Trial Outcomes & Findings for Safety and Efficacy of Corneal Crosslinking Using the PXL-Platinum 330 for Eyes With Corneal Ectatic Conditions (NCT NCT04240457)
NCT ID: NCT04240457
Last Updated: 2024-12-12
Results Overview
Average keratometry across the anterior topography of the cornea computed by a validated topographer
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
1 year
Results posted on
2024-12-12
Participant Flow
Unit of analysis: Eyes
Participant milestones
| Measure |
Pulsed, Accelerated
18mW, 5 seconds on, 5 seconds off, 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.
|
Conventional
9mW continuous, 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.
|
|---|---|---|
|
Overall Study
STARTED
|
7 13
|
4 4
|
|
Overall Study
COMPLETED
|
2 4
|
3 3
|
|
Overall Study
NOT COMPLETED
|
5 9
|
1 1
|
Reasons for withdrawal
| Measure |
Pulsed, Accelerated
18mW, 5 seconds on, 5 seconds off, 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.
|
Conventional
9mW continuous, 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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Pulsed, Accelerated
n=13 Eyes
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.
|
Conventional
n=4 Eyes
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.
|
Total
n=17 Eyes
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
3 Eyes
n=13 Eyes
|
2 Eyes
n=4 Eyes
|
5 Eyes
n=17 Eyes
|
|
Age, Categorical
<=18 years
|
4 Eyes
n=13 Eyes
|
0 Eyes
n=4 Eyes
|
4 Eyes
n=17 Eyes
|
|
Age, Categorical
Between 18 and 65 years
|
9 Eyes
n=13 Eyes
|
4 Eyes
n=4 Eyes
|
13 Eyes
n=17 Eyes
|
|
Age, Categorical
>=65 years
|
0 Eyes
n=13 Eyes
|
0 Eyes
n=4 Eyes
|
0 Eyes
n=17 Eyes
|
|
Age, Continuous
|
29.4 years
STANDARD_DEVIATION 11.1 • n=13 Eyes
|
36.8 years
STANDARD_DEVIATION 13.2 • n=4 Eyes
|
31.2 years
STANDARD_DEVIATION 11.6 • n=17 Eyes
|
|
Sex: Female, Male
Female
|
10 Eyes
n=13 Eyes
|
2 Eyes
n=4 Eyes
|
12 Eyes
n=17 Eyes
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
7 participants
n=7 Participants
|
4 participants
n=4 Participants
|
11 participants
n=11 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: 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"
Average keratometry across the anterior topography of the cornea computed by a validated topographer
Outcome measures
| Measure |
Pulsed, Accelerated
n=13 Eyes
18mW, 5 seconds on, 5 seconds off, 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.
|
Conventional
n=4 Eyes
9mW continuous, 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.
|
|---|---|---|
|
Mean Keratometry in Diopters
Screening
|
51.0 Diopters
Standard Deviation 9.9
|
49.8 Diopters
Standard Deviation 4.8
|
|
Mean Keratometry in Diopters
3 months
|
50.3 Diopters
Standard Deviation 7.8
|
49.0 Diopters
Standard Deviation 5.6
|
|
Mean Keratometry in Diopters
6 months
|
46.6 Diopters
Standard Deviation .9
|
49.1 Diopters
Standard Deviation 5.5
|
|
Mean Keratometry in Diopters
12 months
|
47.9 Diopters
Standard Deviation 11.3
|
45.8 Diopters
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: 1 yearPopulation: 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.
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.
Outcome measures
| Measure |
Pulsed, Accelerated
n=13 Eyes
18mW, 5 seconds on, 5 seconds off, 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.
|
Conventional
n=4 Eyes
9mW continuous, 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.
|
|---|---|---|
|
Best Corrected Visual Acuity With Spectacles or Contact Lenses
Screening · 20/25 or better
|
0 Eyes
|
0 Eyes
|
|
Best Corrected Visual Acuity With Spectacles or Contact Lenses
Screening · 20/30 - 20/50
|
0 Eyes
|
1 Eyes
|
|
Best Corrected Visual Acuity With Spectacles or Contact Lenses
Screening · 20/60 - 20/200
|
8 Eyes
|
2 Eyes
|
|
Best Corrected Visual Acuity With Spectacles or Contact Lenses
Screening · Worse than 20/200
|
5 Eyes
|
1 Eyes
|
|
Best Corrected Visual Acuity With Spectacles or Contact Lenses
1 month post-procedure · 20/25 or better
|
0 Eyes
|
1 Eyes
|
|
Best Corrected Visual Acuity With Spectacles or Contact Lenses
1 month post-procedure · 20/30 - 20/50
|
6 Eyes
|
1 Eyes
|
|
Best Corrected Visual Acuity With Spectacles or Contact Lenses
1 month post-procedure · 20/60 - 20/200
|
2 Eyes
|
1 Eyes
|
|
Best Corrected Visual Acuity With Spectacles or Contact Lenses
1 month post-procedure · Worse than 20/200
|
0 Eyes
|
0 Eyes
|
|
Best Corrected Visual Acuity With Spectacles or Contact Lenses
3 months post- procedure · 20/25 or better
|
1 Eyes
|
1 Eyes
|
|
Best Corrected Visual Acuity With Spectacles or Contact Lenses
3 months post- procedure · 20/30 - 20/50
|
6 Eyes
|
2 Eyes
|
|
Best Corrected Visual Acuity With Spectacles or Contact Lenses
3 months post- procedure · 20/60 - 20/200
|
1 Eyes
|
0 Eyes
|
|
Best Corrected Visual Acuity With Spectacles or Contact Lenses
3 months post- procedure · Worse than 20/200
|
1 Eyes
|
0 Eyes
|
|
Best Corrected Visual Acuity With Spectacles or Contact Lenses
6 months post-procedure · 20/25 or better
|
1 Eyes
|
1 Eyes
|
|
Best Corrected Visual Acuity With Spectacles or Contact Lenses
6 months post-procedure · 20/30 - 20/50
|
5 Eyes
|
1 Eyes
|
|
Best Corrected Visual Acuity With Spectacles or Contact Lenses
6 months post-procedure · 20/60 - 20/200
|
0 Eyes
|
1 Eyes
|
|
Best Corrected Visual Acuity With Spectacles or Contact Lenses
6 months post-procedure · Worse than 20/200
|
0 Eyes
|
0 Eyes
|
|
Best Corrected Visual Acuity With Spectacles or Contact Lenses
12 months post-procedure · 20/25 or better
|
1 Eyes
|
1 Eyes
|
|
Best Corrected Visual Acuity With Spectacles or Contact Lenses
12 months post-procedure · 20/30 - 20/50
|
1 Eyes
|
1 Eyes
|
|
Best Corrected Visual Acuity With Spectacles or Contact Lenses
12 months post-procedure · 20/60 - 20/200
|
0 Eyes
|
1 Eyes
|
|
Best Corrected Visual Acuity With Spectacles or Contact Lenses
12 months post-procedure · Worse than 20/200
|
0 Eyes
|
0 Eyes
|
Adverse Events
Pulsed, Accelerated
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Conventional
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pulsed, Accelerated
n=7 participants at risk
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.
|
Conventional
n=4 participants at risk
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.
|
|---|---|---|
|
Eye disorders
Photophobia
|
14.3%
1/7 • Number of events 1 • 1 year
|
0.00%
0/4 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place