- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06310252
Safety and Efficacy of an Intrastromal Transform Corneal Allograft (TCA) for Presbyopia Correction - Long Term Follow-up
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Zlín, Czechia, 760 01
- Recruiting
- Gemini - Oční klinika Zlín
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Contact:
- Stodůlka
- Phone Number: +420 577 202 202
- Email: info@gemini.cz
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Dublin, Ireland, D18 T8P3
- Not yet recruiting
- Wellington Eye Clinic
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Istanbul, Turkey, 34214
- Recruiting
- Medipol University
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Contact:
- Tanriverdi
- Phone Number: +904447044
- Email: international@medipol.com.tr
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East Grinstead, United Kingdom, RH149 4RH
- Not yet recruiting
- Centre For Sight
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
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An exploratory data collection project with no primary safety or effectiveness endpoints.
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4 years or more after TCA implantation
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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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