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

NCT06310252 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 71

Last updated 2024-12-19

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Allotex, Inc.

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-13
Primary Completion
2024-11-22
Completion
2024-11-22

Countries

  • Czechia
  • Ireland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06310252 on ClinicalTrials.gov