170 Participants Needed

Corneal Collagen Crosslinking for Keratoconus

(CXL Trial)

BF
SL
Overseen ByStacey Lazar
Age: Any Age
Sex: Any
Trial Phase: Phase 3
Sponsor: Cornea and Laser Eye Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This study is being conducted to evaluate the safety and efficacy of isotonic riboflavin for corneal collagen crosslinking for keratoconus and corneal ectasia. will determine the safety and efficacy of corneal collagen crosslinking (CXL) performed with two different riboflavin formulations for reducing corneal curvature.

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, it does mention that contact lens wearers need to stop wearing them for a week before screening.

What data supports the effectiveness of the treatment Riboflavin ophthalmic solution for keratoconus?

Research shows that using riboflavin with UV-A light in corneal collagen cross-linking helps improve vision and stabilize keratoconus, a condition where the cornea becomes thin and cone-shaped. This method is less invasive and addresses the root cause of the condition, making it effective in treating keratoconus.12345

Is corneal collagen crosslinking with riboflavin safe for humans?

Research studies have evaluated the safety of corneal collagen crosslinking using riboflavin for treating keratoconus, and they generally indicate that the procedure is safe for humans.16789

How is the treatment for keratoconus using riboflavin unique?

Corneal collagen crosslinking with riboflavin is unique because it strengthens the cornea by using a combination of riboflavin (Vitamin B2) and ultraviolet-A light, which helps to halt the progression of keratoconus, a condition where the cornea becomes thin and cone-shaped. This treatment is different from other options as it directly targets the structural integrity of the cornea rather than just correcting vision.810111213

Research Team

PS

Peter S Hersh, MD

Principal Investigator

Cornea and Laser Eye Institute Hersh Vision Group

SA

Steven A Greenstein, MD

Principal Investigator

Cornea and Laser Eye Institute, Hersh Vision Group

Eligibility Criteria

This trial is for people aged 12 or older with keratoconus or corneal ectasia, who can remove their contact lenses a week before testing and attend follow-up visits. Pregnant individuals, those with thin corneas, previous eye conditions that may cause complications, or sensitivity to study medications cannot participate.

Inclusion Criteria

My condition is related to a cone-shaped cornea or corneal thinning after surgery.
Presence of central or inferior steepening on the Pentacam map
I am 12 years old or older.
See 4 more

Exclusion Criteria

Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme
Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing
Pregnancy (including plan to become pregnant) or lactation during the course of the study
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive corneal collagen crosslinking using either riboflavin/dextran or riboflavin/methylcellulose solution with UVA light exposure

30 minutes
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with evaluations of maximum keratometry and visual acuity

12 months
Multiple visits (in-person)

Treatment Details

Interventions

  • Riboflavin
Trial OverviewThe trial tests the safety and effectiveness of two isotonic riboflavin solutions in reducing corneal curvature through corneal collagen crosslinking (CXL) in patients with keratoconus or post-surgical corneal ectasia.
Participant Groups
2Treatment groups
Active Control
Group I: CXL using Riboflavin/Dextran solutionActive Control1 Intervention
Corneal collagen crosslinking using 0.1% riboflavin mixed with 20% dextran
Group II: CXL usinng Riboflavin/Methylcellulose solutionActive Control1 Intervention
Corneal collagen crosslinking using 0.1% riboflavin mixed with 1.0% hydroxypropylmethylcellulose ( HPMC)

Riboflavin is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Riboflavin ophthalmic solution for:
  • Progressive keratoconus
  • Corneal ectasia following refractive surgery
🇪🇺
Approved in European Union as Riboflavin ophthalmic solution for:
  • Progressive keratoconus
  • Corneal ectasia following refractive surgery

Find a Clinic Near You

Who Is Running the Clinical Trial?

Cornea and Laser Eye Institute

Lead Sponsor

Trials
10
Recruited
1,100+

Findings from Research

Both the Sina Darou and Uznach formulations of Riboflavin were found to be equally effective in improving visual acuity and corneal topography in 60 keratoconus patients after 6 months of corneal collagen cross-linking (CXL).
The Sina Darou formulation resulted in a greater decrease in corneal hysteresis compared to the Uznach formulation, suggesting potential differences in their effects on corneal biomechanical properties, which will be further evaluated in long-term studies.
Comparison of clinical results of two pharmaceutical products of riboflavin in corneal collagen cross-linking for keratoconus.Hashemi, H., Seyedian, MA., Miraftab, M., et al.[2021]
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.
[Corneal Cross-linking for the treatment of keratoconus: preliminary results].Jankov, MR., Hafezi, F., Beko, M., et al.[2019]
In a long-term study of 44 keratoconic eyes treated with riboflavin ultraviolet A collagen cross-linking, the procedure demonstrated significant stability of keratoconus over an average follow-up of 52.4 months, with no major side effects reported.
Patients experienced notable improvements in visual acuity, with an average increase of 1.9 Snellen lines for best spectacle-corrected vision and 2.7 lines for uncorrected vision, alongside reductions in corneal irregularities and aberrations.
Long-term results of riboflavin ultraviolet a corneal collagen cross-linking for keratoconus in Italy: the Siena eye cross study.Caporossi, A., Mazzotta, C., Baiocchi, S., et al.[2022]

References

Comparison of clinical results of two pharmaceutical products of riboflavin in corneal collagen cross-linking for keratoconus. [2021]
[Corneal Cross-linking for the treatment of keratoconus: preliminary results]. [2019]
Long-term results of riboflavin ultraviolet a corneal collagen cross-linking for keratoconus in Italy: the Siena eye cross study. [2022]
Long-term results of corneal collagen crosslinking for progressive keratoconus. [2022]
Collagen cross-linking with riboflavin and ultraviolet-A light in keratoconus: One-year results. [2022]
A Prospective, Comparative, Clinical Study to Evaluate the Safety and Efficacy of Two Different 0.1% Riboflavin Solutions Used in Collagen Crosslinking Treatment for Patients with Keratoconus. [2022]
[Corneal collagen cross-linking in the treatment of progressive keratoconus-preliminary results]. [2014]
Effect of inferior-segment Intacs with and without C3-R on keratoconus. [2022]
Riboflavin/Ultraviolet A corneal collagen cross-linking for the treatment of keratoconus: visual outcomes and Scheimpflug analysis. [2022]
Long-term visual, refractive, tomographic and aberrometric outcomes of corneal collagen crosslinking (CXL) with or without hypoosmolar riboflavin solution in the treatment of progressive keratoconus patients with thin corneas. [2022]
Six-month outcomes of corneal crosslinking with dextran-free isotonic riboflavin solution. [2017]
12.United Statespubmed.ncbi.nlm.nih.gov
High-irradiance accelerated collagen crosslinking for the treatment of keratoconus: six-month results. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Safety profile of high-fluence corneal collagen cross-linking for progressive keratoconus: preliminary results from a prospective cohort study. [2022]