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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07208604

Enrollment

Registered

2025-10-06

Start date

2025-09-30

Completion date

2026-08-31

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Presbyopia

Keywords

Corneal crosslinking, Presbyopia, Myopia, Hyperopia

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 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.

Interventions

DEVICEQuantitative refractive crosslinking

Non-invasive corneal cross-linking device delivering controlled UV light through a contact lens platform for biomechanical stabilization of the cornea.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Reduce refractive error	3-months post procedure	Achieve manifest refraction outcome at 3 months post treatment within 0.75D of the pre-planned targeted refraction, in patients aged 40 to 65 years old

Countries

Philippines

Contacts

Primary ContactPatrick Lopath

plopath@teclens.com919-824-5224

Backup ContactIbrahim Seven

ibrahim.seven@teclens.com440-485-9091

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026