Clinical Trial: Study of the Safety and Effectiveness of Photochemically Induced Collagen Cross-Linking in Eyes With Keratoconus.

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Study of the Safety and Effectiveness of Photochemically Induced Collagen Cross-Linking at an Irrandiance of 18 mW/cm2 in Eyes With Keratoconus or Ectasia.

Brief Summary: This study is being conducted to assess the safety and effectiveness of photochemically induced collagen cross- linking (CCL) at irradiance of 18mW/cm2 in eyes with Keratoconus and Ecstasia.

Detailed Summary: Riboflavin drops are used every 2 minutes for 30+ minutes until the corneal stroma is saturated with Riboflavin as evidenced by observing Riboflavin in the Anterior chamber. Two arms in the study, one uses Riboflavin with Epithelium on and the other with Epithelium off. Once it is observed that the Riboflavin has penetrated the stroma and is seen in the anterior chamber, the cornea is exposed to Ultraviolet light at an irradiance level of 18mW/cm2 for 5 minutes. A contact lens is applied until the epithelium has fully healed in 3 to 5 days. The study is for 6 months. The corneal curvature as well as the uncorrected and best corrected vision and corneal thickness are evaluated pre-operatively and at 6 months. The primary variable that is assessed to determine the efficacy of the drug is the Kmax - Steep corneal curvature. Secondary effectiveness criteria are uncorrected and best corrected vision and corneal thickness. adverse events are also monitored.
Sponsor: Nvision Laser Eye Centers

Current Primary Outcome: Keratometry [ Time Frame: 6 months ]

The change in maximum keratometry (Kmax) from baseline will be evaluated at 6 months for all eyes. Data will be summarized using descriptive statistics.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • manifest refraction [ Time Frame: 6 months ]
    The change in manifest refraction at 6 months compared to pre op
  • Visual Acuity [ Time Frame: 6 months ]
    Change in BSCVA and UCVA compared to the baseline examination will be evaluated at 6 months postoperatively.
  • Central Pachymetry [ Time Frame: 6 months ]
    The change in central pachymetry (as measured by Pentacam) from baseline will be evaluated at 6 months postoperatively. Data will be summarized using descriptive statistics.


Original Secondary Outcome: Same as current

Information By: Nvision Laser Eye Centers

Dates:
Date Received: May 3, 2016
Date Started: September 2012
Date Completion:
Last Updated: May 4, 2016
Last Verified: May 2016