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.
Study Type
OBSERVATIONAL
Enrollment
71
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
Gemini - Oční klinika Zlín
Zlín, Czechia
Wellington Eye Clinic
Dublin, Ireland
Medipol University
Istanbul, Turkey (Türkiye)
Centre For Sight
East Grinstead, United Kingdom
An exploratory data collection project with no primary safety or effectiveness endpoints.
An exploratory data collection project with no primary safety or effectiveness endpoints.
Time frame: 4 years or more after TCA implantation
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Eye Clinic London
London, United Kingdom
Centre For Sight
London, United Kingdom
Centre For Sight
Oxshott, United Kingdom