McNeel Eye Center Corneal Crosslinking Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02921009|
Recruitment Status : Recruiting
First Posted : September 30, 2016
Last Update Posted : March 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Keratoconus||Device: Crosslinking using UV light of two different fluence rates||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Effectiveness and Safety of Transepithelial Collagen Cross-linking at Varying Fluence Levels.|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Crosslinking at different fluence rates
The study will investigate the effectiveness of Transepithelial riboflavin .25% treated with Ultraviolet light at fluence rates of 9mw/cm2 and 18mw/cm2 in the treatment of diagnosed keratoconus, pellucid marginal degeneration or post-LASIK ectasia.
Device: Crosslinking using UV light of two different fluence rates
The treatment of keratoconus involves the application of riboflavin followed by Ultraviolet light of differing intensities. This study will determine the effectiveness of a greater UV light fluence at a shorter treatment time than is currently utilized.
- Post treatment topographic analysis of Crosslinked patients [ Time Frame: One Year ]Pre-treatment videokeratography will be compared to post treatment keratography at certain intervals up to one year. Overall flattening of corneal curvature will be a primary study item.
- Post Treatment Best Corrected Visual Acuity [ Time Frame: One Year ]Best Corrected Visual acuity will be measured post treatment out to one year. Success will be determined by improvement in best corrected acuity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02921009
|Contact: Brian J McNeel, ODfirstname.lastname@example.org|
|Contact: Gregory J Kent, MDemail@example.com|
|United States, Idaho|
|McNeel Eye Center||Recruiting|
|Boise, Idaho, United States, 83713|
|Contact: Brian J McNeel, OD 208-938-2010 firstname.lastname@example.org|
|Contact: Gregory J Kent, MD 2083425151 email@example.com|
|Study Director:||Brian J McNeel, OD||McNeel Eye Center|
|Principal Investigator:||Gregory Kent, MD||The Eye Associates|