KeratoconusPhase 1NCT04177082
Safety and 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 older
- 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
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2020to 5 May 2022
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects who have one or both eyes that meet criteria 1-4 and also meet at least 1 or more of criteria 5-11 will be considered candidates for this study:
- 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 for the required period of time prior to the screening refraction:
Show all 23Show fewer
- Contact Lens Type Minimum Discontinuation Time Soft 3 days Soft Extended Wear 3 days Soft Toric 3 days Rigid gas permeable 2 Weeks
- Subjects who cannot function without wearing their contact lenses, may forgo discontinuation of contact lenses.
- 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
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-linking in Eyes With Corneal Thinning Conditions Using Peschke Riboflavin Solution
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 6mW/cm2 | Experimental | 6mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 30 minute total treatment time Receives: Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution |
| Pulsed 4mW/cm2 | Experimental | 4mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 45 minute 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, compared to baseline
Measured: 12 Months
K-Mean
Change in K-Mean, compared to baseline
Measured: 12 Months
Secondary outcomes (3)
Uncorrected Visual Acuity
Change in uncorrected visual acuity, compared to baseline
Measured: 12 Months
Best Corrected Visual Acuity
Change in best corrected visual acuity, compared to baseline
Measured: 12 Months
Central Pachymetry
Change in central pachymetry, 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 posted26 Nov 2019
- Study start10 Jan 2020
- Primary completion5 May 2022
- Study completion5 May 2022
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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornea Associates of Texas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tyrone McCall, MD, Principal investigator, Cornea Associates of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04177082
- Sponsor's protocol ID
- PXL-330-CAT
- Status last verified
- Sep 2022
- First submitted
- 22 Nov 2019
- Last updated
- 19 Oct 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will be held in a secure location. While summary outcomes data will be provided on request to other researchers and periodically at scientific conferences, protected health information will not.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-linking in Eyes With Corneal Thinning Conditions Using Peschke Riboflavin Solution
- ClinicalTrials.gov ID
- NCT04177082
- Acronym / sponsor ID
- PXL-330-CAT
- Conditions
- Keratoconus, Pellucid Marginal Corneal Degeneration, Corneal Degeneration, Corneal Ectasia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Cornea Associates of TexasUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 5 May 2022 (actual)
- Study completion
- 5 May 2022 (actual)
- First posted
- 26 Nov 2019 (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 6mW/cm2 | Experimental | Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution6mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 30 minute total treatment time |
| Pulsed 4mW/cm2 | Experimental | Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution4mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 45 minute total treatment time |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (23 listed)
- Subjects who have one or both eyes that meet criteria 1-4 and also meet at least 1 or more of criteria 5-11 will be considered candidates for this study:
- 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:
Key exclusion criteria (0 listed)
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 4mW/cm2, Pulsed 6mW/cm2 |
Primary outcome
K-Max
Time frame: 12 Months
Change in K-Max, compared to baseline
K-Mean
Time frame: 12 Months
Change in K-Mean, 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 19 Oct 2022.
- Individual participant dataSharing planned: No. Individual participant data will be held in a secure location. While summary outcomes data will be provided on request to other researchers and periodically at scientific conferences, protected health information will not.
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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.
Tyrone McCall, MD principal investigator
Cornea Associates of Texas
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 23 inclusion and 0 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 19 Oct 2022. 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 19 Oct 2022; AzTrials last refreshed its copy on 8 Nov 2026.