Safety and Efficacy of Corneal Crosslinking Using the PXL-Platinum 330 for Eyes With Corneal Ectatic Conditions

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 11

Inclusion Criteria

Inclusion Criteria: Criterion 1,2,3 are required for all participants. Participants must also meet one or more of criteria 4-12 . Criterion 13 is relevant only for contact lens wearers

Subjects who have one or both eyes that meet criteria 1 and one or more of the following criteria will be considered candidates for this study:

12 years of age or older
Presence of central or inferior steepening.
Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration
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. Rizzutti's sign
6. Apical Corneal scarring consistent with Bowman's breaks
7. Scissoring of the retinoscopic reflex
8. Crab-claw appearance on topography
Steepest keratometry (Kmax) value ≥ 47.20 D
I-S keratometry difference > 1.5 D on the Pentacam map
Posterior corneal elevation >16 microns
Thinnest corneal point <485 microns
Predicted Post LASIK/PRK stromal ablation depth <350 microns or expected keratometry >47.2 D, or patients undergoing PRK in keratoconus suspect eyes
Contact Lens Wearers Only:

a. Removal of contact lenses for the required period of time prior to the screening refraction:
Signed written informed consent
Willingness and ability to comply with schedule for follow-up visits
Contact Lens Wearers Only:
1. 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

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 <300 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:
1. History of or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, acanthamoeba, 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.
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 a current condition that, in the physician's opinion, would interfere with or prolong epithelial healing

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Pulsed, accelerated	Epithelial-on Corneal Crosslinking with the PXL 330 Platinum system.	18mW, 5 seconds on, 5 seconds off, 10 minutes of illumination.
Conventional	Epithelial-on Corneal Crosslinking with the PXL 330 Platinum system.	9mW continuous, 10 minutes of illumination.

Primary Outcome Measures

Name	Time	Method
Mean Keratometry in Diopters	1 year	Average keratometry across the anterior topography of the cornea computed by a validated topographer

Secondary Outcome Measures

Name	Time	Method
Best Corrected Visual Acuity With Spectacles or Contact Lenses	1 year	Measurement of best corrected visual acuity on the validated early-treatment diabetic retinopathy study scale. Snellen chart was used. Values closer to 20/20 indicate better vision.