Corneal EctasiaPhase 1/2NCT04401865
Safety and Effectiveness of the PXL-Platinum 330 System
A Phase 1/2 study testing PXL-330 Platinum device for crosslinking with Peschke riboflavin solution in people with Corneal Ectasia and Keratoconus, run by Colorado Eye Consultants/Cornea Consultants of Colorado at 3 sites in United States.
Trial summary
To evaluate the safety and effectiveness of the PXL Platinum 330 system for performing corneal cross-linking (CXL) for the treatment of ectatic disorders. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Corneal Ectasia, Keratoconus, Pellucid Marginal 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
- 300 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jun 2020to 30 Jun 2023
- Phase
- Phase 1/2
- 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
- Diagnosis of keratoconus, forme fruste keratoconus, post-LASIK ectasia, pellucid marginal degeneration, forme fruste pellucid marginal degeneration, history of radial keratotomy with fluctuating vision, Terrien's marginal degeneration.
- Must have provided informed consent, documented it in writing, and have been given a copy of the signed informed consent form.
- Must be willing and able to return for scheduled treatment and follow-up examinations for the duration of the study.
- Must be at least 8 years of age.
- Non-consenting/impaired individuals with a LAR's signature
Who cannot join
- Corneal thickness < 300 microns measured by ultrasound or Pentacam.
- Contraindications or sensitivities to any study medications or their components.
- Pregnancy or breastfeeding.
- Any history of Herpes simplex corneal disease in an eye to be treated.
- Nystagmus or any other condition that would, in the judgement of the investigator, prevent a steady gaze during the treatment.
- Inability to cooperate with diagnostic tests.
- Current enrollment in another ophthalmic clinical trial.
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 2 recruiting
- Recruiting
Cleveland Eye Clinic
Brecksville, Ohio, 44141
Erin Kus-Kreidler, 216-503-6535, ekus-kreidler@clevelandeyeclinic.com
Shamik Bafna, MD
- Active, not recruiting
Chicago Cornea Consultants, Ltd.
Highland Park, Illinois, 60035
- Recruiting
Colorado Eye Consultants/Corneal Consultants of Colorado
Littleton, Colorado, 80120
Shivam Patel, BS, 720-709-7523, spatel@corneaonline.com
Wendy Bigger, 720-709-7533, wbigger@corneaonline.com
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
To evaluate the safety and effectiveness of the PXL Platinum 330 system for performing corneal cross-linking (CXL) for the treatment of ectatic disorders.
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 pachymetry.
- 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 cross-linking
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 | 5 mW, 10 sec on, 10 sec off, 24 minutes of illumination Intervention: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution Receives: Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution |
| Conventional | Active comparator | 4 mW, 10 sec on, 10 sec off, 30 minutes of illumination Intervention: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution 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.
Corrected distance visual acuity
Change in corrected distance visual acuity (CDVA) at the last required study visit (6 months post-op), compared to baseline.
Measured: 6 months
Secondary outcomes (2)
Uncorrected visual acuity
Change in UCVA at 6 months, compared to baseline.
Measured: 6 months
Keratometry
Change in Kmax, 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 May 2020
- Study start1 Jun 2020
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal EctasiaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colorado Eye Consultants/Cornea Consultants of Colorado
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- S. Lance Forstot, M.D., Principal investigator, Colorado Eye Consultants/Corneal Consultants of Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04401865
- Sponsor's protocol ID
- PXL-330
- Status last verified
- Jan 2022
- First submitted
- 20 May 2020
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 Jan 2022. 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
- NCT04401865
- Acronym / sponsor ID
- PXL-330
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Colorado Eye Consultants/Cornea Consultants of ColoradoIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 26 May 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.
To evaluate the safety and effectiveness of the PXL Platinum 330 system for performing corneal cross-linking (CXL) for the treatment of ectatic disorders.
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 pachymetry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulsed, Accelerated | Experimental | Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution5 mW, 10 sec on, 10 sec off, 24 minutes of illumination Intervention: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution |
| Conventional | Active comparator | Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution4 mW, 10 sec on, 10 sec off, 30 minutes of illumination Intervention: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of keratoconus, forme fruste keratoconus, post-LASIK ectasia, pellucid marginal degeneration, forme fruste pellucid marginal degeneration, history of radial keratotomy with fluctuating vision, Terrien's marginal degeneration.
- Must have provided informed consent, documented it in writing, and have been given a copy of the signed informed consent form.
- Must be willing and able to return for scheduled treatment and follow-up examinations for the duration of the study.
- Must be at least 8 years of age.
- Non-consenting/impaired individuals with a LAR's signature
Key exclusion criteria (7 listed)
- Corneal thickness < 300 microns measured by ultrasound or Pentacam.
- Contraindications or sensitivities to any study medications or their components.
- Pregnancy or breastfeeding.
- Any history of Herpes simplex corneal disease in an eye to be treated.
- Nystagmus or any other condition that would, in the judgement of the investigator, prevent a steady gaze during the treatment.
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 cross-linkingRiboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea | Combination product | Conventional, Pulsed, Accelerated |
Primary outcome
Corrected distance visual acuity
Time frame: 6 months
Change in corrected distance visual acuity (CDVA) at the last required study visit (6 months post-op), compared to baseline.
2 secondary outcomes
Uncorrected visual acuity
Time frame: 6 months
Keratometry
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Individual participant dataSharing planned: No
Related trials for Corneal Ectasia
RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
Keratoconus, Ectasia
RecruitingPhase 2/3
Corneal Crosslinking for Treatment of Progressive Keratoconus or Corneal Ectasia
Keratoconus, Corneal Ectasia
RecruitingObservational study
Corneal Elastography and Patient Specific Modeling
Cornea; Ectasia, Refractive Errors
Not yet recruitingPhase 4
Outcomes of CTAK Surgery
Keratoconus, Corneal Ectasia
RecruitingPhase 3
Comparison of Epi-ON Corneal Collagen Crosslinking Performed Using an 18-Minute UVA Exposure vs. a 24-Minute UVA Exposure on Eyes With Ectatic Corneal Diseases
Keratoconus, Ectasia of Cornea
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.
S. Lance Forstot, M.D. principal investigator
Colorado Eye Consultants/Corneal Consultants of Colorado
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PXL-330 Platinum device for crosslinking with Peschke riboflavin solution in people with Corneal Ectasia and Keratoconus, run by Colorado Eye Consultants/Cornea Consultants of Colorado at 3 sites 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 5 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: status not confirmed, as of the sponsor's last update on 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shivam Patel, BS (720-709-7523, spatel@corneaonline.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corrected distance visual acuity (time frame: 6 months). 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 25 Jan 2022.