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

NCT06310252 | Completed

• 1 other identifier: PRO_010-2023
• Study Type: observational
• Target: 71
• Locations: 4 countries
• Sites: 7

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.

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Opthalmic assessments DIAGNOSTIC_TEST

The participants will undergo the following assessments: 1. Pupil size measurement 2. Manifest refraction (no autorefraction) 3. Monocular in both eyes and binocular uncorrected visual acuity (photopic): * Distance (4 m) * Intermediate (80 cm) * Near (40 cm) 4. Monocular best corrected visual acuity (photopic): * Distance (4 m) * Near (40 cm) * Distance-corrected near (40 cm) 5. Monocular and binocular mesopic (with and without glare) and photopic (without glare) contrast sensitivity testing (subgroup) 6. Slit lamp examination 7. Tear breakup time 8. Placido Corneal topography, keratometry and pachymetry 9. Optical coherence tomography including epithelium mapping (subgroup) 10. Applanation intraocular pressure 11. Cycloplegic refraction 12. Dilated fundus examination 13. Wavefront aberrometry (subgroup) 14. Adverse events

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A maximum of 101 eyes of qualified and consented subjects will undergo long term follow-up after instrastromal implantation of the TCA for presbyopia.

You may qualify if:

• 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.

Sponsors & Collaborators

• Allotex, Inc.: lead

Study Sites (7)

Gemini - Oční klinika Zlín

Zlín, 760 01, Czechia

Location

Wellington Eye Clinic

Dublin, D18 T8P3, Ireland

Location

Medipol University

Istanbul, 34214, Turkey (Türkiye)

Location

Centre For Sight

East Grinstead, RH19 4RH, United Kingdom

Location

Eye Clinic London

London, W1G 8GQ, United Kingdom

Location

Centre For Sight

London, W1G 9LG, United Kingdom

Location

Centre For Sight

Oxshott, KT22 0JR, United Kingdom

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 15, 2024
• Study Start: February 13, 2024
• Primary Completion: November 22, 2024
• Study Completion: November 22, 2024
• Last Updated: December 19, 2024

Record last verified: 2024-12

Locations

TU (1); CZ (1); IE (1); GB (4)