Safety and Efficacy of an Intrastromal Transform Corneal Allograft (TCA) for Presbyopia Correction - Long Term Follow-up

December 18, 2024 updated by: Allotex, Inc.

A Prospective Multicenter Clinical Study to Evaluate the Safety and Effectiveness of Intrastromal Implantation of the Transform Corneal Allograft (TCA) for Providing Near Vision in Presbyopic Subjects - Long Term Follow-up

The objective of this clinical study is to evaluate the long term safety and effectiveness of intrastromal implantation of the Allotex TransForm corneal allograft (TCA) for providing near vision in presbyopic subjects.

A maximum of 101 eyes of qualified and consented subjects will undergo long term follow-up after instrastromal implantation of the TCA for presbyopia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

71

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Zlín, Czechia, 760 01
        • Gemini - Oční klinika Zlín
  • Ireland
      • Dublin, Ireland, D18 T8P3
        • Wellington Eye Clinic
  • Turkey
      • Istanbul, Turkey, 34214
        • Medipol University
  • United Kingdom
      • East Grinstead, United Kingdom, RH19 4RH
        • Centre For Sight
      • London, United Kingdom, W1G 8GQ
        • Eye Clinic London
      • London, United Kingdom, W1G 9LG
        • Centre For Sight
      • Oxshott, United Kingdom, KT22 0JR
        • Centre For Sight

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

A maximum of 101 eyes of qualified and consented subjects will undergo long term follow-up after instrastromal implantation of the TCA for presbyopia.

Description

Inclusion Criteria:

  • Provide informed consent, have signed the written informed consent form, and been given a copy.
  • Subjects must be willing and able to return for one scheduled follow-up examinations.
  • Subjects must have undergone implantation with the TCA under study protocol PRO-010 between April 24, 2019 and October 31, 2019.

Exclusion Criteria:

• There are no known exclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
An exploratory data collection project with no primary safety or effectiveness endpoints.
Time Frame: 4 years or more after TCA implantation
An exploratory data collection project with no primary safety or effectiveness endpoints.
4 years or more after TCA implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allotex, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2024

Primary Completion (Actual)

November 22, 2024

Study Completion (Actual)

November 22, 2024

Study Registration Dates

First Submitted

February 29, 2024

First Submitted That Met QC Criteria

March 7, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 18, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO_010-2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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