Safety and Efficacy of an Intrastromal Transform Corneal... | NCT06310252 | Trialant

Safety and Efficacy of an Intrastromal Transform Corneal... | NCT06310252 | Trialant

Arms/Interventions Module

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Contacts/Locations Module