KeratoconusPhase 1NCT04667572
Safety & Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin Solution
A Phase 1 study testing PXL-330 Platinum device for crosslinking with Peschke riboflavin solution in people with Keratoconus and Pellucid Marginal Corneal Degeneration, run by Cornea Associates of Texas at 1 site in United States.
Trial summary
Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-linking in Eyes With Corneal Thinning Conditions Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Keratoconus, Pellucid Marginal Corneal Degeneration, Corneal Degeneration
- What is being tested?
- PXL-330 Platinum device for crosslinking with Peschke riboflavin solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 21 Aug 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 8 years of age or older
- Signed written informed consent
- Willingness and ability to comply with schedule for follow-up visits
- Contact Lens Wearers Only:
- Removal of contact lenses (if applicable) for the required period of time prior to the screening refraction: Soft, discontinue 3 days; Soft Extended Wear, discontinue 3 days; Soft Toric, discontinue 3 days; Rigid gas permeable, discontinue 2 Weeks (subjects who cannot function without wearing their contact lenses, may forgo discontinuation of contact lenses)
- And one or more of the following:
Show all 13Show fewer
- 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: 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/Orbscan map or topography map
- Posterior corneal elevation >16 microns
- Thinnest corneal point >300 microns
Who cannot join
- Eyes classified as either normal or atypical normal on the severity grading scheme.
- Corneal thickness < 300 microns measured by ultrasonic pachymetry or pentacam.
- 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, 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 a current condition that, in the physician's opinion, would interfere with or prolong epithelial healing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-Linking in Eyes With Corneal Thinning Conditions
Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-linking in Eyes With Corneal Thinning Conditions
Read the 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, pachymetry, and visual function.
- Conditions
- Keratoconus, Pellucid Marginal Corneal Degeneration, Corneal Degeneration, Corneal Ectasia
- Being tested
- PXL-330 Platinum device for crosslinking with Peschke riboflavin solution
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PXL-330 Platinum device for crosslinking with Peschke riboflavin solutionCombination product
Also called Corneal Crosslinking
Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea
| Study group | Role | What they receive |
|---|---|---|
| Pulsed 5mW/cm2 | Experimental | 5mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 36 minute total treatment time Receives: Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution |
| Pulsed 8mW/cm2 | Experimental | 8mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 22 minute and 30 seconds total treatment time Receives: Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
K-Max
Change in K-Max measured by corneal topography, compared to baseline
Measured: 12 Months
K-Mean
Change in K-Mean measured by corneal topography, compared to baseline
Measured: 12 Months
Secondary outcomes (3)
Uncorrected Visual Acuity
Change in uncorrected corrected visual acuity using snellen measurements, compared to baseline
Measured: 12 Months
Best Corrected Visual Acuity
Change in best corrected visual acuity using snellen measurements, compared to baseline
Measured: 12 Months
Central Pachymetry
Change in central pachymetry, measured by Pentacam compared to baseline
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start1 Feb 2021
- Primary completion21 Aug 2024
- Study completion21 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornea Associates of Texas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667572
- Sponsor's protocol ID
- PXL-330-CAT-2
- Status last verified
- Feb 2025
- First submitted
- 2 Dec 2020
- Last updated
- 11 Feb 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-Linking in Eyes With Corneal Thinning Conditions
- ClinicalTrials.gov ID
- NCT04667572
- Acronym / sponsor ID
- PXL-330-CAT-2
- Conditions
- Keratoconus, Pellucid Marginal Corneal Degeneration, Corneal Degeneration, Corneal Ectasia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Cornea Associates of TexasUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 21 Aug 2024 (actual)
- Study completion
- 21 Aug 2024 (actual)
- First posted
- 14 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-linking in Eyes 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, pachymetry, and visual function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulsed 5mW/cm2 | Experimental | Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution5mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 36 minute total treatment time |
| Pulsed 8mW/cm2 | Experimental | Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution8mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 22 minute and 30 seconds total treatment time |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- 8 years of age or older
- Signed written informed consent
- Willingness and ability to comply with schedule for follow-up visits
- Contact Lens Wearers Only:
- Removal of contact lenses (if applicable) for the required period of time prior to the screening refraction: Soft, discontinue 3 days; Soft Extended Wear, discontinue 3 days; Soft Toric, discontinue 3 days; Rigid gas permeable, discontinue 2 Weeks (subjects who cannot function without wearing their contact lenses, may forgo discontinuation of contact lenses)
Key exclusion criteria (7 listed)
- Eyes classified as either normal or atypical normal on the severity grading scheme.
- Corneal thickness < 300 microns measured by ultrasonic pachymetry or pentacam.
- 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, 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PXL-330 Platinum device for crosslinking with Peschke riboflavin solutionAlso: Corneal CrosslinkingRiboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea | Combination product | Pulsed 5mW/cm2, Pulsed 8mW/cm2 |
Primary outcome
K-Max
Time frame: 12 Months
Change in K-Max measured by corneal topography, compared to baseline
K-Mean
Time frame: 12 Months
Change in K-Mean measured by corneal topography, compared to baseline
3 secondary outcomes
Uncorrected Visual Acuity
Time frame: 12 Months
Best Corrected Visual Acuity
Time frame: 12 Months
Central Pachymetry
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PXL-330 Platinum device for crosslinking with Peschke riboflavin solution in people with Keratoconus and Pellucid Marginal Corneal Degeneration, run by Cornea Associates of Texas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
K-Max (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.