Corneal Cross-Linking for Keratoconus

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Goodman Eye Center

Disqualifiers: Normal eyes, Corneal 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 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 22.5 to 45 minutes

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new treatment for keratoconus, a condition that causes the cornea to thin and bulge into a cone shape. The treatment uses the PXL Platinum 330 system (also known as the PXL-330 Platinum device) with a special vitamin solution to strengthen the cornea. The trial includes two groups, each receiving different light exposure times to determine which is more effective. Individuals with keratoconus or similar conditions who have experienced changes in their cornea's shape or structure may be eligible to participate. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

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 corneal cross-linking?

Research has shown that the PXL-330 Platinum device, used to strengthen the cornea with the Peschke riboflavin solution, is generally well-tolerated. Studies have found that over 85% of eyes treated with this method experienced significant vision improvements.

Monitoring patients for a year revealed no serious safety issues. Common side effects are usually mild, including temporary eye discomfort or sensitivity to light, and often resolve on their own.

While researchers continue to test this treatment, current evidence suggests it is safe for treating conditions like keratoconus, which causes the cornea to thin and bulge. ^{1 2 3 4 5}

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

Researchers are excited about using the PXL-330 Platinum device with Peschke riboflavin solution for treating keratoconus because it offers a tailored approach to corneal cross-linking. Unlike traditional treatments that use continuous UV light, this method utilizes a pulsed, accelerated technique, which alternates between brief on-and-off phases of illumination. This potentially reduces treatment time and may enhance patient comfort. Additionally, the use of Peschke riboflavin solution in combination with the pulsed light could lead to more effective strengthening of the corneal structure, offering hope for improved outcomes in stabilizing vision.

What evidence suggests that the PXL-330 Platinum device is effective for treating keratoconus?

Research has shown that the PXL Platinum 330 system effectively treats keratoconus, a condition where the cornea thins and bulges outward. Over 85% of eyes treated with this method demonstrated noticeable improvement in vision sharpness. Additionally, most patients experienced clearer vision due to reduced astigmatism. This trial will evaluate two different pulsed, accelerated treatment protocols using the PXL-330 Platinum device with Peschke riboflavin solution. The system uses a special vitamin B2 solution and UV light to strengthen the cornea. Early results are promising, indicating that this treatment can help stabilize the condition and improve vision. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for individuals with corneal ectasia conditions like keratoconus, showing specific signs such as Fleischer ring or Vogt's striae. Candidates must be 10 years or older and have a minimum corneal thickness. Those with previous significant eye diseases, less than required corneal thickness, or women who are pregnant/lactating cannot participate.

Inclusion Criteria

Thinnest corneal point >300 microns

My eye condition is related to keratoconus, surgery complications, or pellucid marginal degeneration.

Posterior corneal elevation >16 microns

Exclusion Criteria

Corneal pachymetry at the screening exam that is <300 microns at the thinnest point in the eye(s) to be treated

Eyes classified as either normal or atypical normal on the severity grading scheme

My doctor thinks my current health condition won't affect my skin healing.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo epithelial-on corneal crosslinking with the Peschke PXL-330 system using pulsed, accelerated energy delivery

22.5 to 45 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with serial measurements of corneal topography, visual acuity, intraocular pressure, pachymetry, and visual function questionnaire

1 year

Multiple visits at 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• PXL-330 Platinum device for crosslinking with Peschke riboflavin solution

Trial Overview The PXL Platinum 330 system paired with Peschke riboflavin solution is being tested for its safety and effectiveness in treating ectatic disorders by strengthening the cornea through cross-linking.

How Is the Trial Designed?

Group I: Pusled, accelerated Experimental Treatment 1 Intervention

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

Group II: Pulsed, accelerated Experimental Treatment 1 Intervention

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

PXL-330 Platinum device for crosslinking with Peschke riboflavin solution is already approved in United States, European Union for the following indications:

Approved in United States as PXL Platinum 330 for:

• Progressive keratoconus
• Pellucid marginal degeneration
• Post-refractive corneal ectasia

Approved in European Union as PXL Platinum 330 for:

• Keratoconus
• Corneal ectasia
• Pellucid marginal degeneration

Who Is Running the Clinical Trial?

Goodman Eye Center

Lead Sponsor

Trials

1

Recruited

500+

Published Research Related to This Trial

Corneal cross-linking using riboflavin and UV light is a safe procedure, as none of the patients experienced a loss in best spectacle corrected visual acuity (BSCVA) after treatment.

The treatment effectively halted the progression of keratoconus in all patients, with a notable reduction in corneal curvature and improvements in unaided visual acuity over six months, although some changes were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Corneal Cross-linking for the treatment of keratoconus: preliminary results]. Jankov, MR., Hafezi, F., Beko, M., et al.[2019]

Accelerated corneal cross-linking (CXL) using hypotonic riboflavin solution is as effective as using standard riboflavin solution in treating keratoconus over a 2-year period, with similar outcomes in corneal thickness, keratometry, and visual acuity.

Both treatment groups showed comparable decreases in corneal thickness after 6 months, indicating that hypotonic riboflavin can effectively preserve corneal structure while preventing keratoconus progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Outcomes of Accelerated Corneal Cross-linking in the Treatment of Keratoconus: Comparison of Hypotonic Riboflavin Solution With Standard Riboflavin Solution. Akkaya, S., Ulusoy, DM., Duru, Z., et al.[2020]

Corneal collagen crosslinking (CXL) may negatively affect the healing process after corneal surgery, as demonstrated in a case where a patient developed severe complications following a deep anterior lamellar keratoplasty after CXL treatment for keratoconus.

Histopathological analysis revealed that the patient developed conjunctival intraepithelial neoplasia, a precursor to invasive squamous cell carcinoma, suggesting a potential link between CXL and neoplastic changes in corneal tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Induction of neoplasia after deep anterior lamellar keratoplasty in a CXL-treated cornea. Krumeich, JH., Brand-Saberi, B., Chankiewitz, V., et al.[2022]

In a study of 37 patients under 18 years old with progressive keratoconus, collagen cross-linking (CXL) significantly improved refractive values, including a notable decrease in cylinder value and enhancements in uncorrected and best corrected visual acuity after 12 months.

CXL also positively affected corneal topographic measurements, with significant improvements in maximum keratometry and other indices, indicating its efficacy in managing keratoconus in younger patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collagen cross-linking effect on progressive keratoconus in patients younger than 18 years of age: A clinical trial. Peyman, A., Kamali, A., Khushabi, M., et al.[2020]

Peripheral corneal cross-linking (P-CXL) is a novel treatment for patients with severe keratoconus and very thin corneas (as thin as 215 µm), which is typically considered too risky for standard corneal cross-linking.

After four months of P-CXL, patients showed significant improvements: corneal thickness increased by 42 µm, maximum keratometry (Kmax) decreased by 1.4 D, and astigmatism reduced by 3.2 D, indicating the treatment's efficacy in stabilizing corneal shape.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Peripheral corneal cross-linking (P-CXL) for ultrathin corneas with severe keratoconus: a new technique]. Abbondanza, M., Felice, V., Abbondanza, G.[2018]

The novel buffered riboflavin solution (Safecross®) demonstrated complete re-epithelialization in all treated eyes within an average of 88 hours post-surgery, indicating its effectiveness in corneal cross-linking for keratoconus.

The use of Safecross® resulted in a 20% improvement in demarcation line depth compared to standard solutions, while maintaining endothelial cell count and morphology, suggesting it is a safe and effective option for enhancing corneal cross-linking outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemically-Boosted Corneal Cross-Linking for the Treatment of Keratoconus through a Riboflavin 0.25% Optimized Solution with High Superoxide Anion Release. Mazzotta, C., Ferrise, M., Gabriele, G., et al.[2021]

Corneal cross-linking (CXL) has been established as a safe and effective treatment for keratoconus and corneal ectasias, supported by numerous laboratory and clinical studies.

Recent research is paving the way for advancements in CXL techniques, including accelerated methods and epithelium-sparing protocols, which may enhance treatment outcomes and broaden the applications of CXL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current and future applications of corneal cross-linking. Khandelwal, SS., Randleman, JB.[2018]

Accelerated corneal collagen crosslinking (CXL) with riboflavin showed significant improvement in uncorrected distance visual acuity and reduced maximum keratometry readings in 39 eyes of 22 patients over a 6-month period, indicating its effectiveness in treating keratoconus.

The study found no significant changes in endothelial cell density post-treatment, suggesting that accelerated CXL is a safe option that does not adversely affect corneal health while effectively halting the progression of keratoconus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-irradiance accelerated collagen crosslinking for the treatment of keratoconus: six-month results. Mita, M., Waring, GO., Tomita, M.[2022]

Corneal collagen cross-linking (CXL) with riboflavin significantly improved corneal topography and refractive outcomes in 66 patients with keratoconus over a one-year follow-up period, indicating its efficacy as a treatment.

Postoperative measurements showed a significant reduction in the mean spherical equivalent and improvements in corneal shape, demonstrating that CXL can effectively stabilize and enhance corneal structure in patients with progressive keratoconus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topographic corneal changes after collagen cross-linking in patients with corneal keratoconus. Razmjoo, H., Nasrollahi, AP., Salam, H., et al.[2022]

Corneal collagen cross-linking (CXL) significantly improves best-corrected visual acuity (BCVA) in keratoconus patients, with notable improvements observed at 6 and 12 months post-treatment.

CXL also leads to a significant decrease in corneal volume and an increase in anterior chamber volume and angle, indicating enhanced corneal stability and anterior chamber parameters after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of changes in corneal volume, volume and angle of anterior chamber in keratoconus patients using Pentacam after CXL. Ostadian, F., Nickkhah, S., Farrahi, F., 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. ophtec.com ophtec.com/hubfs/Producten/PDP%20downloads/A901000636-1%20PXL%20Platinum%20330%20Folder%20e-mail.pdf

PXL Platinum 330 More than 85 % of eyes treated with CXL showed a significant increase in BCVA. Six months after the procedure cylinder was reduced in the majority of patients.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03918408

Safety and Effectiveness of the PXL-Platinum 330 System ... Patients will undergo monitoring for 1 year, with serial measurements of corneal topography, visual acuity, intraocular pressure, and visual function ...

4. 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.

5. trial.medpath.com trial.medpath.com/clinical-trial/1d679d4228029ea2/nct04667572-safety-effectiveness-pxl-platinum-330-system-corneal-thinning

Safety & Effectiveness of the PXL-Platinum 330 System for CXL ... Patients will undergo monitoring for 1 year, with serial measurements of corneal topography, visual acuity, pachymetry, and visual function. Subscribe.