Back to resultsComparison of Standard vs. Accelerated Corneal Crosslinking
Primary Purpose
Keratoconus, Ectasia Corneal
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
riboflavin 0.1%
Riboflavin 0.1%
Sponsored by
About this trial
This is an interventional treatment trial for Keratoconus
Eligibility Criteria
Inclusion Criteria:
- Documented keratoconus or ectasia after refractive surgery
Exclusion Criteria:
- Insufficient corneal thickness
- Ocular condition that may predispose the eye to complications
- History of chemical injury or delayed epithelial healing
- Condition that would interfere with or prolong epithelial healing
- Known sensitivity to treatment medications
- Pregnancy
Sites / Locations
- Price Vision GroupRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Accelerated
Standard
Arm Description
Treatment with 0.1% riboflavin eye drops and 9 mW/cm2 UVA light for 10 minutes
Treatment with 0.1% riboflavin eye drops and 3 mW/cm2 UVA light for 30 minutes
Outcomes
Primary Outcome Measures
Change in maximum keratometry
assessed by corneal tomography
Secondary Outcome Measures
Change in corrected distance visual acuity
assessed with Snellen chart
Change in uncorrected distance visual acuity
assessed with Snellen chart
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03922542
Brief Title
Comparison of Standard vs. Accelerated Corneal Crosslinking
Official Title
Randomized Comparison of Standard vs. Accelerated Corneal Crosslinking for Treatment of Progressive Keratoconus or Ectasia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 16, 2019 (Actual)
Primary Completion Date
May 1, 2026 (Anticipated)
Study Completion Date
May 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Price Vision Group
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study objective is to compare accelerated and standard corneal crosslinking for treatment of progressive keratoconus or corneal ectasia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus, Ectasia Corneal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
510 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Accelerated
Arm Type
Active Comparator
Arm Description
Treatment with 0.1% riboflavin eye drops and 9 mW/cm2 UVA light for 10 minutes
Arm Title
Standard
Arm Type
Active Comparator
Arm Description
Treatment with 0.1% riboflavin eye drops and 3 mW/cm2 UVA light for 30 minutes
Intervention Type
Combination Product
Intervention Name(s)
riboflavin 0.1%
Intervention Description
Use of riboflavin 0.1% eye drops and 9 mW/cm2 UVA light for 10 minutes
Intervention Type
Combination Product
Intervention Name(s)
Riboflavin 0.1%
Intervention Description
Use of riboflavin 0.1% eye drops and 3 mW/cm2 UVA light for 30 minutes
Primary Outcome Measure Information:
Title
Change in maximum keratometry
Description
assessed by corneal tomography
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in corrected distance visual acuity
Description
assessed with Snellen chart
Time Frame
6 months
Title
Change in uncorrected distance visual acuity
Description
assessed with Snellen chart
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Documented keratoconus or ectasia after refractive surgery
Exclusion Criteria:
Insufficient corneal thickness
Ocular condition that may predispose the eye to complications
History of chemical injury or delayed epithelial healing
Condition that would interfere with or prolong epithelial healing
Known sensitivity to treatment medications
Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marianne Price, PhD
Phone
317-814-2990
Email
mprice@cornea.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis W Price, Jr., MD
Organizational Affiliation
Price Vision Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Price Vision Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marianne Price, Ph.D
Phone
317-814-2990
Email
marianneprice@cornea.org
First Name & Middle Initial & Last Name & Degree
Francis Price, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29203068
Citation
Price MO, Fairchild K, Feng MT, Price FW Jr. Prospective Randomized Trial of Corneal Cross-linking Riboflavin Dosing Frequencies for Treatment of Keratoconus and Corneal Ectasia. Ophthalmology. 2018 Apr;125(4):505-511. doi: 10.1016/j.ophtha.2017.10.034. Epub 2017 Dec 2.
Results Reference
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PubMed Identifier
29889294
Citation
Lautert J, Doshi D, Price FW Jr, Price MO. Corneal Epithelial Remodeling After Standard Epithelium-off Corneal Cross-linking in Keratoconic Eyes. J Refract Surg. 2018 Jun 1;34(6):408-412. doi: 10.3928/1081597X-20180402-03.
Results Reference
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PubMed Identifier
29605283
Citation
Price MO, Feng MT, Price FW Jr. Patient satisfaction with epithelium-off corneal crosslinking. J Cataract Refract Surg. 2018 Mar;44(3):323-328. doi: 10.1016/j.jcrs.2017.12.023. Epub 2018 Mar 28.
Results Reference
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Learn more about this trial
Comparison of Standard vs. Accelerated Corneal Crosslinking
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