Cornea Crosslinking for Keratoconus

(CXL Trial)

Overseen By GREGORY R Cohen, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Cohen Laser and Vision Center

Disqualifiers: Active infections, Collagen vascular disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 day

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called cornea crosslinking, using the PXL Platinum 330 system, to evaluate its effectiveness for individuals with keratoconus or other conditions that cause the cornea to thin or bulge. The treatment involves applying special eye drops followed by a brief exposure to UV light. Suitable candidates include those diagnosed with keratoconus or similar corneal thinning conditions, exhibiting signs like a bulging cornea or changes in vision. Participants must be generally healthy and able to adhere to the trial's follow-up schedule. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in eye care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, contact lens wearers must stop wearing their lenses for a certain period before the screening.

What prior data suggests that the PXL Platinum 330 system is safe for cornea crosslinking?

Research shows that the PXL Platinum 330 system, used to strengthen the cornea, is generally safe for individuals with thinning corneas. Studies have found that patients tolerate the treatment well, experiencing only minor side effects such as temporary eye discomfort or redness after the procedure. The system strengthens the cornea, a crucial part of the eye, by using a vitamin B2 solution and UVA light. As this treatment is still under investigation, it is promising that it has advanced to this stage without major safety concerns, indicating it is safe enough for continued testing in people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for keratoconus?

Unlike the standard of care for keratoconus, which typically involves corneal collagen cross-linking using riboflavin and UVA light, the PXL Platinum 330 system offers a unique approach by utilizing a riboflavin 0.25% solution coupled with a continuous UVA light dose of 9mW/cm² for a shorter duration. Researchers are excited about this treatment because the specific riboflavin concentration and continuous light mode might enhance the cross-linking process, potentially leading to more effective stabilization of the cornea in a shorter time frame. This method aims to improve patient comfort and reduce treatment time, which could make it a more appealing option compared to the traditional methods.

What evidence suggests that the PXL Platinum 330 system is effective for cornea thinning conditions?

Research shows that the PXL Platinum 330 system, which trial participants will receive, can help treat conditions where the cornea becomes thin, such as Keratoconus. Studies have found that this system uses a special light treatment to strengthen the cornea. The process involves applying riboflavin (a type of vitamin B) to the eye and then shining UVA light on it. Early results suggest that this method can strengthen and stabilize the cornea. The treatment aims to slow or stop corneal thinning, potentially improving vision and preventing further damage. ^{1 2 3 4 6}

Who Is on the Research Team?

Kelly Fitzgerald

Principal Investigator

WCG IRB

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Keratoconus or similar conditions causing cornea thinning. Participants must show signs like Fleischer ring, Vogt's striae, and have a specific shape to their cornea. Those with other medical or eye issues are not eligible.

Inclusion Criteria

Decentered corneal apex

Fleischer ring

Apical Corneal scarring consistent with Bowman's breaks

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive cornea collagen crosslinking using the PXL Platinum 330 system with riboflavin and UVA light

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with evaluations at multiple time points

12 months

1 day, 1 week, 1, 3, 6, and 12 months (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• PXL Platinum 330 system

Trial Overview The study tests the PXL-Platinum 330 system's ability to strengthen the cornea in patients with Keratoconus by using a technique called crosslinking.

How Is the Trial Designed?

Group I: PXL 330 Experimental Treatment 1 Intervention

Participants will receive riboflavin 0.25% solution (Peschke TE), one drop every minute for 25 minutes to the eye, followed by UVA light 9mW/cm2 continuous mode for 10 minutes

PXL Platinum 330 system is already approved in United States for the following indications:

Approved in United States as PXL Platinum 330 system for:

• Keratoconus
• Post-refractive corneal ectasia
• Pellucid marginal degeneration
• Refractory corneal ulcers

Who Is Running the Clinical Trial?

Cohen Laser and Vision Center

Lead Sponsor

Trials

1

Recruited

300+

Published Research Related to This Trial

The Athens Protocol, which combines topography-guided partial PRK with corneal cross-linking, showed significant improvements in visual acuity and corneal shape in 39 pediatric patients with keratoconus over a 4-year follow-up period.

While the procedure was generally safe and effective, two cases of late-onset deep corneal haze were noted, highlighting a potential complication in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Stability With the Athens Protocol (Topography-Guided Partial PRK Combined With Cross-Linking) in Pediatric Patients With Keratoconus. Kanellopoulos, AJ., Vingopoulos, F., Sideri, AM.[2019]

The study found that cross-linkage in posterior spinal constructs does not significantly improve stability under axial loading but has a more pronounced effect under torsion loading, indicating its importance in certain stress conditions.

Fatigue tests showed that spinal implants without cross-linkage could endure 1 million cycles at loads of 500-750 N, but their endurance dropped significantly at 1,000 N, suggesting that cross-linkage could help improve the endurance limits of spinal implants, especially for patients with higher physiological loads.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of cross-linkage on fatigue life and failure modes of stainless steel posterior spinal constructs. Stambough, JL., Sabri, EH., Huston, RL., et al.[2006]

A 62-year-old male with a known severe allergy to epoxy resin experienced significant pain and erythema after receiving a PEEK-containing medical device, suggesting a potential allergic reaction to PEEK.

This case highlights the importance of considering cross-reactivity between materials like PEEK and epoxy resin, especially since PEEK is widely used in medical devices and the sensitization route remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Allergic Reaction to Polyether Ether Ketone Following Cross-Reactivity to Epoxy Resin. Kofler, L., Wambacher, M., Schweinzer, K., et al.[2021]

A 14-year-old boy with advanced bilateral keratoconus showed significant improvement after treatment with the combined MARK + CXL intervention, with long-term follow-up results indicating stabilization of the condition and enhanced visual acuity.

The treatment led to notable decreases in corneal steepness (Kmax) and increases in corneal thickness, demonstrating that conservative approaches can effectively manage severe keratoconus in young patients without the need for corneal transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mini Asymmetric Radial Keratotomy and Corneal Cross-linking for the Treatment of a Bilateral Stage IV Keratoconus in a 14-year-old Child. Abbondanza, M., Abbondanza, G., De Felice, V.[2022]

The study analyzed tomographic features of pellucid-like keratoconus (PLK) and identified that the claw pattern on the anterior sagital map (ASM) is not exclusive to pellucid marginal degeneration (PMD), as it can also appear in PLK cases.

A new diagnostic sign, the 'bell' sign on the pachymetry map, was found to be present in all PMD cases, making it a useful tool for differentiating PMD from PLK, where this sign was absent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pellucid-like keratoconus. Sinjab, MM., Youssef, LN.[2021]

In a study involving 233 patients with hyperopia, 12-month results showed that 91% achieved uncorrected visual acuity of 20/40 or better, indicating high efficacy of conductive keratoplasty (CK) for treating hyperopia.

The procedure demonstrated good safety and stability, with 58% of patients achieving a manifest refractive spherical equivalent within +/- 0.50 D, and minimal changes in residual refraction after 6 months, suggesting that CK provides a stable correction for hyperopia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conductive keratoplasty for the correction of hyperopia. Asbell, PA., Maloney, RK., Davidorf, J., et al.[2022]

In a study involving 126 patients (79 LASIK and 47 PRK), both simultaneous LASIK and PRK with cornea inlay implantation were found to be effective treatments for presbyopia, meeting FDA efficacy criteria with high rates of achieving good near visual acuity (95% for LASIK and 83% for PRK at 20/40 vision).

Both procedures demonstrated similar safety profiles, with 92% of the LASIK group and 95% of the PRK group achieving 20/40 or better distance vision at 6 months, indicating that they are viable options for improving vision in presbyopic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective Comparison of Visual Outcomes After KAMRA Corneal Inlay Implantation With Simultaneous PRK or LASIK. Moshirfar, M., Bean, AE., Albarracin, JC., et al.[2018]

In a study of 172 patients who underwent surgery for degenerative lumbar spinal diseases, significant improvements in low back pain and leg pain were observed postoperatively, with VAS and ODI scores showing high statistical significance (p < 0.0001).

While dynamic stabilization using PEEK rods did not lead to significant radiological correction of lumbar lordosis, the mid-term clinical outcomes were satisfactory, with a low reoperation rate of 5.8% and a low incidence of adjacent segment disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polyetheretherketone Rods in Lumbar Spine Degenerative Disease: Mid-term Results in a Patient Series Involving Radiological and Clinical Assessment. Ogrenci, A., Koban, O., Yaman, O., et al.[2021]

A novel cross-link configuration that passes through the base of the spinous processes significantly increased the mechanical resistance of spinal constructs in pullout and flexion-compression tests compared to a conventional cross-link system, indicating improved stability.

This new design showed greater resistance to construct failure, particularly under flexion-compression forces, suggesting it may enhance the safety and efficacy of spinal instrumentation in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomechanical Analysis of a Pedicle Screw-Rod System with a Novel Cross-Link Configuration. Nakajima, Y., Hara, M., Umebayashi, D., et al.[2020]

In a study of 321 patients with spinal metastases or primary bone tumors, the use of carbon-fiber-reinforced (CFR) PEEK pedicle screw systems demonstrated a low complication rate, with only 9.3% experiencing intraoperative complications and 17.1% requiring revision surgery for postoperative issues.

CFR-PEEK implants showed rare implant-related complications, such as a 3.4% rate of intraoperative screw breakage and 2.2% screw loosening, making them a safe and effective alternative to traditional titanium implants for spinal stabilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CFR-PEEK Pedicle Screw Instrumentation for Spinal Neoplasms: A Single Center Experience on Safety and Efficacy. Joerger, AK., Seitz, S., Lange, N., et al.[2022]

In a study of 17 pediatric patients with severe kyphosis (greater than 60°), the use of posterior spinal fusion with sublaminar bands resulted in a low rate of proximal junctional kyphosis (PJK) at 5.8%, which is lower than rates reported in previous studies.

The technique demonstrated effective correction of kyphosis, reducing preoperative angles from an average of 62°-111° to 12°-55° postoperatively, indicating both safety and efficacy in managing spinal deformities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of Proximal Junctional Kyphosis & Failure Using Sublaminar Bands in a Hybrid Construct in Pediatric Kyphosis Deformity. Battista, C., Wild, C., Kreul, S., et al.[2022]

Aphakic/pseudophakic corneal edema was identified as the leading reason for penetrating keratoplasty (PKP) in Greece, accounting for 29.1% of cases, followed closely by keratoconus at 26%.

The study revealed a significant increase in the prevalence of regrafts as an indication for PKP over the 25-year period, indicating a trend that may reflect changes in patient management or surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changing indications for penetrating keratoplasty in Greece, 1982-2006: a multicenter study. Siganos, CS., Tsiklis, NS., Miltsakakis, DG., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04213885

Safety and Effectiveness of the PXL Platinum 330 System ... Study Overview. Brief Summary. To determine whether the Peschke PXL-330 is safe and effective in the treatment of corneal thinning conditions.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03918408

Safety and Effectiveness of the PXL-Platinum 330 System ... To determine whether the Peschke PXL-330 system is safe and effective in the treatment of corneal thinning conditions. Detailed Description. Patients with ...

3. ophtec.com ophtec.com/hubfs/Producten/PDP%20downloads/A901000636-1%20PXL%20Platinum%20330%20Folder%20e-mail.pdf

PXL Platinum 330 Variable settings from 3 mW up to 30 mW with simultaneous radiation time adjustment. *Continuous, individually customable pulsed and LASIK radiation modes.

4. withpower.com withpower.com/trial/phase-1-dilatation-pathologic-8-2019-0bff6

Corneal Cross-Linking for Keratoconus This trial is testing a device called the PXL Platinum 330 system, which uses a special light treatment to strengthen the cornea. It targets patients with ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05255107/safety-and-effectiveness-of-the-pxl-platinum-330-system-with-riboflavin-solution-for-previously-untreated-corneal-ulcers

Safety and Effectiveness of the PXL Platinum 330 System ... This study is being conducted to evaluate the safety and effectiveness of using the PXL Platinum 330 System with riboflavin solution for performing corneal ...

6. trialx.com trialx.com/clinical-trials/listings/275969/safety-and-effectiveness-of-the-pxl-platinum-330-system-for-corneal-collagen-cross-linking-in-eyes-with-corneal-thinning-conditions/?&geo_lat=44.0462362&geo_lng=-123.0220289&radius=10&place=Springfield&user_country=United%20States

Safety and Effectiveness of the PXL-Platinum 330 System ... Overview. To determine whether the Peschke PXL-330 system is safe and effective in the treatment of corneal thinning conditions.