NCT03675438

Safety and Efficacy of a Sub-epitheilal Transform™ Corneal Allograft (TCA) for Presbyopia Correction

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Allotex, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Presbyopia
• Refractive Errors

Interventions

Type	Name	Description
OTHER	Sub-epitheilal TCA Inlay	A TCA lenticule is placed at the sub-epithelial interface with the anterior surface of Bowmans layer

Timeline

• Start date: 2018-10-01
• Primary completion: 2021-01-01
• Completion: 2021-01-01
• First posted: 2018-09-18
• Last updated: 2020-03-11

Locations

11 sites across 6 countries: Austria, Belgium, France, Ireland, Switzerland, United Kingdom