Improvement of near vision in presbyopes after scleral spacing procedure (SSP) with polymethyl methacrylate (PMMA) Implants for Presbyopia: my first year results during food and drug administration (FDA) monitored clinical trials

Poster Details

First Author: J.Meyer USA

Co Author(s):                  

Abstract Details

Purpose:

To evaluate the improvement in near vision after SSP with PresViewTM Scleral Implants (PSI) at one site in the US FDA clinical trial.

Setting:

All procedures were performed in a single private practice in Louisville, KY USA by the author.

Methods:

Subjects aged 50 to 60 years old and within spherical equivalent ±0.75 diopters were enrolled in a randomized prospective investigational device exemption (IDE) study. Near Sloan Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity was tested monocularly and binocularly at 40cm in photopic uniform light with and without distance correction pre-op and at three month intervals.

Results:

An interim report of the results achieved at The Eye Care Institute in Louisville, KY USA within this FDA monitored IDE clinical trial will be given. A comparison of the subject's pre-op, 3 month and 6 month data during the first full year of participation will be reported.

Conclusions:

SSP with PSI is currently being studied under an FDA IDE at multiple sites in the USA. Results to date are showing significant and temporally progressive improvements in near acuity in these presbyopic subjects, with expected binocular acuity improvements over monocular. FINANCIAL DISCLOSURE?: No