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

Trial Summary

What is the purpose of this trial?

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 conditions that weaken and misshape the cornea, such as progressive keratoconus and pellucid marginal degeneration. The treatment works by creating new connections between the fibers in the cornea, helping it stay strong and maintain its shape.

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 data supports the effectiveness of the treatment PXL-330 Platinum device for crosslinking with Peschke riboflavin solution in treating keratoconus?

Research shows that corneal cross-linking (CXL) is effective in slowing down the progression of keratoconus, a condition where the cornea (the clear front part of the eye) becomes thin and cone-shaped. Studies have demonstrated improvements in corneal thickness and shape after CXL, indicating its potential effectiveness in treating keratoconus. ^{1 2 3 4 5}

Is corneal cross-linking safe for humans?

Corneal cross-linking (CXL) is generally considered safe for treating keratoconus, with studies showing no adverse effects on corneal endothelium (the inner layer of the cornea) and complete healing of the corneal surface within a few days. However, long-term safety is still being studied, and there have been rare reports of complications after additional eye surgeries. ^{1 2 6 7 8}

How is the PXL-330 Platinum device treatment for keratoconus different from other treatments?

The PXL-330 Platinum device treatment for keratoconus is unique because it uses a specific riboflavin solution activated by ultraviolet A (UVA) light to strengthen the cornea, potentially offering a more targeted and effective approach compared to standard treatments. This method may be particularly beneficial for patients with very thin corneas, where traditional cross-linking methods are less effective. ^{1 2 3 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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) 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]

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]

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 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 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]

References

1. United States 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. [2020]

2. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Peripheral corneal cross-linking (P-CXL) for ultrathin corneas with severe keratoconus: a new technique]. [2018]

3. India pubmed.ncbi.nlm.nih.gov

Collagen cross-linking effect on progressive keratoconus in patients younger than 18 years of age: A clinical trial. [2020]

4. Brazil pubmed.ncbi.nlm.nih.gov

[Corneal Cross-linking for the treatment of keratoconus: preliminary results]. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

High-irradiance accelerated collagen crosslinking for the treatment of keratoconus: six-month results. [2022]

6. India pubmed.ncbi.nlm.nih.gov

Evaluation of changes in corneal volume, volume and angle of anterior chamber in keratoconus patients using Pentacam after CXL. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Induction of neoplasia after deep anterior lamellar keratoplasty in a CXL-treated cornea. [2022]

8. Switzerland 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. [2021]

9. India pubmed.ncbi.nlm.nih.gov

Topographic corneal changes after collagen cross-linking in patients with corneal keratoconus. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Current and future applications of corneal cross-linking. [2018]