Quantitative Refractive Crosslinking in Presbyopia Aged Patients

NCT07137767 — Not applicable, Not yet recruiting, 25 participants, TECLens, Inc.

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Quantitative Refractive Crosslinking in Presbyopia-Aged Patients: An Open Label, Multi-center, Phase I Study of the TECLens Corneal Crosslinking System for Correction of Refractive Error in Patients of Presbyopia Age

Registry	NCT07137767
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	25 (Estimated)
Sponsor	TECLens, Inc. (Industry); collaborators: Renato Ambrósio, MD - Rio Vision; Tijuca Rio de Janeiro, Brazil, Juan Batlle, Jr. MD - Laser Center; Santo Domingo, Dominican Rep.
Conditions	Presbyopia
Interventions	Quantitative refractive crosslinking (Device)
Dates	start 2025-08-31 (estimated), primary completion 2026-08-01 (estimated), completion 2026-08-01 (estimated), first posted 2025-08-22, last updated 2025-08-29
Locations	2 sites in Brazil, Dominican Republic

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Treatment Group	Experimental	Device: Quantitative refractive crosslinking	Epithelium-on Corneal Crosslinking

Quantitative refractive crosslinking (Device): Non-invasive corneal crosslinking device delivering controlled UV light through a contact lens platform for refractive reshaping of the cornea.

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 40 Years to 65 Years

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

+Locations (2)

Facility	City	Country	Status
Rio Vision Hospital Oftalmológico	Rio de Janeiro	Brazil
Laser Center	Santo Domingo	Dominican Republic