Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
500 participants
INTERVENTIONAL
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Epi-On Continuous
Continuous beam of UV light treating cornea with surface epithelium present
Epithelium-On Riboflavin
Riboflavin 0.1% Phosphate Sodium solution with Benzalkonium Chloride Preservative
UV Light - Continuous Beam
5 minutes of constant UV exposure to saturated cornea
Epi-Off Continuous
Continuous beam of UV light treating cornea without surface epithelium present
Epithelium-Off Riboflavin
Riboflavin 0.1% Phosphate Sodium solution
UV Light - Continuous Beam
5 minutes of constant UV exposure to saturated cornea
Epi-On Pulsed
Pulsed beam of UV light treating cornea with surface epithelium present
Epithelium-On Riboflavin
Riboflavin 0.1% Phosphate Sodium solution with Benzalkonium Chloride Preservative
UV Pulsed Beam
5 minutes of UV exposure to saturated cornea, alternating 1 minute of treatment with 1 minute rest for a total time of 10 minutes
Epi-Off Pulsed
Pulsed beam of UV light treating cornea without surface epithelium present
Epithelium-Off Riboflavin
Riboflavin 0.1% Phosphate Sodium solution
UV Pulsed Beam
5 minutes of UV exposure to saturated cornea, alternating 1 minute of treatment with 1 minute rest for a total time of 10 minutes
Interventions
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Epithelium-On Riboflavin
Riboflavin 0.1% Phosphate Sodium solution with Benzalkonium Chloride Preservative
Epithelium-Off Riboflavin
Riboflavin 0.1% Phosphate Sodium solution
UV Light - Continuous Beam
5 minutes of constant UV exposure to saturated cornea
UV Pulsed Beam
5 minutes of UV exposure to saturated cornea, alternating 1 minute of treatment with 1 minute rest for a total time of 10 minutes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Having a clinical diagnosis of progressive keratoconus consistent with:
1. An increase of ≥ 1.00 D in the steepest keratometry value
2. An increase of ≥ 1.00 D in astigmatism manifest refraction
3. A myopic shift (decrease in the spherical equivalent) of ≥ 0.50 D on subjective manifest refraction
* Presence of central or inferior steepening on the topography map.
* Axial topography consistent with keratoconus
* Steepest keratometry (Kmax) value ≥ 47.00 D
* Signed written informed consent
* Willingness and ability to comply with schedule for follow-up visits
* Contact lens removal prior to evaluation and treatment
* History of having undergone a keratorefractive procedure and:
1. Steepening by topography
2. Thinning of cornea
3. Shift in the position of thinnest portion of cornea
4. Change in refraction with increasing myopia
5. Development of myopic astigmatism
6. Development of irregular astigmatism
7. Loss of Best Spectacle Corrected Visual Acuity
* At least two of the above criteria must be present.
* 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.
1. These patients would have the choice of ring explant before Cross-Linking.
2. Cross-Linking may still be performed if the patient wishes to retain the rings.
* Should a patient's situation due to factors such as significantly high myopia or astigmatism should warrant simultaneous placement of Intacs and cross-linking in the investigators opinion, then this option can be offered to the patient. Such interventions would be tracked as a different arm of the study.
* History of having undergone radial keratotomy (RK) and or astigmatic keratotomy (AK) surgery.
* Expressing complaints about difficulties due to vision changing during the same day.
* A difference in their Manifest Refraction (MRx) of greater than 0.75 D measured on the same day, at least 6 hours apart.
* Intacs surgery will not be considered in patients with RK/AK.
Exclusion Criteria
* Corneal pachymetry ≤ 350 microns at the thinnest point measured by Orbscan, Pentacam, or ultrasound in the eye to be treated
* A history of chemical injury or delayed epithelial healing in the eye to be treated.
* A known sensitivity to study medications
* Patients with significant nystagmus or any other condition that would prevent a steady gaze during the treatment
* Inability to cooperate with diagnostic tests.
* Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.
* Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking treatment.
* Patients who are unable to remain comfortable and stable, and tolerate a lid speculum for the appointed period of time for the procedure.
12 Years
ALL
No
Sponsors
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Crowd Health Research, LTD
OTHER
Responsible Party
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Principal Investigators
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Nancy A Tanchel, MD
Role: PRINCIPAL_INVESTIGATOR
Liberty Laser Eye Center
Locations
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LaserVue Eye
Santa Rosa, California, United States
Icon Lasik
Denver, Colorado, United States
Gulani Vision Institute
Jacksonville, Florida, United States
Eye Consultants of Atlanta
Atlanta, Georgia, United States
Midwest Center for Sight
Des Plaines, Illinois, United States
Bond Eye Associates
Pekin, Illinois, United States
Discover Vision Center
Leawood, Kansas, United States
Southern Eye Center
Hattiesburg, Mississippi, United States
Mercy Clinic Eye Specialists
Springfield, Missouri, United States
LASIK of Nevada
Las Vegas, Nevada, United States
James Lewis MD PC
Elkins Park, Pennsylvania, United States
Memorial Eye Institute
Harrisburg, Pennsylvania, United States
Carolina Eye Care
Mt. Pleasant, South Carolina, United States
Loden Vision Centers
Goodlettsville, Tennessee, United States
Parkhurst NuVision
San Antonio, Texas, United States
Liberty Laser Eye Center
Vienna, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CXL-CHR 1
Identifier Type: -
Identifier Source: org_study_id
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