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 volunteersQualifiers
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
DeviceNon-invasive corneal crosslinking device delivering controlled UV light through a contact lens platform for refractive reshaping of the cornea.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup 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 procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
TECLens, Inc.
Lead sponsor
Renato Ambrósio, MD - Rio Vision; Tijuca Rio de Janeiro, Brazil
Collaborator
Juan Batlle, Jr. MD - Laser Center; Santo Domingo, Dominican Rep.
Collaborator
Source ClinicalTrials.gov
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