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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01189864
Other study ID # CXL (12 & older)
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date February 1, 2010
Est. completion date February 3, 2017

Study information

Verified date September 2018
Source Cxlusa
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 3493
Est. completion date February 3, 2017
Est. primary completion date February 3, 2017
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ciprofloxicin or Vigamox or other.
Ciprofloxicin or Vigamox or other to be used qid till epithelialized.
Nonsteroidal (Acular, Acuvail, Voltaren Xibrom, etc)
Nonsteroidal (Acular, Voltaren Xibrom, etc) qid up to 5-10 days post-op
Steroid (FML, Pred Forte, Flarex, etc.)
Steroid (FML, Pred Forte, Flarex, etc.) to be used qid to qd for 1-8 weeks.

Locations

Country Name City State
United States Cleveland Eye Clinic Brecksville Ohio
United States TLC Laser Eye Center Fairfax Virginia
United States Chicago Cornea Consultants, LTD Hoffman Estates Illinois
United States Harvard Eye Associates Laguna Hills California
United States Corneal Consultants of Colorado, P.C Littleton Colorado
United States The Center for Excellence in Eye Care Miami Florida
United States TLC Laser Eye Center Rockville Maryland
United States Ophthalomology Associates Saint Louis Missouri
United States Clear View Eye & Laser Medical Center San Diego California
United States Schwartz Laser Eye Center Scottsdale Arizona
United States Northwest Eye Surgeons Seattle Washington
United States Empire Eye Physicians Spokane Valley Washington
United States Talamo Laser Eye Center Waltham Massachusetts
United States South Shore Eye Care LLP Wantagh New York
United States Davidorf Eye Group West Hills California

Sponsors (1)

Lead Sponsor Collaborator
Cxlusa

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within 1 year
Secondary increase the biomechanical and biochemical stability of the cornea between collagen fibers using UVA light and the photo- mediator riboflavin 1 year
See also
  Status Clinical Trial Phase
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Completed NCT01691651 - Botulinum Toxin A for the Treatment of Keratoconus N/A
Completed NCT01527708 - Accuracy of Curvature and Wavefront Aberrations of Posterior Corneal Surface, in Keratoconic and Post-CXL Corneas N/A
Completed NCT01527721 - Blurring Strength & Aberrometric Changes Following Corneal Cross-linking (CxL) and CxL Combined With Photorefractive Keratectomy (PRK) in Keratoconus N/A
Recruiting NCT00841386 - Treatment of Keratoconus Using Collagen Cross-Linking Phase 2/Phase 3
Completed NCT00347074 - A Clinical Study of Keratoconus in Asian Patients and Assessment of Different Topographic Patterns of Keratoconus in Asian Patients N/A
Completed NCT03187912 - Accelerated Corneal Cross-linking With Different Riboflavin Solutions Phase 3
Completed NCT00584285 - Corneal Topographer Fluorescein Patterns
Completed NCT03511495 - Reliability of Topography Measurements in Keratoconus
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Completed NCT04418999 - Safety and Efficacy of Intracanalicular Dexamethasone Compared to Loteprednol Etabonate in Patients With Keratoconus Early Phase 1
Completed NCT05019768 - Topo-pachimetric Accelerated Epi-On Cross-linking Compared to Dresden Protocol Using Riboflavin With Vitamin E TPGS N/A
Completed NCT03235856 - Retrospective Digital Computer Analysis of Keratoconus Evolution - REDCAKE
Withdrawn NCT01789333 - Higher Irradiance in Keratoconus Ectasia N/A
Completed NCT05114928 - Correlation Between Q-value Changes and Progression of Pediatric Keratoconus.
Completed NCT03647046 - Custom Anterior Surfacing of Scleral Lens for Vision Quality Improvement in Patients With Keratoconus N/A
Recruiting NCT04439552 - fMRI and IVCM Cornea Microscopy of CXL in Keratoconus
Recruiting NCT06100939 - Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age With Keratoconus Phase 3