KeratoconusPhase 2NCT04094090
Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking in Eyes With Corneal Ectasia
A Phase 2 study testing PXL-330 Platinum device for crosslinking with Peschke riboflavin solution in people with Keratoconus and Pellucid Marginal Corneal Degeneration, run by Goodman Eye Center at 1 site 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 10 years and older
- Conditions the study is for
- Keratoconus, Pellucid Marginal Corneal Degeneration, Corneal Ectasia
- 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
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2019to 19 Oct 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 10 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 and 1 or more of the following criteria will be considered candidates for this study:
- 1.10 years of age or older 2. Presence of central or inferior steepening 3. Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration 4. 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
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- Apical Corneal scarring consistent with Bowman's breaks
- Scissoring of the retinoscopic reflex
- Crab-claw appearance on topography 5. Steepest keratometry (Kmax) value ≥ 47.20 D 6. I-S keratometry difference > 1.5 D on the Pentacam map or topography map 7. Posterior corneal elevation >16 microns 8. Thinnest corneal point >300 microns 9. 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 or Scleral 3 days Rigid gas permeable 2 weeks
Who cannot join
- All subjects meeting any of the following criteria will be excluded from this study:
- 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, acanthomeoeba, 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.
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- 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. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Goodman Eye Center
San Francisco, California, 94115
Daniel F Goodman, MD, 4154743333, swong@goodmaneyecenter.com
Daniel F Goodman, MD
About this study
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, pachymetry, and visual function questionnaire.
- 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, accelerated | Experimental | 4 mW, 10-15 sec on, 10-15sec off, 45 minutes of illumination Intervention: Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution Receives: Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution |
| Pusled, accelerated | Experimental | 8 mW, 10-15 sec on, 10-15 sec off, 22.5 minutes of illumination Intervention: Combination Product: 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.
Best-contact corrected visual acuity (BSCVA)
Change in BSCVA compared to baseline.
Measured: 3, 6, and 12 months
Secondary outcomes (2)
Uncorrected visual acuity
Change in UCVA compared to baseline.
Measured: 3, 6, and 12 months
Keratometry
Change in Kmax, compared to baseline.
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 posted18 Sep 2019
- Study start19 Oct 2019
- Primary completion19 Oct 2029 (estimated)
- Study completion19 Oct 2029 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- The study is a prospective, double-armed, randomized, single study.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goodman Eye Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094090
- Sponsor's protocol ID
- PXL-2211
- Status last verified
- Oct 2025
- First submitted
- 13 Sep 2019
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- 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 20 Oct 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 Cross-Linking in Eyes With Corneal Ectasia
- ClinicalTrials.gov ID
- NCT04094090
- Acronym / sponsor ID
- PXL-2211
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Goodman Eye CenterUniversity, hospital or other
- Study start
- 19 Oct 2019 (actual)
- Primary completion
- 19 Oct 2029 (estimated)
- Study completion
- 19 Oct 2029 (estimated)
- First posted
- 18 Sep 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.
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, pachymetry, and visual function questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The study is a prospective, double-armed, randomized, single study.
| Arm | Type | Receives |
|---|---|---|
| Pulsed, accelerated | Experimental | Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution4 mW, 10-15 sec on, 10-15sec off, 45 minutes of illumination Intervention: Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution |
| Pusled, accelerated | Experimental | Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution8 mW, 10-15 sec on, 10-15 sec off, 22.5 minutes of illumination Intervention: Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects who have one or both eyes that meet criteria 1 and 1 or more of the following criteria will be considered candidates for this study:
- 1.10 years of age or older 2. Presence of central or inferior steepening 3. Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration 4. Presence of one or more findings associated with keratoconus or pellucid marginal degeneration, such as:
- Fleischer ring
- Vogt's striae
- Decentered corneal apex
Key exclusion criteria (10 listed)
- 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:
- 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, accelerated, Pusled, accelerated |
Primary outcome
Best-contact corrected visual acuity (BSCVA)
Time frame: 3, 6, and 12 months
Change in BSCVA compared to baseline.
2 secondary outcomes
Uncorrected visual acuity
Time frame: 3, 6, and 12 months
Keratometry
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- 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.
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 PXL-330 Platinum device for crosslinking with Peschke riboflavin solution in people with Keratoconus and Pellucid Marginal Corneal Degeneration, run by Goodman Eye Center 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 10 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 20 Oct 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best-contact corrected visual acuity (BSCVA) (time frame: 3, 6, and 12 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 20 Oct 2025.