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NCT Number: NCT07137767

Quantitative Refractive Crosslinking in Presbyopia Aged Patients

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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Key information

Conditions

Presbyopia Eye Diseases Hyperopia Myopia Refractive Errors

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rio Vision Hospital Oftalmológico, Rio de Janeiro, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quantitative refractive crosslinking

Device

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

Primary outcomes

  1. Reduce refractive error

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ibrahim Seven

CONTACT

[email protected]

440-485-9091

Patrick Lopath

CONTACT

[email protected]

919-824-5224

Sponsors and collaborators

Lead sponsor

TECLens, Inc.

Industry

Collaborators

  • Juan Batlle, Jr. MD - Laser Center; Santo Domingo, Dominican Rep.
  • Renato Ambrósio, MD - Rio Vision; Tijuca Rio de Janeiro, Brazil

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 22, 2025
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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