Quantitative Refractive Crosslinking in Presbyopia Aged Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Quantitative refractive crosslinking.
- Who it may be relevant to
- Registry conditions: Presbyopia. Basic parameters: 40 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil, Dominican Republic
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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
- Device Quantitative refractive crosslinking
Non-invasive corneal crosslinking device delivering controlled UV light through a contact lens platform for refractive reshaping of the cornea.
Primary outcome measures
- Reduce refractive error [Time frame: 3-months post procedure]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- Rio Vision Hospital Oftalmológico — Rio de Janeiro
Dominican Republic · 1 center
- Laser Center — Santo Domingo
Identifiers
NCT: NCT07137767 · TEC-007