NCT07208604

Open Label, Multi-center, Phase I Study of TECLens Quantitative Refractive Crosslinking in Presbyopia-Aged Patients.

Open Label, Multi-center, Phase I Study of TECLens Corneal Crosslinking System for Correction of Refractive Error in Patients of Presbyopia Age.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: TECLens, Inc. · Industry
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

An 'on-eye' UV delivery system for corneal crosslinking can be used safely and effectively to help free presbyopic patients from the need for reading glasses.

Detailed description

The clinical trial is evaluating the TECLens CXLens Crosslinking System, an investigational treatment using ultraviolet (UV) light (375 nm) with riboflavin (vitamin B2) to strengthen and reshape the cornea. By creating controlled biomechanical changes, this study aims to test whether the cornea can be reshaped to reduce refractive errors such as mild myopia or hyperopia in patients of presbyopic age.

Conditions

• Presbyopia

Interventions

Type	Name	Description
DEVICE	Quantitative refractive crosslinking	Non-invasive corneal cross-linking device delivering controlled UV light through a contact lens platform for biomechanical stabilization of the cornea.

Timeline

• Start date: 2025-09-30
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2025-10-06
• Last updated: 2025-10-06

Locations

1 site across 1 country: Philippines