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OpenTrials
Completed

NCT Number: NCT06310252

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

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.

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Key information

Conditions

Presbyopia Eye Diseases Refractive Errors

Sex eligibility

All sexes

Study type

Observational

Primary location

Gemini - Oční klinika Zlín, Zlín, Czechia

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Opthalmic assessments

Diagnostic Test

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

Primary outcomes

  1. An exploratory data collection project with no primary safety or effectiveness endpoints.

    Time frame: 4 years or more after TCA implantation

    An exploratory data collection project with no primary safety or effectiveness endpoints.

Sponsors and collaborators

Lead sponsor

Allotex, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 15, 2024
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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