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Corneal Collagen Crosslinking for Keratoconus and Ectasia Using Riboflavin/Dextran or Riboflavin/Methylcellulose

Phase 3
Recruiting
Conditions
Keratoconus
Corneal Ectasia
Interventions
Registration Number
NCT04897503
Lead Sponsor
Cornea and Laser Eye Institute
Brief Summary

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.

Detailed Description

This study will determine the safety and efficacy of corneal collagen crosslinking (CXL) performed with two different riboflavin formulations for reducing corneal curvature. Subjects will be randomized to one of 2 groups. One group will be treated with a methylcellulose riboflavin solution and the other group will be treated with a dextran riboflavin solution. Both groups will be exposed to 3mW/cm2 of continuous UVA light for a total of 30 minutes; each group will continue to be administered the designated riboflavin drops during UV exposure.

The primary efficacy parameter that will be evaluated over time is maximum keratometry (Kmax) in the randomized eyes for each treatment group.

The secondary efficacy parameter will be to determine if the two treatment groups equivalent in their Kmax change at 12 months after treatment compared with baseline.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
170
Inclusion Criteria
  • 12 years of age or older
  • Having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery
  • Presence of central or inferior steepening on the Pentacam map
  • Axial topography consistent with keratoconus or post-surgical corneal ectasia
  • Contact lens wearers only: removal of contact lens for the required period of 1 week prior to the screening refraction
  • Signed written informed consent
  • Willingness and ability to comply with schedule for follow-up visits
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Exclusion Criteria
  • Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme
  • Corneal pachymetry less than or equal to 300 microns at the thinnest point measured by Pentacam 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 corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.) Clinically significant corneal scarring in the CXL treatment zone
  • A history of chemical injury or delayed epithelial healing in the eye(s) to be treated
  • 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 a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
CXL using Riboflavin/Dextran solutionRiboflavinCorneal collagen crosslinking using 0.1% riboflavin mixed with 20% dextran
CXL usinng Riboflavin/Methylcellulose solutionRiboflavinCorneal collagen crosslinking using 0.1% riboflavin mixed with 1.0% hydroxypropylmethylcellulose ( HPMC)
Primary Outcome Measures
NameTimeMethod
Maximum keratometry12 months

The change in maximum keratometry (Kmax) from baseline will be evaluated at 12 months for all eyes randomized in group 1 and group 2.

Secondary Outcome Measures
NameTimeMethod
Visual acuity1 year

Change in uncorrected visual acuity (UCVA) and best spectacle corrected visual acuity (BCVA) compared to the baseline examination will be evaluated at 12 months postoperatively.

Trial Locations

Locations (1)

Cornea and Laser Eye Institue - Hersh Vision Group

🇺🇸

Teaneck, New Jersey, United States

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