Comparison of Standard vs. Accelerated Corneal Crosslinking
Randomized Comparison of Standard vs. Accelerated Corneal Crosslinking for Treatment of Progressive Keratoconus or Ectasia
1 other identifier
interventional
510
1 country
1
Brief Summary
The study objective is to compare accelerated and standard corneal crosslinking for treatment of progressive keratoconus or corneal ectasia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2019
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 16, 2019
CompletedFirst Submitted
Initial submission to the registry
April 17, 2019
CompletedFirst Posted
Study publicly available on registry
April 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
July 31, 2025
July 1, 2025
7.1 years
April 17, 2019
July 28, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change in maximum keratometry
assessed by corneal tomography
6 months
Secondary Outcomes (2)
Change in corrected distance visual acuity
6 months
Change in uncorrected distance visual acuity
6 months
Study Arms (2)
Accelerated
ACTIVE COMPARATORTreatment with 0.1% riboflavin eye drops and 9 mW/cm2 UVA light for 10 minutes
Standard
ACTIVE COMPARATORTreatment with 0.1% riboflavin eye drops and 3 mW/cm2 UVA light for 30 minutes
Interventions
Use of riboflavin 0.1% eye drops and 9 mW/cm2 UVA light for 10 minutes
Eligibility Criteria
You may qualify if:
- Documented keratoconus or ectasia after refractive surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Price Vision Group
Indianapolis, Indiana, 46260, United States
Related Publications (3)
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.
PMID: 29203068BACKGROUNDLautert 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.
PMID: 29889294BACKGROUNDPrice 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.
PMID: 29605283BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francis W Price, Jr., MD
Price Vision Group
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2019
First Posted
April 22, 2019
Study Start
April 16, 2019
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
July 31, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share