Prospective Randomized Trial of Corneal Cross-linking Riboflavin Dosing Frequencies for Treatment of Keratoconus and Corneal Ectasia.
Marianne O Price, Kelly Fairchild, Matthew T Feng...
https://pubmed.ncbi.nlm.nih.gov/29203068Actively Recruiting
Phase 2
Phase 3
Age: 10Years +
All Genders
ID03922542
Randomized Comparison of Standard vs. Accelerated Corneal Crosslinking for Treatment of Progressive Keratoconus or Ectasia
Led by Price Vision Group · Updated on 2025-07-31
510
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two methods of corneal crosslinking to treat progressive keratoconus or corneal ectasia, conditions that affect the shape and strength of the cornea. This study evaluates accelerated versus standard treatment to understand which approach better manages these eye conditions. The trial is conducted by the Price Vision Group and includes participants aged 10 years and older. Participants receive one of two treatments: either 0.1% riboflavin eye drops with 9 mW/cm2 UVA light for 10 minutes (accelerated), or 0.1% riboflavin eye drops with 3 mW/cm2 UVA light for 30 minutes (standard). These treatments aim to strengthen the cornea using different light intensities and durations. The study randomly assigns participants to one of these two groups. During the study, researchers measure changes in the maximum keratometry, which assesses corneal curvature, at 6 months. They also track changes in both corrected and uncorrected distance visual acuity over the same period. Participants undergo eye examinations and monitoring to assess treatment effects and safety throughout the study.
CONDITIONS
Brief Title
Comparison of Standard vs. Accelerated Corneal Crosslinking
Who Can Participate
Age: 10Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Documented keratoconus or ectasia after refractive surgery
- Age 10 years or older
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single treatment session
Participants receive treatment with 0.1% riboflavin eye drops and UVA light, either 9 mW/cm2 for 10 minutes or 3 mW/cm2 for 30 minutes, depending on their assigned group.
1 treatment visit
Follow-up
Duration - 6 months
Participants are monitored for changes in corneal condition and visual acuity after treatment.
Periodic visits during 6 months post-treatment
Trial Site Locations
Total: 1 location
1
Price Vision Group
Indianapolis, Indiana, United States, 46260
Actively Recruiting
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Research Team
M
Marianne Price, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Corneal Epithelial Remodeling After Standard Epithelium-off Corneal Cross-linking in Keratoconic Eyes.
Jeferson Lautert, Dharmil Doshi, Francis W Price...
https://pubmed.ncbi.nlm.nih.gov/29889294Patient satisfaction with epithelium-off corneal crosslinking.
Marianne O Price, Matthew T Feng, Francis W Price
https://pubmed.ncbi.nlm.nih.gov/29605283