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

CompletedOBSERVATIONAL
Enrollment

71

Participants

Timeline

Start Date

February 13, 2024

Primary Completion Date

November 22, 2024

Study Completion Date

November 22, 2024

Conditions
Presbyopia
Interventions
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"

Trial Locations (7)

34214

Medipol University, Istanbul

760 01

Gemini - Oční klinika Zlín, Zlín

D18 T8P3

Wellington Eye Clinic, Dublin

RH19 4RH

Centre For Sight, East Grinstead

W1G 8GQ

Eye Clinic London, London

W1G 9LG

Centre For Sight, London

KT22 0JR

Centre For Sight, Oxshott

All Listed Sponsors
lead

Allotex, Inc.

INDUSTRY

NCT06310252 - Safety and Efficacy of an Intrastromal Transform Corneal Allograft (TCA) for Presbyopia Correction - Long Term Follow-up | Biotech Hunter | Biotech Hunter