Clinical Trial: Higher Irradiance in Keratoconus Ectasia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Study of the Safety and Effectiveness of Photochemically Induced Collagen Cross- Linking at Higher Irradiances in Patients With Keratoconus or Ectasia

Brief Summary: The purpose of the study is to see if brighter lights will allow for shortening of the treatment time required to stabilize the eyes of patients with keratoconus or a bulging cornea. The investigators will be comparing the therapeutic effects of two different higher brightnesses of ultra violet light on a riboflavin treated eye. One light will be twice as bright as the other and the exposure time of these brighter lights to deliver equivalent energy to the cornea will be reduced from the standard 30 minutes to 10 and 5 minutes. Riboflavin is vitamin B2 and the investigators are trying to determine if an identical clinical effect can be achieved the brighter treatment lights are used for shorter times. The investigators will also monitor the clinical effect and the status of the cornea to see if additional risks are associated with the brighter light.

Detailed Summary:
Sponsor: Stephen Trokel

Current Primary Outcome: Change in Total Optical Aberrations of the Cornea following Cross-Linking [ Time Frame: Baseline to 6 months ]

The change in corneal topography and optical properties from baseline will be evaluated at 3 and 6 months for all eyes.


Original Primary Outcome: Change in Total Higher Order Aberrations of the Cornea [ Time Frame: Baseline and 6 months ]

The change in corneal topography and optical properties from baseline will be evaluated at 3 and 6 months for all eyes.


Current Secondary Outcome:

  • Change in Uncorrected Visual Acuity (UCVA) [ Time Frame: Baseline to 6 months ]
  • Change in Best Spectacle Corrected Visual Acuity (BSCVA) [ Time Frame: Baseline to 6 months ]
  • Change in Manifest Refraction [ Time Frame: Baseline and 6 months ]


Original Secondary Outcome:

  • Change in Uncorrected Visual Acuity (UCVA) [ Time Frame: Baseline and 6 months ]
  • Change in Best Spectacle Corrected Visual Acuity (BSCVA) [ Time Frame: Baseline and 6 months ]
  • Change in Manifest Refraction [ Time Frame: Baseline and 6 months ]


Information By: Columbia University

Dates:
Date Received: November 20, 2012
Date Started: August 2010
Date Completion: August 2017
Last Updated: July 28, 2016
Last Verified: July 2016