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

Allotex

Status: Completed

Conditions: Presbyopia

Treatments: Diagnostic Test: Opthalmic assessments

Study type: Observational

Funder types: Industry

Identifiers

NCT06310252

PRO_010-2023

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.