Cross-linking of Corneal Collagen (CXL) With Ultraviolet-A in Asymmetric Corneas

Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01189864

Enrollment

3493

Registered

2010-08-27

Start date

2010-02-01

Completion date

2017-02-03

Last updated

2018-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degeneration, Ectasia, Keratoconus

Brief summary

The purpose of this study is to evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) as a method to increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within or between collagen fibers using UVA light and the photo- mediator riboflavin. The purpose of this study is to generate data for presentation at medical meetings and for peer-review publication. The data generated by this study will not be submitted to the FDA to support commercialization of these riboflavin drops.

Interventions

DRUGCiprofloxicin or Vigamox or other.

Ciprofloxicin or Vigamox or other to be used qid till epithelialized.

DRUGNonsteroidal (Acular, Acuvail, Voltaren Xibrom, etc)

Nonsteroidal (Acular, Voltaren Xibrom, etc) qid up to 5-10 days post-op

DRUGSteroid (FML, Pred Forte, Flarex, etc.)

Steroid (FML, Pred Forte, Flarex, etc.) to be used qid to qd for 1-8 weeks.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Inclusion criteria

* 12 years of age or older * Diagnosis of keratoconus, FFKC, post-LASIK ectasia, or pellucid marginal degeneration or forme fruste pellucid marginal degeneration (FFPMD). * Diagnosis of FFKC * History of Radial Keratotomy with fluctuating vision * Ability to provide written informed consent * Likely to complete all study visits * Minimum corneal thickness of at least 300 Measured by ultrasound or Pentacam * At least 6 months since last corneal surgery (Intacs/PRK/LASIK/Epi-LASIK/LASEK)

Exclusion criteria

* Severe corneal scarring that markedly affects vision * Contraindications to any study medications or their components * Pregnancy or breast feeding * Active Herpes Corneal Disease

Design outcomes

Primary

Measure	Time frame
Increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within	1 year

Secondary

Measure	Time frame
increase the biomechanical and biochemical stability of the cornea between collagen fibers using UVA light and the photo- mediator riboflavin	1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026