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NCT06310252 Clinical Trial

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

Presbyopia Clinical Trial

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06310252
Other study ID # PRO_010-2023
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 13, 2024
Est. completion date September 2024

Study information
Verified date March 2024
Source Allotex, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 101
Est. completion date September 2024
Est. primary completion date June 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Opthalmic assessments
The participants will undergo the following assessments: Pupil size measurement Manifest refraction (no autorefraction) Monocular in both eyes and binocular uncorrected visual acuity (photopic): Distance (4 m) Intermediate (80 cm) Near (40 cm) Monocular best corrected visual acuity (photopic): Distance (4 m) Near (40 cm) Distance-corrected near (40 cm) Monocular and binocular mesopic (with and without glare) and photopic (without glare) contrast sensitivity testing (subgroup) Slit lamp examination Tear breakup time Placido Corneal topography, keratometry and pachymetry Optical coherence tomography including epithelium mapping (subgroup) Applanation intraocular pressure Cycloplegic refraction Dilated fundus examination Wavefront aberrometry (subgroup) Adverse events

Locations
Country Name City State
Czechia Gemini - Ocní klinika Zlín Zlín
Ireland Wellington Eye Clinic Dublin
Turkey Medipol University Istanbul
United Kingdom Centre For Sight East Grinstead

Sponsors (1)
Lead Sponsor Collaborator
Allotex, Inc.

Countries where clinical trial is conducted

Czechia,  Ireland,  Turkey,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary An exploratory data collection project with no primary safety or effectiveness endpoints. An exploratory data collection project with no primary safety or effectiveness endpoints. 4 years or more after TCA implantation
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