Presbyopia Clinical Trial
Official title:
A Prospective Multicenter Clinical Study to Evaluate the Safety and Effectiveness of Subepithelial Implantation of the Transform Corneal Allograft (TCA) for Improving Near Vision in Presbyopic Subjects
The objective of this clinical study is to evaluate the safety and effectiveness of subepithelial implantation of the Allotex TransForm corneal allograft (TCA) for improving near vision in presbyopic subjects.
Beginning in 1949 with the pioneering work of Jose Barraquer, there has been an interest in
using natural corneal tissue to change the refractive properties of the eye. In recent years,
non-allogenic, synthetic corneal implants have received marketing approval in the United
Stated and Europe for refractive purposes. Although synthetic implants are made of
biocompatible materials they are not equivalent to an allogenic implant in terms of
biocompatibility. The Allotex TCA is a piece of acellular cornea, sterilized with electron
beam radiation and shaped to a particular shape using a laser. The availability of precise
laser shaping systems and sterile corneas are the key factors that make the use of allogenic
implants possible.
The TCA is applied to the surface of Bowman's membrane just underneath the epithelium. The
goal is to enhance the visual performance of the patient with a material that is 100%
biocompatible and precisely shaped for the individual's needs.
Subjects must be presbyopic adults, needing from +1.75 D to +3.50 D of reading add in the
non-dominant eye and must have uncorrected near visual acuity worse than 20/40 in the
non-dominant eye. Bilateral treatments will not be allowed during this study.
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