Corneal Cross-Linking Comparing Variables



Status:Not yet recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:12 - Any
Updated:4/2/2016
Start Date:May 2014
Contact:Travis A Johnson, Bachelor's
Email:tjohnson@libertylasereye.com
Phone:571-234-5678

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Study of Safety and Efficacy of Photochemically Induced Collagen Cross-Linking at an Irradiance of 18 mW/cm2 as Constant or Pulsed Treatment in Eyes With Unstable Corneas Due to Keratoconus, Ectasia, or Post-Incisional Refractive Surgery

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.


Inclusion Criteria Keratoconus:

- 12 years of age or older

- 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

Inclusion Criteria Post-Surgical Ectasia:

- 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.

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.

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.

Inclusion Criteria RK/AK Fluctuation:

- 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:

- Eyes classified as either normal, atypical normal,

- 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.
We found this trial at
16
sites
Atlanta, Georgia 30339
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Denver, Colorado 80210
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Denver, CO
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Des Plaines, Illinois 60016
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Des Plaines, IL
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Elkins Park, Pennsylvania 19027
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Elkins Park, PA
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Goodlettsville, Tennessee 37072
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Harrisburg, Pennsylvania 17112
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Harrisburg, PA
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Hattiesburg, Mississippi 39402
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Jacksonville, Florida 32216
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Jacksonville, FL
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Las Vegas, Nevada 89123
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Las Vegas, NV
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Leawood, Kansas 66211
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Mt. Pleasant, South Carolina 29464
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Pekin, Illinois 61554
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Pekin, IL
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San Antonio, Texas 78229
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San Antonio, TX
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Santa Rosa, California 95403
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Santa Rosa, CA
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Springfield, Missouri 65807
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Springfield, MO
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Vienna, Virginia 22182
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Vienna, VA
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