Comparison of Standard vs. Accelerated Corneal Crosslinking
July 28, 2025 updated by: Price Vision Group
Randomized Comparison of Standard vs. Accelerated Corneal Crosslinking for Treatment of Progressive Keratoconus or Ectasia
The study objective is to compare accelerated and standard corneal crosslinking for treatment of progressive keratoconus or corneal ectasia.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
510
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marianne Price, PhD
- Phone Number: 317-814-2990
- Email: mprice@cornea.org
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46260
- Recruiting
- Price Vision Group
-
Contact:
- Marianne Price, Ph.D
- Phone Number: 317-814-2990
- Email: marianneprice@cornea.org
-
Principal Investigator:
- Francis Price, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Accelerated
Treatment with 0.1% riboflavin eye drops and 9 mW/cm2 UVA light for 10 minutes
|
Use of riboflavin 0.1% eye drops and 9 mW/cm2 UVA light for 10 minutes
|
|
Active Comparator: Standard
Treatment with 0.1% riboflavin eye drops and 3 mW/cm2 UVA light for 30 minutes
|
Use of riboflavin 0.1% eye drops and 3 mW/cm2 UVA light for 30 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in maximum keratometry
Time Frame: 6 months
|
assessed by corneal tomography
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in corrected distance visual acuity
Time Frame: 6 months
|
assessed with Snellen chart
|
6 months
|
|
Change in uncorrected distance visual acuity
Time Frame: 6 months
|
assessed with Snellen chart
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Francis W Price, Jr., MD, Price Vision Group
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 16, 2019
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
July 1, 2026
Study Registration Dates
First Submitted
April 17, 2019
First Submitted That Met QC Criteria
April 19, 2019
First Posted (Actual)
April 22, 2019
Study Record Updates
Last Update Posted (Actual)
July 31, 2025
Last Update Submitted That Met QC Criteria
July 28, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.