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

NCT03675438 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-03-11

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Sub-epitheilal TCA Inlay

A TCA lenticule is placed at the sub-epithelial interface with the anterior surface of Bowmans layer

Sponsors & Collaborators

  • Allotex, Inc.

    lead INDUSTRY

Principal Investigators

  • Peter Hersh, MD · Study Medical Monitor/Consultant

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-31
Primary Completion
2021-01-31
Completion
2021-01-31

Countries

  • Austria
  • Belgium
  • France
  • Ireland
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03675438 on ClinicalTrials.gov