Quantitative Refractive Crosslinking in Presbyopia Aged Patients
NCT ID: NCT07137767
Last Updated: 2025-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
25 participants
INTERVENTIONAL
2025-08-31
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Group
Epithelium-on Corneal Crosslinking
Quantitative refractive crosslinking
Non-invasive corneal crosslinking device delivering controlled UV light through a contact lens platform for refractive reshaping of the cornea.
Interventions
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Quantitative refractive crosslinking
Non-invasive corneal crosslinking device delivering controlled UV light through a contact lens platform for refractive reshaping of the cornea.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
65 Years
ALL
No
Sponsors
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Renato Ambrósio, MD - Rio Vision; Tijuca Rio de Janeiro, Brazil
UNKNOWN
Juan Batlle, Jr. MD - Laser Center; Santo Domingo, Dominican Rep.
UNKNOWN
TECLens, Inc.
INDUSTRY
Responsible Party
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Locations
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Rio Vision Hospital Oftalmológico
Rio de Janeiro, , Brazil
Laser Center
Santo Domingo, , Dominican Republic
Countries
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Central Contacts
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Facility Contacts
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Erica Rossi, 55-21-98391-1111
Role: backup
Other Identifiers
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TEC-007
Identifier Type: -
Identifier Source: org_study_id
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