CompletedNot Applicable

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

Czechia, Ireland, Turkey (Türkiye)71 participantsStarted 2024-02-13

Plain-language 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.

Who can participate

SexALL

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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.

What they're measuring

An exploratory data collection project with no primary safety or effectiveness endpoints.

Timeframe: 4 years or more after TCA implantation

Trial details

NCT IDNCT06310252

SponsorAllotex, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-11-22

View on ClinicalTrials.gov More Presbyopia trials