Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to determine the effectiveness of collagen cross-linking in the cornea in halting the progression and possibly partially reversing the effects of keratoconus. Keratoconus is a progressive weakening in the cornea that causes irregular astigmatism and thinning of the cornea. The overall effect is reduction of vision, and in more advanced cases, scarring of the cornea that may lead to the need for corneal transplantation. Cross-linking has been shown increase the rigidity of the cornea. The patients would be treated once and then followed over 24 months. .


Clinical Trial Description

The goal is for two groups of approximately 66 patients to be included in the study. One eye from the first group will undergo treatment, while the second group of age matched individuals will serve as a control. It will be a prospective, randomized, blinded study. Each patient will be randomized at the beginning of enrollment in the study and will receive a randomization number. The following parameters will be followed: 1. Best corrected spectacle acuity (BCSA) 2. The steepest keratometry measurement (KMax) as measured by computerized corneal topography 3. Apical corneal thickness 4. Corneal mechanical resistance. These measurements will be repeated at 1 month, 3 months, 6 months, 12, 18, and 24 months following treatment. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00841386
Study type Interventional
Source University at Buffalo
Contact James J. Reidy, M.D.
Phone 716-881-7920
Email jreidymd@mac.com
Status Recruiting
Phase Phase 2/Phase 3
Start date September 2008
Completion date December 2011

See also
  Status Clinical Trial Phase
Recruiting NCT04570020 - Scleral Lens Fitting Using Wide-Field OCT
Recruiting NCT02921009 - McNeel Eye Center Corneal Crosslinking Study N/A
Completed NCT01691651 - Botulinum Toxin A for the Treatment of Keratoconus N/A
Terminated NCT02762253 - Study of the Safety and Effectiveness of Photochemically Induced Collagen Cross-Linking in Eyes With Keratoconus. Phase 2
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
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
Not yet recruiting NCT05395650 - Cyanocobalamin as Photosensitizing Agent
Completed NCT04418999 - Safety and Efficacy of Intracanalicular Dexamethasone Compared to Loteprednol Etabonate in Patients With Keratoconus Early Phase 1
Completed NCT03235856 - Retrospective Digital Computer Analysis of Keratoconus Evolution - REDCAKE
Completed NCT05019768 - Topo-pachimetric Accelerated Epi-On Cross-linking Compared to Dresden Protocol Using Riboflavin With Vitamin E TPGS N/A
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
Completed NCT02444923 - Scleral Versus Corneal RGP Contact Lenses in Irregular Cornea Disorders N/A