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

Presbyopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06310252
• Other study ID #: PRO_010-2023
• Status: Recruiting
• Start date: February 13, 2024
• Est. completion date: September 2024

Study information

• Verified date: June 2024
• Source: Allotex, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 101
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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 exclusion criteria.

Related Conditions & MeSH terms

• Presbyopia

Intervention

Diagnostic Test:
• Opthalmic assessments
The participants will undergo the following assessments: Pupil size measurement Manifest refraction (no autorefraction) Monocular in both eyes and binocular uncorrected visual acuity (photopic): Distance (4 m) Intermediate (80 cm) Near (40 cm) Monocular best corrected visual acuity (photopic): Distance (4 m) Near (40 cm) Distance-corrected near (40 cm) Monocular and binocular mesopic (with and without glare) and photopic (without glare) contrast sensitivity testing (subgroup) Slit lamp examination Tear breakup time Placido Corneal topography, keratometry and pachymetry Optical coherence tomography including epithelium mapping (subgroup) Applanation intraocular pressure Cycloplegic refraction Dilated fundus examination Wavefront aberrometry (subgroup) Adverse events

Locations

Country	Name	City	State
Czechia	Gemini - Ocní klinika Zlín	Zlín
Ireland	Wellington Eye Clinic	Dublin
Turkey	Medipol University	Istanbul
United Kingdom	Centre For Sight	East Grinstead
United Kingdom	Centre For Sight	London
United Kingdom	Eye Clinic London	London
United Kingdom	Centre For Sight	Oxshott

Sponsors (1)

Lead Sponsor	Collaborator
Allotex, Inc.

Countries where clinical trial is conducted

Czechia,  Ireland,  Turkey,  United Kingdom, 

Outcome

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