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

TECLens, Inc.

Status

Begins enrollment this month

Conditions

Presbyopia

Treatments

Device: Quantitative refractive crosslinking

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT07137767

TEC-007

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 estimated patients

Sex

All

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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