Quantitative Refractive Crosslinking in Presbyopia Aged Patients

NCT ID: NCT07137767

Last Updated: 2025-08-29

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2026-08-31

Brief Summary

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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

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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.

Conditions

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Presbyopia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Group

Epithelium-on Corneal Crosslinking

Group Type EXPERIMENTAL

Quantitative refractive crosslinking

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Renato Ambrósio, MD - Rio Vision; Tijuca Rio de Janeiro, Brazil

UNKNOWN

Sponsor Role collaborator

Juan Batlle, Jr. MD - Laser Center; Santo Domingo, Dominican Rep.

UNKNOWN

Sponsor Role collaborator

TECLens, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rio Vision Hospital Oftalmológico

Rio de Janeiro, , Brazil

Site Status

Laser Center

Santo Domingo, , Dominican Republic

Site Status

Countries

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Brazil Dominican Republic

Central Contacts

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Patrick Lopath

Role: CONTACT

919-824-5224

Ibrahim Seven

Role: CONTACT

440-485-9091

Facility Contacts

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Monica Pinto

Role: primary

55-21-9856-81649

Erica Rossi, 55-21-98391-1111

Role: backup

Maria C Varela

Role: primary

809-593-1324 ext. 1350

Other Identifiers

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TEC-007

Identifier Type: -

Identifier Source: org_study_id

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