Keratoconus, UnstablePhase 2NCT04213885
Safety and Effectiveness of the PXL Platinum 330 System for Corneal Collagen Cross-Linking in Eyes With Corneal Thinning Position
A Phase 2 study testing PXL 330 Platinum device/Riboflavin in people with Keratoconus, Unstable and Ectasia Corneal, run by Eye Specialists of Indiana at 1 site in United States.
Trial summary
To determine whether the Peschke PXL-330 is safe and effective in the treatment of corneal thinning conditions. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Keratoconus, Unstable, Ectasia Corneal, Bacterial Keratitis
- What is being tested?
- PXL 330 Platinum device/Riboflavin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2020to 5 Aug 2024
- Phase
- Phase 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Eyes classified as normal or atypical normal on the severity grading scheme
- Corneal pachymetry at the screening exam that is <300 microns at the 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 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
Show all 10Show fewer
- A known sensitivity to the study medications
- Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment of diagnostic tests.
- Patients with a current condition that, in the physician's opinion, wold interfere with or prolong epithelial healing.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Eye Specialists of Indiana
Indianapolis, Indiana, 46220
About this study
Official title: Safety and Effectiveness of the PXL Platinum 330 System for Corneal Collagen Cross-Linking With Corneal Thinning Conditions
To determine whether the Peschke PXL-330 is safe and effective in the treatment of corneal thinning conditions.
Read the detailed description
Patients with progressive keratoconus, pellucid marginal degeneration, infectious keratitis, 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.
- Conditions
- Keratoconus, Unstable, Ectasia Corneal, Bacterial Keratitis
- Being tested
- PXL 330 Platinum device/Riboflavin
- 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/RiboflavinCombination product
30mW, 5 sec, 5 sec off, 10 minutes of illumination
| Study group | Role | What they receive |
|---|---|---|
| Pulsed Accelerated | Experimental | 30mW, 5 sec, 5 sec off, 10 minutes of illumination. Combination Product: PXL-330 Platinum device for cross linking with Peschke riboflavin solution will be used to load the cornea followed by UV-A cross linking of the cornea Receives: Combination Product: PXL 330 Platinum device/Riboflavin |
| Conventional | Active comparator | 9mW continuous, 10 minutes of illumination. Combination Product: PXL-330 Platinum device for cross linking with Peschke riboflavin solution will be used to load the cornea followed by UV-A cross linking of the cornea Receives: Combination Product: PXL 330 Platinum device/Riboflavin |
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 Scheimpflug topographer
Measured: 1 year
Secondary outcomes (1)
Best corrected visual acuity
Measurement of best corrected visual acuity on the validated early-treatment diabetic retinopathy study scale
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 posted30 Dec 2019
- Study start4 May 2020
- Primary completion5 Aug 2024
- Study completion5 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratoconus, UnstableStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eye Specialists of Indiana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04213885
- Sponsor's protocol ID
- PXL330-001
- Status last verified
- Aug 2024
- First submitted
- 27 Dec 2019
- Last updated
- 29 Aug 2024
- Results posted
- No
- 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 29 Aug 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 Collagen Cross-Linking With Corneal Thinning Conditions
- ClinicalTrials.gov ID
- NCT04213885
- Acronym / sponsor ID
- PXL330-001
- Conditions
- Keratoconus, Unstable, Ectasia Corneal, Bacterial Keratitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Eye Specialists of IndianaUniversity, hospital or other
- Study start
- 4 May 2020 (actual)
- Primary completion
- 5 Aug 2024 (actual)
- Study completion
- 5 Aug 2024 (actual)
- First posted
- 30 Dec 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 determine whether the Peschke PXL-330 is safe and effective in the treatment of corneal thinning conditions.
Detailed description
Patients with progressive keratoconus, pellucid marginal degeneration, infectious keratitis, 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.
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: PXL 330 Platinum device/Riboflavin30mW, 5 sec, 5 sec off, 10 minutes of illumination. Combination Product: PXL-330 Platinum device for cross linking with Peschke riboflavin solution will be used to load the cornea followed by UV-A cross linking of the cornea |
| Conventional | Active comparator | Combination Product: PXL 330 Platinum device/Riboflavin9mW continuous, 10 minutes of illumination. Combination Product: PXL-330 Platinum device for cross linking with Peschke riboflavin solution will be used to load the cornea followed by UV-A cross linking of the cornea |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Eyes classified as normal or atypical normal on the severity grading scheme
- Corneal pachymetry at the screening exam that is <300 microns at the 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 the 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/Riboflavin30mW, 5 sec, 5 sec off, 10 minutes of illumination | 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 Scheimpflug topographer
1 secondary outcome
Best corrected visual acuity
Time frame: 1 year
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 29 Aug 2024.
- 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 2 study testing PXL 330 Platinum device/Riboflavin in people with Keratoconus, Unstable and Ectasia Corneal, run by Eye Specialists of Indiana 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 0 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: finished, as of the sponsor's last update on 29 Aug 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?
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?
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 29 Aug 2024.