NCT03918408 · Pacific Clear Vision Institute
Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking
What this study is about
To determine whether the Peschke PXL-330 system is safe and effective in the treatment of corneal thinning conditions.
View original scientific description
To determine whether the Peschke PXL-330 system is safe and effective in the treatment of corneal thinning conditions.
Interventions
COMBINATION_PRODUCT
PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution
Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea
Primary outcome measures
Mean keratometry in diopters
Time frame: 12 months
Average keratometry across the anterior topography of the cornea computed by a validated Scheimpflug topographer
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subjects who have one or both eyes that meet criteria 1 \& 2 and 1 or more of the following criteria will be considered candidates for this study.
- 12 years of age or older
- Evidence of progressive keratoconus (based on the discretion of the physician as evidenced by an increase in astigmatism, asymmetry, or worsening vision in the last 3 or more months)
- Presence of central or inferior steepening.
- Axial topography consistent with keratoconus
- Presence of one or more findings associated with keratoconus such as:
- Fleischer ring
- Vogt's striae
- Decentered corneal apex
- Munson's sign
- Rizzutti's sign
- Apical Corneal scarring consistent with Bowman's breaks
- Scissoring of the retinoscopic reflex
- Crab-claw appearance on topography
- Steepest keratometry (Kmax) value ≥ 47.20 D
- I-S keratometry difference \> 1.5 D on the Pentacam/Galilei/Orbscan/Cassini map or topography map
- Posterior corneal elevation \>16 microns
- Thinnest corneal point \<485 microns
- AvaGen (Avellino Labs) genetic testing keratoconus risk score of 67 or higher (high risk).
- Signed written informed consent
- Willingness and ability to comply with schedule for follow-up visits
- For Contact Lens Wearers Only: Removal of contact lenses for the required period of time prior to the screening refraction:
- Contact Lens Type Minimum Discontinuation Time:
- Soft: 1 Week
- Soft Extended Wear: 2 Weeks
- Soft Toric: 3 Weeks
- Rigid gas permeable: 2 Weeks per decade of wear
- Scleral Lenses
- Investigator Discretion \[Discontinuation of scleral lenses not required unless there is clinical evidence of corneal hypoxia (e.g. corneal neovascularization) at time of screening\]
- Signed written informed consent
- Willingness and ability to comply with schedule for follow-up visits
Exclusion criteria
- (any of the following are reasons for exclusion):
- Eyes classified as either normal or atypical normal on the severity grading scheme.
- Corneal pachymetry at the screening exam that is \<330 microns at the thinnest point in the eye(s) to be treated.
- Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example:
- 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.
- Pregnancy (including plan to become pregnant) or lactation during the course of the study
- A known sensitivity to study medications
- Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests.
- Patients with active medical implants (e.g. cardiac pacemakers)'
- Patients who are aphakic/ pseudophakic
Where
- Eugene, Oregon
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 12, 2024 · Source of record for eligibility and locations