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

NCT03671096 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL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 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.

Conditions

  • Hyperopia

Interventions

OTHER

Intrastromal TCA Inlay

An intrastromal inlay that will be provided to correct the required hyperopic correction

Sponsors & Collaborators

  • Allotex, Inc.

    lead INDUSTRY

Principal Investigators

  • Stephen Slade, MD · Study Medical Monitor/Consultant

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
65 Years
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

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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 NCT03671096 on ClinicalTrials.gov