NCT03671135

Safety and Efficacy of an Intrastromal Transform™ Corneal Allograft (TCA) for Presbyopia Correction

A Prospective Multicenter Clinical Study to Evaluate the Safety and Effectiveness of Intrastromal Implant of the Transform Corneal Allograft (TCA) for Providing Near Vision in Presbyopic Subjects

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 121 (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 intrastromal 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 placed in an intrastromal flap (Just beneath Bowmans layer) created using a femtosecond laser. 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

Interventions

Type	Name	Description
OTHER	TCA Intrastromal Inlay	Anterior surface of Bowmans Layer Corneal Optical Correction Inlay

Timeline

• Start date: 2018-08-09
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2018-09-14
• Last updated: 2024-02-23

Locations

4 sites across 3 countries: Belgium, Ireland, United Kingdom