViewTM Scleral Implants (PSI) and Scleral Spacing Procedure (SSP) at one site in the US FDA clinical trial.
Setting:
Wang Vision Institute, Nashville, TN.
Methods:
In a randomized prospective IDE study, near emmetropic presbyopes have careful documentation of their baseline near acuity. After SSP is performed with PSI, re-evaluation of these vision parameters are performed at various intervals. All testing is performed under standardized mesopic illumination.
Results:
An interim report of the results at Wang Vision Institute in this FDA monitored IDE clinical trial will be discussed. A comparison of the subjects pre-op, 3 month, 6 month, 1 year, 18 month and 2 year data will be reported.
Conclusions:
SSP with PSI is currently being studied under an FDA IDE at multiple sites in the USA. All subjects will be followed for a full two years after surgery. Results to date are showing improvements in near acuity in these presbyopic subjects. FINANCIAL DISCLOSURE?: No
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