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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06310252

Enrollment

Registered

2024-03-15

Start date

2024-02-13

Completion date

2024-11-22

Last updated

2024-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Presbyopia

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.

Interventions

DIAGNOSTIC_TESTOpthalmic 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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

Inclusion criteria

* 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.

Exclusion criteria

• There are no known

Design outcomes

Primary

Measure	Time frame	Description
An exploratory data collection project with no primary safety or effectiveness endpoints.	4 years or more after TCA implantation	An exploratory data collection project with no primary safety or effectiveness endpoints.

Countries

Czechia, Ireland, Turkey (Türkiye), United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026