Corneal Crosslinking for Treatment of Progressive Keratoconus or Corneal Ectasia
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age10-90
SponsorPrice Vision Group
About this trial
This randomized study compares 2 variations of corneal crosslinking for treatment of keratoconus or corneal ectasia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of keratoconus or corneal ectasia
Provision of written informed consent
Disqualifiers
Previous ocular condition in the study eye that may predispose for future complications including history of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.)
Clinically significant corneal scarring in the proposed treatment zone
History of chemical injury or delayed epithelial healing in the study eye
Known sensitivity to study medication
Trial design
Design model
Parallel
Treatments tested in this trial
Riboflavin 0.1% ophthalmic solution and pulsed light
Combination productUse of riboflavin 0.1% eye drops and pulsed 18 milliwatt/cm2 ultraviolet A light for 10 minutes
Riboflavin 0.1% ophthalmic solution and non-pulsed light
Combination productUse of riboflavin 0.1% eye drops and non-pulsed 9 milliwatt/cm2 ultraviolet A light for 10 minutes
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: PulsedActive comparator 1 intervention
Group B: Non-pulsedActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in maximum keratometry
assessed with corneal tomography
Time frame
6 monthsSecondary outcomes
1
change in corrected distance visual acuity
assessed with Snellen chart
Time frame
6 months2
change in uncorrected distance visual acuity
assessed with Snellen chart
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov