Status:
NOT_YET_RECRUITING
Open Label, Multi-center, Phase I Study of TECLens Quantitative Refractive Crosslinking in Presbyopia-Aged Patients.
Lead Sponsor:
TECLens, Inc.
Collaborating Sponsors:
Robert Ang, MD
Robert Ang, MD - Asian Eye Institute
Conditions:
Presbyopia
Eligibility:
All Genders
40-65 years
Phase:
NA
Brief 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 c...
Eligibility Criteria
Inclusion
- Adults aged 40-65 years
- Healthy cornea
- Refractive error between +4.0 D and -5.0 D
- Phakic or monofocal pseudophakic (≥6 months post IOL placement)
- Visual acuity correctable by ±0.25 D
Exclusion
- Corneal dystrophy, scarring, or prior corneal crosslinking
- Astigmatism \>1.0 D
- Active ocular infection, inflammation, or uncontrolled dry eye
- Advanced glaucoma or diabetic retinopathy
- History of delayed corneal healing
- Pregnancy, breastfeeding, or planning pregnancy during study period
- Certain medications (e.g., isotretinoin)
- Recent participation in other investigational drug/device studies (within 30 days)
- Patients with uncontrolled dry eye or surface disease
Key Trial Info
Start Date :
September 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT07208604
Start Date
September 30 2025
End Date
August 1 2026
Last Update
October 6 2025
Active Locations (1)
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1
Asian Eye Institute
Makati City, Philippines, Philippines