Clinical Trials
Allotex is currently investigating the TransForm™ Corneal Allograft (TCA) via:
A prospective multi-center clinical study to evaluate the safety and effectiveness of intrastromal implantation of the TCA for providing near vision in presbyopic subjects.
The objective of this clinical study is to evaluate the safety and effectiveness of intrastromal implantation of the Allotex TCA for providing near vision in presbyopic subjects correction of hypopia.
The study is being led by Medical Monitor Vance Thompson, MD and is being conducted in the following locations, led by respective local monitors. A subset of clinical trial locations is below:
- France
- Ireland
- Turkey
- United Kingdom
- Austria
- Switzerland
- Belgium
- Slovakia
The TCA is indicated for intrastromal implantation to provide near vision in the non-dominant eye of presbyopic patients, 41 to 65 years of age, who have manifest refraction spherical equivalent of +1.00 diopters (“D”) to -0.75 D with ≤0.75 D of refractive cylinder, do not require correction for clear distance vision, but do require near correction of +1.75 D to +3.50 D of reading add.