No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
10 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
500 (estimated)
Sponsor
Goodman Eye Center · Other
Who this trial is looking for
This trial is looking for individuals aged 10 or older with conditions like keratoconus or corneal ectasia. If selected, I would undergo a treatment called corneal cross-linking using the PXL Platinum 330 system to help improve my eye condition.
Are You a Good Fit for This Trial?
You may be able to join if
I am 10 years old or older
I have been diagnosed with keratoconus or corneal ectasia
I have steepening or thinning in my cornea
I have specific signs related to keratoconus or corrosion
I have a steepest keratometry value of at least 47.20 D
I have a difference in keratometry of more than 1.5 D
I have a thinnest corneal point of more than 300 microns
You may not be able to join if
I have a normal cornea or atypical normal cornea
My cornea is thinner than 300 microns at the thinnest point
I have had certain corneal diseases or serious scars in my eye
I am pregnant or breastfeeding
I am allergic to the study medications
I have nystagmus or any condition preventing steady gaze
I have a current condition that affects healing after treatment
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
To evaluate the safety and effectiveness of the PXL Platinum 330 system for performing corneal cross-linking (CXL) for the treatment of ectatic disorders.
Trial Locations
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City
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Status
Eligibility Criteria
Inclusion Criteria:
Subjects who have one or both eyes that meet criteria 1 and 1 or more of the following criteria will be considered candidates for this study:
1.10 years of age or older 2. Presence of central or inferior steepening 3. Axial topography consistent with keratoconus, post-surgical …
Inclusion Criteria:
Subjects who have one or both eyes that meet criteria 1 and 1 or more of the following criteria will be considered candidates for this study:
1.10 years of age or older 2. Presence of central or inferior steepening 3. Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration 4. Presence of one or more findings associated with keratoconus or pellucid marginal degeneration, such as:
1. Fleischer ring
2. Vogt's striae
3. Decentered corneal apex
4. Munson's sign
5. Apical Corneal scarring consistent with Bowman's breaks
6. Scissoring of the retinoscopic reflex
7. Crab-claw appearance on topography 5. Steepest keratometry (Kmax) value ≥ 47.20 D 6. I-S keratometry difference \> 1.5 D on the Pentacam map or topography map 7. Posterior corneal elevation \>16 microns 8. Thinnest corneal point \>300 microns 9. Contact Lens Wearers Only:
a. Removal of contact lenses for the required period of time prior to the screening refraction: Contact Lens Type Minimum Discontinuation Time Soft or Scleral 3 days Rigid gas permeable 2 weeks
Exclusion Criteria:
All subjects meeting any of the following criteria will be excluded from this study:
1. Eyes classified as either normal or atypical normal on the severity grading scheme.
2. Corneal pachymetry at the screening exam that is \<300 microns at the thinnest point in the eye(s) to be treated.
3. Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example:
1. History of or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, acanthomeoeba, etc.)
2. 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.
4. Pregnancy (including plan to become pregnant) or lactation during the course of the study
5. A known sensitivity to study medications
6. Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests.
7. Patients with a current condition that, in the physician's opinion, would interfere with or prolong epithelial healing.
Contacts
No contact information available.
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