BridgeMD
Tests treatment safety and results for Keratoconus, Unstable
Official title Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking
ClinicalTrials.gov ID: NCT03918408
What this study is testing
What is PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution?
PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution is an investigational medicine, being studied as a potential treatment for keratoconus, unstable.
Also referred to as Corneal crosslinking.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To determine whether the Peschke PXL-330 system is safe and effective in the treatment of corneal thinning conditions.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 45
You may be able to join if
- people 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...
- Presence of central or inferior steepening.
- Axial topography consistent with keratoconus
You likely can't join if
- (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...
See the full eligibility criteria
- people 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
- (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
The study team makes the final eligibility decision.
Where it's taking place
- Eugene, Oregon, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Eugene, Oregon, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.