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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 71 (actual)
• Sponsor: Allotex, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Opthalmic assessments	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

Timeline

• Start date: 2024-02-13
• Primary completion: 2024-11-22
• Completion: 2024-11-22
• First posted: 2024-03-15
• Last updated: 2024-12-19

Locations

7 sites across 4 countries: Czechia, Ireland, Turkey (Türkiye), United Kingdom