A Phase 3 interventional study of Epithelium-On Riboflavin and Epithelium-Off Riboflavin in Unstable Corneas, sponsored by Crowd Health Research, LTD. Status unknown at 16 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2014-03-26.
Sponsored by Crowd Health Research, LTD · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the Safety and Efficacy of Corneal Cross Linking in a Continuous Beam versus Pulsed Treatments across epithelium on and epithelium off surfaces.
130 studies on the registry are indexed under Corneal Diseases; 43 are open to participants now.
This study's planned enrollment of 500 is above the median of 32 across 78 interventional studies indexed under Corneal Diseases.
Browse Corneal Diseases studies →This is the only study on the registry with Crowd Health Research, LTD as lead sponsor.
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Inclusion Criteria Keratoconus:
Having a clinical diagnosis of progressive keratoconus consistent with:
Inclusion Criteria Post-Surgical Ectasia:
History of having undergone a keratorefractive procedure and:
Inclusion Criteria Intacts:
Should the patient have undergone prior Intacs or other intra-corneal ring segment surgery for keratoconus or post-surgical ectasia at least 6 months prior, and is also experiencing at least two of the above ectasia symptoms, they can be included in the study.
Inclusion Criteria RK/AK Fluctuation:
Exclusion Criteria:
Continuous beam of UV light treating cornea with surface epithelium present
Drug: Epithelium-On Riboflavin · Device: UV Light - Continuous Beam
Continuous beam of UV light treating cornea without surface epithelium present
Drug: Epithelium-Off Riboflavin · Device: UV Light - Continuous Beam
Pulsed beam of UV light treating cornea with surface epithelium present
Drug: Epithelium-On Riboflavin · Device: UV Pulsed Beam
Pulsed beam of UV light treating cornea without surface epithelium present
Drug: Epithelium-Off Riboflavin · Device: UV Pulsed Beam
Riboflavin 0.1% Phosphate Sodium solution with Benzalkonium Chloride Preservative
Also known as: Vitamin B2
Riboflavin 0.1% Phosphate Sodium solution
Also known as: Vitamin B2
5 minutes of constant UV exposure to saturated cornea
Also known as: Peschke Vario CCL-365 UV system
5 minutes of UV exposure to saturated cornea, alternating 1 minute of treatment with 1 minute rest for a total time of 10 minutes
Also known as: Peschke Vario CCL-365 UV system
Visual Acuity
Uncorrected visual acuity
Time frame: 2 years
This study is status unknown, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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