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McNeel Eye Center Corneal Crosslinking Study

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ClinicalTrials.gov Identifier: NCT02921009
Recruitment Status : Recruiting
First Posted : September 30, 2016
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Brian J. McNeel, McNeel Eye Center

Brief Summary:
This study will investigate the effectiveness in treating keratoconus, pellucid marginal degeneration and post LASIK iatrogenic ectasia utilizing fluence rates and treatment times of Corneal Cross Linking other than the original FDA approved protocol of 3mw/cm2.

Condition or disease Intervention/treatment Phase
Keratoconus Device: Crosslinking using UV light of two different fluence rates Not Applicable

Detailed Description:
Patient recruitment will include a patient population of 100 individuals from 15 years to 50 years old with established keratoconus, pellucid marginal degeneration or post-LASIK ectasia determined by keratography. A solution of transepithelial riboflavin .25% will be applied every three minutes for 30 minutes or until complete corneal penetration is observed. Then the cornea will be irradiated with UV light at fluence rates of 9mw/cm2 for 10 minutes or 18 mw/cm2 for 5 minutes. Post procedural evaluation will take place at day one, day 7 day 30, day 90, day 180 and day 365. Pretreatment keratography, uncorrected acuity, best corrected acuity will be compared at follow up days beginning on day 30.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males or females between the ages of 15 and 50 with keratoconus diagnosed topographically with or without other corneal ectatic disease.

Exclusion Criteria:

  • Prior corneal transplantation, pregnancy, inability or unwillingness to adhere to follow up protocol.

Information from the National Library of Medicine

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


Contacts
Contact: Brian J McNeel, OD 2089382010 bjmcneelod@yahoo.com
Contact: Gregory J Kent, MD 2083425151 gjkent6@hotmail.com

Locations
United States, Idaho
McNeel Eye Center Recruiting
Boise, Idaho, United States, 83713
Contact: Brian J McNeel, OD    208-938-2010    bjmcneelod@yahoo.com   
Contact: Gregory J Kent, MD    2083425151    gjkent6@hotmail.com   
Sponsors and Collaborators
McNeel Eye Center
Investigators
Study Director: Brian J McNeel, OD McNeel Eye Center
Principal Investigator: Gregory Kent, MD The Eye Associates

Responsible Party: Brian J. McNeel, O.D., F.A.A.O., McNeel Eye Center
ClinicalTrials.gov Identifier: NCT02921009     History of Changes
Other Study ID Numbers: MEC CxL Transepithelial
First Posted: September 30, 2016    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared with ophthalmic community once a total of 50 eyes have been completed.
Supporting Materials: Study Protocol
Time Frame: Within 90 days of the completion of the study, anticipated to be in December of 2018.
Access Criteria: Via email - bjmcneelod@yahoo.com

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases