KeratoconusPhase 2NCT04240457
Safety and Efficacy of Corneal Crosslinking Using the PXL-Platinum 330 for Eyes With Corneal Ectatic Conditions
A Phase 2 study testing Epithelial-on Corneal Crosslinking with the PXL 330 Platinum system. in people with Keratoconus and Cornea Ectasia, run by Arbor Center for Eye Care at 1 site in United States.
Trial summary
To evaluate the safety and effectiveness of the PXL Platinum 330 device for performing Corneal Crosslinking in patients with corneal thinning conditions. Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Keratoconus, Cornea Ectasia
- What is being tested?
- Epithelial-on Corneal Crosslinking with the PXL 330 Platinum system.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2020to 18 Feb 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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:
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- 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 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:
- 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:
- 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:
- History of or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, acanthamoeba, 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
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Arbor Center for Eye Care
Orland Park, Illinois, 60467
About this study
Official title: Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Crosslinking in Eyes With Corneal Ectatic Conditions
To evaluate the safety and effectiveness of the PXL Platinum 330 device for performing Corneal Crosslinking in patients 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, intraocular pressure and visual function questionnaire assessments.
- Conditions
- Keratoconus, Cornea Ectasia
- Being tested
- Epithelial-on Corneal Crosslinking with the PXL 330 Platinum system.
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epithelial-on Corneal Crosslinking with the PXL 330 Platinum system.Combination product
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.
| Study group | Role | What they receive |
|---|---|---|
| Pulsed, accelerated | Experimental | 18mW, 5 seconds on, 5 seconds off, 10 minutes of illumination. Receives: Combination Product: Epithelial-on Corneal Crosslinking with the PXL 330 Platinum system. |
| Conventional | Active comparator | 9mW continuous, 10 minutes of illumination. Receives: Combination Product: Epithelial-on Corneal Crosslinking with the PXL 330 Platinum system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Keratometry in Diopters
Average keratometry across the anterior topography of the cornea computed by a validated topographer
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start8 Jul 2020
- Primary completion18 Feb 2023
- Study completion18 Feb 2023
Why it stopped: Study was terminated due to enrollment and other challenges attributable to the Covid-19 public health emergency.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Treatment of patients with disease
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arbor Center for Eye Care
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Lubeck, MD, Principal investigator, Arbor Center for Eye Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240457
- Sponsor's protocol ID
- 330019
- Status last verified
- Nov 2024
- First submitted
- 22 Jan 2020
- Last updated
- 12 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. 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 Crosslinking in Eyes With Corneal Ectatic Conditions
- ClinicalTrials.gov ID
- NCT04240457
- Acronym / sponsor ID
- 330019
- Conditions
- Keratoconus, Cornea Ectasia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to enrollment and other challenges attributable to the Covid-19 public health emergency.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Arbor Center for Eye CareUniversity, hospital or other
- Study start
- 8 Jul 2020 (actual)
- Primary completion
- 18 Feb 2023 (actual)
- Study completion
- 18 Feb 2023 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Posted 23 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Treatment of patients with disease
| Arm | Type | Receives |
|---|---|---|
| Pulsed, accelerated | Experimental | Combination Product: Epithelial-on Corneal Crosslinking with the PXL 330 Platinum system.18mW, 5 seconds on, 5 seconds off, 10 minutes of illumination. |
| Conventional | Active comparator | Combination Product: Epithelial-on Corneal Crosslinking with the PXL 330 Platinum system.9mW continuous, 10 minutes of illumination. |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (37 listed)
- 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
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 |
|---|---|---|
| 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. | Combination product | Conventional, Pulsed, accelerated |
Primary outcome
Mean Keratometry in Diopters
Time frame: 1 year
Average keratometry across the anterior topography of the cornea computed by a validated topographer
1 secondary outcome
Best Corrected Visual Acuity With Spectacles or Contact Lenses
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
David Lubeck, MD principal investigator
Arbor Center for Eye Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Epithelial-on Corneal Crosslinking with the PXL 330 Platinum system. in people with Keratoconus and Cornea Ectasia, run by Arbor Center for Eye Care 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 37 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: stopped early, as of the sponsor's last update on 12 Dec 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Keratometry in Diopters (time frame: 1 year). 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 12 Dec 2024.