NCT07137767

Brief 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.

Trial Health

67
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Aug 2025

Geographic Reach
2 countries

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Aug 2025Aug 2026

First Submitted

Initial submission to the registry

August 15, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 22, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

August 31, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

11 months

First QC Date

August 15, 2025

Last Update Submit

August 22, 2025

Conditions

Presbyopia

Keywords

Corneal crosslinkingPresbyopiaMyopiaHyperopia

Outcome Measures

Primary Outcomes (1)

  • Reduce refractive error

    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

    3-months post procedure

Study Arms (1)

Treatment Group

EXPERIMENTAL

Epithelium-on Corneal Crosslinking

Device: Quantitative refractive crosslinking

Interventions

Quantitative refractive crosslinkingDEVICE

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

Treatment Group

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rio Vision Hospital Oftalmológico

Rio de Janeiro, Brazil

Location

Laser Center

Santo Domingo, Dominican Republic

Location

MeSH Terms

Conditions

PresbyopiaMyopiaHyperopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Central Study Contacts

Patrick Lopath

CONTACT

919-824-5224plopath@teclens.com

Ibrahim Seven

CONTACT

440-485-9091ibrahim.seven@teclens.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2025

First Posted

August 22, 2025

Study Start

August 31, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

August 29, 2025

Record last verified: 2025-08

Locations

BR(1)DO(1)