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

Allotex, Inc.5 sites in 4 countries71 target enrollmentFebruary 13, 2024

ConditionsPresbyopia

Overview

Phase: N/A
Intervention: Not specified
Conditions: Presbyopia
Sponsor: Allotex, Inc.
Enrollment: 71
Locations: 5
Primary Endpoint: An exploratory data collection project with no primary safety or effectiveness endpoints.
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

February 13, 2024

End Date

November 22, 2024

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Allotex, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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.