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McNeel Eye Center Corneal Crosslinking Study

Primary Purpose

Keratoconus

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Crosslinking using UV light of two different fluence rates
Sponsored by
McNeel Eye Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus

Eligibility Criteria

15 Years - 50 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • McNeel Eye CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Crosslinking at different fluence rates

Arm Description

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.

Outcomes

Primary Outcome Measures

Post treatment topographic analysis of Crosslinked patients
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

Post Treatment Best Corrected Visual Acuity
Best Corrected Visual acuity will be measured post treatment out to one year. Success will be determined by improvement in best corrected acuity.

Full Information

First Posted
September 29, 2016
Last Updated
September 14, 2022
Sponsor
McNeel Eye Center
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1. Study Identification

Unique Protocol Identification Number
NCT02921009
Brief Title
McNeel Eye Center Corneal Crosslinking Study
Official Title
Study of Effectiveness and Safety of Transepithelial Collagen Cross-linking at Varying Fluence Levels.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 2016 (undefined)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McNeel Eye Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Crosslinking at different fluence rates
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Crosslinking using UV light of two different fluence rates
Intervention Description
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 Measure Information:
Title
Post treatment topographic analysis of Crosslinked patients
Description
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.
Time Frame
One Year
Secondary Outcome Measure Information:
Title
Post Treatment Best Corrected Visual Acuity
Description
Best Corrected Visual acuity will be measured post treatment out to one year. Success will be determined by improvement in best corrected acuity.
Time Frame
One Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian J McNeel, OD
Phone
2089382010
Email
bjmcneelod@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gregory J Kent, MD
Phone
2083425151
Email
gjkent6@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian J McNeel, OD
Organizational Affiliation
McNeel Eye Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gregory Kent, MD
Organizational Affiliation
The Eye Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
McNeel Eye Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83713
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian J McNeel, OD
Phone
208-938-2010
Email
bjmcneelod@yahoo.com
First Name & Middle Initial & Last Name & Degree
Gregory J Kent, MD
Phone
2083425151
Email
gjkent6@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared with ophthalmic community once a total of 50 eyes have been completed.
IPD Sharing Time Frame
Within 90 days of the completion of the study, anticipated to be in December of 2018.
IPD Sharing Access Criteria
Via email - bjmcneelod@yahoo.com

Learn more about this trial

McNeel Eye Center Corneal Crosslinking Study

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