ClinicalTrials.gg
Not yet recruitingNCT07137767Updated Aug 29, 2025

Quantitative Refractive Crosslinking in Presbyopia Aged Patients

An interventional study of Quantitative refractive crosslinking in Presbyopia, sponsored by TECLens, Inc.. Not yet recruiting at 2 sites in 2 countries. Open to participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-08-29.

Sponsored by TECLens, Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2026, 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
40 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Presbyopia

Keywords

  • Corneal crosslinking
  • Presbyopia
  • Myopia
  • Hyperopia
03

In context

Presbyopia

336 studies on the registry are indexed under Presbyopia; 35 are open to participants now.

This study's planned enrollment of 25 is below the median of 61 across 276 interventional studies indexed under Presbyopia.

Browse Presbyopia studies →

Lead sponsor

TECLens, Inc. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 drug/device studies (within 30 days)
  • Patients with uncontrolled dry eye or surface disease
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    Treatment Group

    Epithelium-on Corneal Crosslinking

    Device: Quantitative refractive crosslinking

Interventions

  • DeviceQuantitative refractive crosslinking

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

06

What researchers measure

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

    Time frame: 3-months post procedure

07

Study locations

2 sites
  • Rio Vision Hospital Oftalmológico
    Rio de Janeiro, Brazil
    • Monica Pinto · ContactMonicacrispinto15@gmail.com · 55-21-9856-81649
    • Erica Rossi, 55-21-98391-1111 · Contact
    • Renato Ambrósio · Principal investigator
  • Laser Center
    Santo Domingo, Dominican Republic
    • Maria C Varela · Contactoftalmed@claro.net.do · 809-593-1324
    • Juan Batlle, Jr. · Principal investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2025; primary completion for Aug 2026, 12 months later.

Of 87 industry-sponsored interventional studies with no phase under Presbyopia, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 19. This study's planned 12 months is above that.

Counting every sponsor, half of 129 studies reached it within 10 months; a quarter within 3 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 15, 2025
First posted
Aug 22, 2025
StartEst.
Aug 31, 2025
Primary completionEst.
Aug 2026
CompletionEst.
Aug 2026
Last update
Aug 29, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07137767
Lead sponsor
TECLens, Inc.
Collaborators
Renato Ambrósio, MD - Rio Vision; Tijuca Rio de Janeiro, Brazil, Juan Batlle, Jr. MD - Laser Center; Santo Domingo, Dominican Rep.
Responsible party
Sponsor
First posted
Aug 22, 2025
Start date
Aug 31, 2025 (estimated)
Primary completion
Aug 2026 (estimated)
Completion
Aug 2026 (estimated)
Last update
Aug 29, 2025

Study contacts

Patrick Lopath
Contact
plopath@teclens.com
919-824-5224
Ibrahim Seven
Contact
ibrahim.seven@teclens.com
440-485-9091

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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