Keratoconus, UnstablePhase 1NCT03918408
Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking
A Phase 1 study testing PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution in people with Keratoconus, Unstable and Bacterial Keratitis, run by Pacific Clear Vision Institute at 1 site in United States.
Trial summary
To determine whether the Peschke PXL-330 system is safe and effective in the treatment of corneal thinning conditions. Read more about this study
- Who is it for?
- Ages 12 to 45 years
- Conditions the study is for
- Keratoconus, Unstable, Bacterial Keratitis, Ectasia of Cornea
- What is being tested?
- PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to Dec 2030
- Phase
- Phase 1
- 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 12 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects who have one or both eyes that meet criteria 1 \& 2 and 1 or more of the following criteria will be considered candidates for this study.
- 12 years of age or older
- Evidence of progressive keratoconus (based on the discretion of the physician as evidenced by an increase in astigmatism, asymmetry, or worsening vision in the last 3 or more months)
- Presence of central or inferior steepening.
- Axial topography consistent with keratoconus
- Presence of one or more findings associated with keratoconus such as:
Show all 42Show fewer
- 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/Galilei/Orbscan/Cassini map or topography map
- Posterior corneal elevation >16 microns
- Thinnest corneal point <485 microns
- AvaGen (Avellino Labs) genetic testing keratoconus risk score of 67 or higher (high risk).
- Signed written informed consent
- Willingness and ability to comply with schedule for follow-up visits
- For 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
- Scleral Lenses
- Investigator Discretion [Discontinuation of scleral lenses not required unless there is clinical evidence of corneal hypoxia (e.g. corneal neovascularization) at time of screening]
- Signed written informed consent
- Willingness and ability to comply with schedule for follow-up visits
- 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 <330 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.
- 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 active medical implants (e.g. cardiac pacemakers)'
- Patients who are aphakic/ pseudophakic
Who cannot join
None listed.
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
Pacific Clear Vision Institute
Eugene, Oregon, 97401
BALAMURALI AMBATI, MD, 706-231-3958, bambati@pcvi.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 determine whether the Peschke PXL-330 system 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.
- Being tested
- PXL-330 Platinum device for crosslinking with Peschke ribofflavin 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 ribofflavin 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 | 18 mW, 5 sec, 5 sec off, 10 minutes of illumination Receives: Combination Product: PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution |
| Conventional | Active comparator | 9 mW, continuous 10 minutes of illumination Receives: Combination Product: PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution |
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: 12 months
Secondary outcomes (1)
Best corrected visual acuity
Measurement of best corrected visual acuity on the validated early-treatment diabetic retinopathy study scale
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 posted17 Apr 2019
- Study start1 Sep 2019
- Primary completionDec 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Treatment of patients with disease
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pacific Clear Vision Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BALAMURALI AMBATI, MD, PhD, Principal investigator, PCVI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03918408
- Sponsor's protocol ID
- 1005312
- Status last verified
- Nov 2024
- First submitted
- 14 Apr 2019
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will be stored 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.
Publications
Caporossi A, Baiocchi S, Mazzotta C, Traversi C, Caporossi T. Parasurgical therapy for keratoconus by riboflavin-ultraviolet type A rays induced cross-linking of corneal collagen: preliminary refractive results in an Italian study. J Cataract Refract Surg. 2006 May;32(5):837-45. doi: 10.1016/j.jcrs.2006.01.091.
PubMed 16765803Caporossi A, Mazzotta C, Baiocchi S, Caporossi T. Long-term results of riboflavin ultraviolet a corneal collagen cross-linking for keratoconus in Italy: the Siena eye cross study. Am J Ophthalmol. 2010 Apr;149(4):585-93. doi: 10.1016/j.ajo.2009.10.021. Epub 2010 Feb 6.
PubMed 20138607Chatzis N, Hafezi F. Progression of keratoconus and efficacy of pediatric [corrected] corneal collagen cross-linking in children and adolescents. J Refract Surg. 2012 Nov;28(11):753-8. doi: 10.3928/1081597X-20121011-01.
PubMed 23347367Mazzotta C, Traversi C, Caragiuli S, Rechichi M. Pulsed vs continuous light accelerated corneal collagen crosslinking: in vivo qualitative investigation by confocal microscopy and corneal OCT. Eye (Lond). 2014 Oct;28(10):1179-83. doi: 10.1038/eye.2014.163. Epub 2014 Jul 25.
PubMed 25060847
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 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 in Eyes With Corneal Thinning Conditions
- ClinicalTrials.gov ID
- NCT03918408
- Acronym / sponsor ID
- 1005312
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Pacific Clear Vision InstituteUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 17 Apr 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 system 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
- Parallel groups
- Masking
- Double blind (participant, 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 for crosslinking with Peschke ribofflavin solution18 mW, 5 sec, 5 sec off, 10 minutes of illumination |
| Conventional | Active comparator | Combination Product: PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution9 mW, continuous 10 minutes of illumination |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (42 listed)
- Subjects who have one or both eyes that meet criteria 1 \& 2 and 1 or more of the following criteria will be considered candidates for this study.
- 12 years of age or older
- Evidence of progressive keratoconus (based on the discretion of the physician as evidenced by an increase in astigmatism, asymmetry, or worsening vision in the last 3 or more months)
- Presence of central or inferior steepening.
- Axial topography consistent with keratoconus
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 ribofflavin solutionAlso: Corneal crosslinkingRiboflavin 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: 12 months
Average keratometry across the anterior topography of the cornea computed by a validated Scheimpflug topographer
1 secondary outcome
Best corrected visual acuity
Time frame: 12 months
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 12 Nov 2024.
- Background: PubMed 16765803Caporossi A, Baiocchi S, Mazzotta C, Traversi C, Caporossi T. Parasurgical therapy for keratoconus by riboflavin-ultraviolet type A rays induced cross-linking of corneal collagen: preliminary refractive results in an Italian study. J Cataract Refract Surg. 2006 May;32(5):837-45. doi: 10.1016/j.jcrs.2006.01.091.
- Background: PubMed 20138607Caporossi A, Mazzotta C, Baiocchi S, Caporossi T. Long-term results of riboflavin ultraviolet a corneal collagen cross-linking for keratoconus in Italy: the Siena eye cross study. Am J Ophthalmol. 2010 Apr;149(4):585-93. doi: 10.1016/j.ajo.2009.10.021. Epub 2010 Feb 6.
- Background: PubMed 23347367Chatzis N, Hafezi F. Progression of keratoconus and efficacy of pediatric [corrected] corneal collagen cross-linking in children and adolescents. J Refract Surg. 2012 Nov;28(11):753-8. doi: 10.3928/1081597X-20121011-01.
- Background: PubMed 25060847Mazzotta C, Traversi C, Caragiuli S, Rechichi M. Pulsed vs continuous light accelerated corneal collagen crosslinking: in vivo qualitative investigation by confocal microscopy and corneal OCT. Eye (Lond). 2014 Oct;28(10):1179-83. doi: 10.1038/eye.2014.163. Epub 2014 Jul 25.
- Individual participant dataSharing planned: No. Individual participant data will be stored 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.
BALAMURALI AMBATI, MD, PhD principal investigator
PCVI
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 ribofflavin solution in people with Keratoconus, Unstable and Bacterial Keratitis, run by Pacific Clear Vision Institute 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 42 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: looking for participants now, as of the sponsor's last update on 12 Nov 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 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?
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?
Contact BALAMURALI AMBATI, MD, PhD (541-343-5000, bambati@pcvi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean keratometry in diopters (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03918408, which also lists 4 linked publications.
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 Nov 2024.