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Open Label, Multi-center, Phase I Study of TECLens Quantitative Refractive Crosslinking in Presbyopia-Aged Patients.

ConditionPresbyopia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-65
SponsorTECLens, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Corneal dystrophy, scarring, or prior corneal crosslinking

Astigmatism >1.0 D

Active ocular infection, inflammation, or uncontrolled dry eye

Advanced glaucoma or diabetic retinopathy

Trial design

Design model

Single group

Treatments tested in this trial

  • Quantitative refractive crosslinking

    Device

    Non-invasive corneal cross-linking device delivering controlled UV light through a contact lens platform for biomechanical stabilization of the cornea.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Treatment GroupExperimental treatment 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

TECLens, Inc.

Lead sponsor

Robert Ang, MD

Collaborator

Robert Ang, MD - Asian Eye Institute

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: