NCT03671096

Safety and Efficacy of the Transform™ Corneal Allograft for Hyperopia Correction

A Prospective Multi Center Clinical Study to Evaluate the Safety And Effectiveness of the Transform™ Corneal Allograft (TCA) for Treatment of Hyperopia

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Allotex, Inc. · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The objective of this clinical study is to evaluate the safety and effectiveness of intrastromal implantation of the Allotex TCA for improving distance vision in hyperopic subjects. The overall objective with respect to visual outcome is to provide improved vision without the requirement of additional visual aids.

Detailed description

This research provides a method to primarily correct refractive error by implanting a natural tissue graft. The level of correction will range from +1.00 to +6.00D which represents a range of refractive error that is difficult to manage using the same refractive surgical techniques used to correct myopia. The other objective is to assess graft tolerance and safety so it can be applied to subjects that require other forms of visual correction. This technique also permits the potential for graft removal if required and the patient should revert back to their previous prescription as no tissue is removed when applying this technique. 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 implant is placed on the posterior surface of Bowmans layer of the cornea, in a corneal flap formed by a femtosecond laser.

Conditions

• Hyperopia

Interventions

Type	Name	Description
OTHER	Intrastromal TCA Inlay	An intrastromal inlay that will be provided to correct the required hyperopic correction

Timeline

• Start date: 2018-10-01
• Primary completion: 2021-01-01
• Completion: 2021-01-01
• First posted: 2018-09-14
• Last updated: 2020-03-11

Locations

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