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TerminatedNCT01097447Updated Oct 11, 2018

Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas (2)

An observational study in Keratoconus, Ectasia and Degeneration, sponsored by Cxlusa. Terminated at 5 sites in United States. Open to participants aged 8 Years and older. Per ClinicalTrials.gov, last updated 2018-10-11.

Sponsored by Cxlusa · Observational

Why this study was terminated
Terminated to initiate FDA IND-cleared study protocol
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,619
Ages
8 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Keratoconus
  • Ectasia
  • Degeneration

Keywords

  • Diagnosis of keratoconus, post-LASIK ectasia, FFKC, or pellucid marginal degeneration
03

In context

Keratoconus

307 studies on the registry are indexed under Keratoconus; 56 are open to participants now.

This study's enrollment of 2,619 is above the median of 130 across 94 observational studies indexed under Keratoconus.

Browse Keratoconus studies →

Lead sponsor

Cxlusa is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Primary care clinic

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.
  • Ability to provide written informed consent
  • Likely to complete all study visits
  • Minimum corneal thickness of at least 300 measured by ultrasound or Pentacam

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,619 participants (actual)

Groups and cohorts

  • Ciprofloxicine or Vigamox or other

    up to qid till epithelialized.

  • Topical Nonsteroidal (Acular, Acuvail, Voltaren Xibrom

    up to qid for up to 5-10 days postop

  • Topical steroid (FML, Pred Forte, Flarex

    qid for up to 8 weeks

06

What researchers measure

Primary outcomes

  1. Increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within

    Time frame: 1 year

Secondary outcomes

  1. increase the biomechanical and biochemical stability of the cornea between collagen fibers using UVA light and the photo- mediator riboflavin

    Time frame: 1 year

07

Study locations

5 sites
  • Clear View Eye & Laser Medical Center
    San Diego, California 92121, United States
  • Corneal Consultants of Colorado, P.C
    Littleton, Colorado, United States
  • Chicago Cornea Consultants, LTD
    Hoffman Estates, Illinois, United States
  • Minnesota Eye Consultants, P.A.
    Bloomington, Minnesota 55431, United States
  • Cornea Associates of Texas
    Dallas, Texas 75231, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 11, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01097447
Lead sponsor
Cxlusa
Responsible party
Sponsor
First posted
Apr 1, 2010
Start date
Dec 1, 2009
Primary completion
Apr 30, 2017
Completion
Apr 30, 2017
Last update
Oct 11, 2018

Study contacts

Parag Majmudar, MD
principal investigator · Chicago Cornea Consultants, LTD
Lance Forstot, MD
principal investigator · Corneal Consultants of Colorado, P.C
Bradley Bowman, M.D
principal investigator · Cornea Associates of Texas
Sandy Feldman, M.D
principal investigator · Clear View Eye & Laser Medical Center
Sherman Reeves, MD
principal investigator · Minnesota Eye Consultants, P.A.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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