Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking in Eyes With Corneal Ectasia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age10+
SponsorGoodman Eye Center
About this trial
To evaluate the safety and effectiveness of the PXL Platinum 330 system for performing corneal cross-linking (CXL) for the treatment of ectatic disorders.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Fleischer ring
Vogt's striae
Decentered corneal apex
Munson's sign
Disqualifiers
Eyes classified as either normal or atypical normal on the severity grading scheme.
Corneal pachymetry at the screening exam that is <300 microns at the thinnest point in the eye(s) to be treated.
History of or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, acanthomeoeba, etc.)
Clinically significant corneal scarring in the CXL treatment zone that is not related to keratoconus or, in the investigator's opinion, will interfere with the cross-linking procedure.
Trial design
Design model
Single group
Treatments tested in this trial
PXL-330 Platinum device for crosslinking with Peschke riboflavin solution
Combination productRiboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: Pulsed, acceleratedExperimental treatment 1 intervention
Group B: Pusled, acceleratedExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Best-contact corrected visual acuity (BSCVA)
Change in BSCVA compared to baseline.
Time frame
3, 6, and 12 monthsSecondary outcomes
1
Uncorrected visual acuity
Change in UCVA compared to baseline.
Time frame
3, 6, and 12 months2
Keratometry
Change in Kmax, compared to baseline.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov