Safety and Efficacy of an Intrastromal Transform Corneal Allograft (TCA) for Presbyopia Correction - Long Term Follow-up
Completed
- Conditions
- Presbyopia
- Registration Number
- NCT06310252
- Lead Sponsor
- Allotex, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method An exploratory data collection project with no primary safety or effectiveness endpoints. 4 years or more after TCA implantation An exploratory data collection project with no primary safety or effectiveness endpoints.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Gemini - Oční klinika Zlín
🇨🇿Zlín, Czechia
Wellington Eye Clinic
🇮🇪Dublin, Ireland
Medipol University
🇹🇷Istanbul, Turkey
Centre For Sight
🇬🇧Oxshott, United Kingdom
Eye Clinic London
🇬🇧London, United Kingdom