Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01024322

Enrollment

1189

Registered

2009-12-02

Start date

2009-10-01

Completion date

2017-02-03

Last updated

2018-10-11

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

Conditions

Degeneration, Ectasia, Keratoconus

Keywords

Diagnosis of keratoconus, post-LASIK ectasia, FFKC, or pellucid marginal degeneration

Brief summary

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

Interventions

DRUGCiprofloxicine or Vigamox or other.

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

DRUGNonsteroidal (Acular, Voltaren Xibrom, etc)

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

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

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

8 Years to No maximum

Healthy volunteers

Inclusion criteria

* 8 years of age or older * Diagnosis of keratoconus, post-LASIK ectasia, or pellucid marginal degeneration or forme fruste pellucid marginal degeneration. * Diagnosis of FFKC * History of Radial Keratotomy with fluctuating vision. * Terrien's Marginal Degeneration * Ability to provide written informed consent * Likely to complete all study visits * Minimum corneal thickness of at least 300 250 microns measured by ultrasound or Pentacam for all indications other than Terriens. For Terriens, the minimal corneal thickness should be consistent with the surgeon's best surgical judgment.

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