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NCT01097447 Clinical Trial

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

Keratoconus Clinical Trial

Official title:
Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01097447
Other study ID # CXL (2)
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date December 1, 2009
Est. completion date April 30, 2017

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

Clinical Trial 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

Recruitment information / eligibility
Status Terminated
Enrollment 2619
Est. completion date April 30, 2017
Est. primary completion date April 30, 2017
Accepts healthy volunteers No
Gender All
Age group 8 Years and older
Eligibility 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:

- 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

Locations
Country Name City State
United States Minnesota Eye Consultants, P.A. Bloomington Minnesota
United States Cornea Associates of Texas Dallas Texas
United States Chicago Cornea Consultants, LTD Hoffman Estates Illinois
United States Corneal Consultants of Colorado, P.C Littleton Colorado
United States Clear View Eye & Laser Medical Center San Diego 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
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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
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Completed NCT03187912 - Accelerated Corneal Cross-linking With Different Riboflavin Solutions Phase 3
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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