Cornea Ectasia, Keratoconus
Conditions
Brief summary
To evaluate the safety and effectiveness of the PXL Platinum 330 device for performing Corneal Crosslinking in patients with corneal thinning conditions.
Detailed description
Patients with progressive keratoconus, pellucid marginal degeneration, 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 assessments.
Interventions
COMBINATION_PRODUCTEpithelial-on Corneal Crosslinking with the PXL 330 Platinum system.
PXL-330 Platinum device for crosslinking with Peschke riboflavin solution. Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea.
Sponsors
Arbor Center for Eye Care
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Randomized at outset
Intervention model description
Treatment of patients with disease
Eligibility
Sex/Gender
ALL
Age
12 Years to 60 Years
Healthy volunteers
No
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: 1. 12 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. Rizzutti's sign 6. Apical Corneal scarring consistent with Bowman's breaks 7. Scissoring of the retinoscopic reflex 8. 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 7. Posterior corneal elevation \>16 microns 8. Thinnest corneal point \<485 microns 9. Predicted Post LASIK/PRK stromal ablation depth \<350 microns or expected keratometry \>47.2 D, or patients undergoing PRK in keratoconus suspect eyes 10. Contact Lens Wearers Only: a. Removal of contact lenses for the required period of time prior to the screening refraction: 11. Signed written informed consent 12. Willingness and ability to comply with schedule for follow-up visits 13. 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): 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, 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. 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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Keratometry in Diopters | 1 year | Average keratometry across the anterior topography of the cornea computed by a validated topographer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pulsed, Accelerated Following riboflavin instillation, the eye was exposed to UVA pulsed light at 18mW/cm2 for 5 seconds, followed by 5 seconds off, repeating over 10 minutes of illumination.
Epithelial-on Corneal Crosslinking with the PXL 330 Platinum system.: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution.
Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea. | 7 |
| Pulsed, Accelerated Following riboflavin instillation, the eye was exposed to UVA pulsed light at 18mW/cm2 for 5 seconds, followed by 5 seconds off, repeating over 10 minutes of illumination.
Epithelial-on Corneal Crosslinking with the PXL 330 Platinum system.: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution.
Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea. | 13 |
| Conventional Following riboflavin instillation, the eye was exposed to UVA continuous light at 9mW/cm2 for 10 minutes
Epithelial-on Corneal Crosslinking with the PXL 330 Platinum system.: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution.
Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea. | 4 |
| Conventional Following riboflavin instillation, the eye was exposed to UVA continuous light at 9mW/cm2 for 10 minutes
Epithelial-on Corneal Crosslinking with the PXL 330 Platinum system.: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution.
Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea. | 4 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 1 |
Baseline characteristics
| Characteristic | Conventional | Total | Pulsed, Accelerated |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Eyes | 4 Eyes | 4 Eyes |
| Age, Categorical >=65 years | 0 Eyes | 0 Eyes | 0 Eyes |
| Age, Categorical Between 18 and 65 years | 4 Eyes | 13 Eyes | 9 Eyes |
| Age, Continuous | 36.8 years STANDARD_DEVIATION 13.2 | 31.2 years STANDARD_DEVIATION 11.6 | 29.4 years STANDARD_DEVIATION 11.1 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 4 participants | 11 participants | 7 participants |
| Sex: Female, Male Female | 2 Eyes | 12 Eyes | 10 Eyes |
| Sex: Female, Male Male | 2 Eyes | 5 Eyes | 3 Eyes |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 4 |
| other Total, other adverse events | 1 / 7 | 0 / 4 |
| serious Total, serious adverse events | 0 / 7 | 0 / 4 |
Outcome results
Primary
Mean Keratometry in Diopters
Average keratometry across the anterior topography of the cornea computed by a validated topographer
Time frame: 1 year
Population: The study was conducted during the COVID-19 pandemic. Some patients were unable or felt uncomfortable presenting to a physician's office for follow-up measurements. These individuals are marked as lost to follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pulsed, Accelerated | Mean Keratometry in Diopters | Screening | 51.0 Diopters | Standard Deviation 9.9 |
| Pulsed, Accelerated | Mean Keratometry in Diopters | 3 months | 50.3 Diopters | Standard Deviation 7.8 |
| Pulsed, Accelerated | Mean Keratometry in Diopters | 6 months | 46.6 Diopters | Standard Deviation 0.9 |
| Pulsed, Accelerated | Mean Keratometry in Diopters | 12 months | 47.9 Diopters | Standard Deviation 11.3 |
| Conventional | Mean Keratometry in Diopters | 12 months | 45.8 Diopters | Standard Deviation 4.6 |
| Conventional | Mean Keratometry in Diopters | Screening | 49.8 Diopters | Standard Deviation 4.8 |
| Conventional | Mean Keratometry in Diopters | 6 months | 49.1 Diopters | Standard Deviation 5.5 |
| Conventional | Mean Keratometry in Diopters | 3 months | 49.0 Diopters | Standard Deviation 5.6 |
Secondary
Best Corrected Visual Acuity With Spectacles or Contact Lenses
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.
Time frame: 1 year
Population: Patients recruited at a single center based on physician examination for corneal ectasia in one or both eyes. The first patient was screened for enrollment in June 2020, while the last patient was screened in October 2021.
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| Pulsed, Accelerated | Best Corrected Visual Acuity With Spectacles or Contact Lenses | Screening | 20/25 or better | 0 Eyes |
| Pulsed, Accelerated | Best Corrected Visual Acuity With Spectacles or Contact Lenses | Screening | 20/30 - 20/50 | 0 Eyes |
| Pulsed, Accelerated | Best Corrected Visual Acuity With Spectacles or Contact Lenses | Screening | 20/60 - 20/200 | 8 Eyes |
| Pulsed, Accelerated | Best Corrected Visual Acuity With Spectacles or Contact Lenses | Screening | Worse than 20/200 | 5 Eyes |
| Pulsed, Accelerated | Best Corrected Visual Acuity With Spectacles or Contact Lenses | 1 month post-procedure | 20/25 or better | 0 Eyes |
| Pulsed, Accelerated | Best Corrected Visual Acuity With Spectacles or Contact Lenses | 1 month post-procedure | 20/30 - 20/50 | 6 Eyes |
| Pulsed, Accelerated | Best Corrected Visual Acuity With Spectacles or Contact Lenses | 1 month post-procedure | 20/60 - 20/200 | 2 Eyes |
| Pulsed, Accelerated | Best Corrected Visual Acuity With Spectacles or Contact Lenses | 1 month post-procedure | Worse than 20/200 | 0 Eyes |
| Pulsed, Accelerated | Best Corrected Visual Acuity With Spectacles or Contact Lenses | 3 months post- procedure | 20/25 or better | 1 Eyes |
| Pulsed, Accelerated | Best Corrected Visual Acuity With Spectacles or Contact Lenses | 3 months post- procedure | 20/30 - 20/50 | 6 Eyes |
| Pulsed, Accelerated | Best Corrected Visual Acuity With Spectacles or Contact Lenses | 3 months post- procedure | 20/60 - 20/200 | 1 Eyes |
| Pulsed, Accelerated | Best Corrected Visual Acuity With Spectacles or Contact Lenses | 3 months post- procedure | Worse than 20/200 | 1 Eyes |
| Pulsed, Accelerated | Best Corrected Visual Acuity With Spectacles or Contact Lenses | 6 months post-procedure | 20/25 or better | 1 Eyes |
| Pulsed, Accelerated | Best Corrected Visual Acuity With Spectacles or Contact Lenses | 6 months post-procedure | 20/30 - 20/50 | 5 Eyes |
| Pulsed, Accelerated | Best Corrected Visual Acuity With Spectacles or Contact Lenses | 6 months post-procedure | 20/60 - 20/200 | 0 Eyes |
| Pulsed, Accelerated | Best Corrected Visual Acuity With Spectacles or Contact Lenses | 6 months post-procedure | Worse than 20/200 | 0 Eyes |
| Pulsed, Accelerated | Best Corrected Visual Acuity With Spectacles or Contact Lenses | 12 months post-procedure | 20/25 or better | 1 Eyes |
| Pulsed, Accelerated | Best Corrected Visual Acuity With Spectacles or Contact Lenses | 12 months post-procedure | 20/30 - 20/50 | 1 Eyes |
| Pulsed, Accelerated | Best Corrected Visual Acuity With Spectacles or Contact Lenses | 12 months post-procedure | 20/60 - 20/200 | 0 Eyes |
| Pulsed, Accelerated | Best Corrected Visual Acuity With Spectacles or Contact Lenses | 12 months post-procedure | Worse than 20/200 | 0 Eyes |
| Conventional | Best Corrected Visual Acuity With Spectacles or Contact Lenses | 12 months post-procedure | 20/30 - 20/50 | 1 Eyes |
| Conventional | Best Corrected Visual Acuity With Spectacles or Contact Lenses | Screening | 20/25 or better | 0 Eyes |
| Conventional | Best Corrected Visual Acuity With Spectacles or Contact Lenses | 3 months post- procedure | 20/60 - 20/200 | 0 Eyes |
| Conventional | Best Corrected Visual Acuity With Spectacles or Contact Lenses | Screening | 20/30 - 20/50 | 1 Eyes |
| Conventional | Best Corrected Visual Acuity With Spectacles or Contact Lenses | 6 months post-procedure | Worse than 20/200 | 0 Eyes |
| Conventional | Best Corrected Visual Acuity With Spectacles or Contact Lenses | Screening | 20/60 - 20/200 | 2 Eyes |
| Conventional | Best Corrected Visual Acuity With Spectacles or Contact Lenses | 3 months post- procedure | Worse than 20/200 | 0 Eyes |
| Conventional | Best Corrected Visual Acuity With Spectacles or Contact Lenses | Screening | Worse than 20/200 | 1 Eyes |
| Conventional | Best Corrected Visual Acuity With Spectacles or Contact Lenses | 12 months post-procedure | Worse than 20/200 | 0 Eyes |
| Conventional | Best Corrected Visual Acuity With Spectacles or Contact Lenses | 1 month post-procedure | 20/25 or better | 1 Eyes |
| Conventional | Best Corrected Visual Acuity With Spectacles or Contact Lenses | 6 months post-procedure | 20/25 or better | 1 Eyes |
| Conventional | Best Corrected Visual Acuity With Spectacles or Contact Lenses | 1 month post-procedure | 20/30 - 20/50 | 1 Eyes |
| Conventional | Best Corrected Visual Acuity With Spectacles or Contact Lenses | 12 months post-procedure | 20/25 or better | 1 Eyes |
| Conventional | Best Corrected Visual Acuity With Spectacles or Contact Lenses | 1 month post-procedure | 20/60 - 20/200 | 1 Eyes |
| Conventional | Best Corrected Visual Acuity With Spectacles or Contact Lenses | 6 months post-procedure | 20/30 - 20/50 | 1 Eyes |
| Conventional | Best Corrected Visual Acuity With Spectacles or Contact Lenses | 1 month post-procedure | Worse than 20/200 | 0 Eyes |
| Conventional | Best Corrected Visual Acuity With Spectacles or Contact Lenses | 12 months post-procedure | 20/60 - 20/200 | 1 Eyes |
| Conventional | Best Corrected Visual Acuity With Spectacles or Contact Lenses | 3 months post- procedure | 20/25 or better | 1 Eyes |
| Conventional | Best Corrected Visual Acuity With Spectacles or Contact Lenses | 6 months post-procedure | 20/60 - 20/200 | 1 Eyes |
| Conventional | Best Corrected Visual Acuity With Spectacles or Contact Lenses | 3 months post- procedure | 20/30 - 20/50 | 2 Eyes |