Clinical trial NCT03918408: Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking
Official title: Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-Linking in Eyes With Corneal Thinning Conditions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Keratoconus, Unstable
Bacterial Keratitis
Ectasia of Cornea
Lead sponsor: Pacific Clear Vision Institute
Sponsor class: OTHER
First posted: 2019-04-17
Enrollment: 300
Sex: ALL
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Treatment of patients with disease
Primary purpose: TREATMENT

Brief summary: To determine whether the Peschke PXL-330 system is safe and effective in the treatment of corneal thinning conditions.

Detailed description: Patients with progressive keratoconus, pellucid marginal degeneration, infectious keratitis, or at risk for post-refractive corneal ectasia will be recruited and undergo epithelial-on corneal crosslinking with the Peschke PXL-330 system using pulsed, accelerated energy delivery. Patients will undergo monitoring for 1 year, with serial measurements of corneal topography, visual acuity, intraocular pressure, and visual function questionnaire.

Eligibility criteria: 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

Primary outcomes:
measure: Mean keratometry in diopters
timeFrame: 12 months
Secondary outcomes:
measure: Best corrected visual acuity
timeFrame: 12 months
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Pacific Clear Vision Institute
state: Oregon
Study officials:
affiliation: PCVI
name: BALAMURALI AMBATI, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Caporossi A, Baiocchi S, Mazzotta C, Traversi C, Caporossi T. Parasurgical therapy for keratoconus by riboflavin-ultraviolet type A rays induced cross-linking of corneal collagen: preliminary refractive results in an Italian study. J Cataract Refract Surg. 2006 May;32(5):837-45. doi: 10.1016/j.jcrs.2006.01.091.
citation: Caporossi A, Mazzotta C, Baiocchi S, Caporossi T. Long-term results of riboflavin ultraviolet a corneal collagen cross-linking for keratoconus in Italy: the Siena eye cross study. Am J Ophthalmol. 2010 Apr;149(4):585-93. doi: 10.1016/j.ajo.2009.10.021. Epub 2010 Feb 6.
citation: Chatzis N, Hafezi F. Progression of keratoconus and efficacy of pediatric [corrected] corneal collagen cross-linking in children and adolescents. J Refract Surg. 2012 Nov;28(11):753-8. doi: 10.3928/1081597X-20121011-01.
citation: Mazzotta C, Traversi C, Caragiuli S, Rechichi M. Pulsed vs continuous light accelerated corneal collagen crosslinking: in vivo qualitative investigation by confocal microscopy and corneal OCT. Eye (Lond). 2014 Oct;28(10):1179-83. doi: 10.1038/eye.2014.163. Epub 2014 Jul 25.