Safety & Efficacy of Corneal Collagen Cross-Linking in Eyes With Keratoconus or Corneal Ectasia After Refractive Surgery



Status:Terminated
Conditions:Ocular, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery, Ophthalmology
Healthy:No
Age Range:12 - Any
Updated:7/5/2018
Start Date:July 2012
End Date:August 2016

Use our guide to learn which trials are right for you!

Multi-Center, Randomized, Controlled Evaluation of the Safety & Efficacy of the KXL System With VibeX (Riboflavin Ophthalmic Solution) for Corneal Collagen Cross-Linking in Eyes With Keratoconus or Corneal Ectasia After Refractive Surgery

The objectives of this study are to evaluate and compare the safety and efficacy of three
treatment regimens for corneal collagen cross-linking performed with VibeX (riboflavin
ophthalmic solution) and the KXL System in impeding the progression of, and/or reducing
maximum corneal curvature.


Inclusion Criteria (all subjects):

1. Be at least 12 years of age, male or female, of any race;

2. Provide written informed consent and sign a HIPAA form. Patients who are under the age
of 18 will need to sign an assent form as well as having a parent or legal guardian
sign an informed consent;

3. Willingness and ability to follow all instructions and comply with schedule for
follow-up visits;

4. For females capable of becoming pregnant, agree to have urine pregnancy testing
performed prior to randomization of the study eye and on the day of the fellow eye
treatment (which occurs between the 3 to 6 month study eye visits); must not be
lactating, and must agree to use a medically acceptable form of birth control for at
least one week prior to the randomization visit and continue to use the method until
one month after the last dose of test article. Acceptable forms for birth control are
spermicide with barrier, oral contraceptive, injectable or implantable method of
contraception, transdermal contraceptive, intrauterine device, or surgical
sterilization of partner. For non-sexually active females, abstinence will be
considered an acceptable form of birth control. Women considered capable of becoming
pregnant include all females who have experienced menarche and have not experienced
menopause (as defined by amenorrhea for greater than 12 consecutive months) or have
not undergone successful surgical sterilization (e.g. hysterectomy, bilateral tubal
ligation, or bilateral oophorectomy);

5. BSCVA of ≥1 letter and ≤80 letters on ETDRS chart;

6. Presence of central or inferior steepening on the topographic map;

7. Contact Lens Wearers Only: Removal of contact lenses is required for a 1 week period
prior to the screening visit(s);

8. Contact Lens Wearers Only: manifest refraction must be stable between two visits which
occur at least 7 days apart. A stable refraction is one in which the manifest
refraction spherical equivalent and the average K (Km) on the topographer taken at the
first visit do not differ by more than 0.75 D from the respective measurements taken
at the second exam;

Inclusion Criteria (keratoconus subjects only):

9. Have a maximum corneal curvature as measured by Kmax of ≥ 47.00 D;

10. Having topographic evidence of keratoconus with a diagnosis of mild, moderate or
severe keratoconus defined as the following:

- Mild Keratoconus

1. Axial topography consistent with keratoconus

2. Flat keratometry reading ≤ 51.00 D on topography map

- Moderate Keratoconus

1. Axial topography consistent with keratoconus

2. Flat keratometry reading ≥ 51.01 D and ≤ 56.00 D or astigmatism ≥ 8.00D on
topography map

- Severe Keratoconus:

1. Axial topography consistent with keratoconus with marked areas of steepening

2. Flat keratometry reading ≥ 56.01 D on topography map

Inclusion Criteria (corneal ectasia subjects only):

11. Having a diagnosis of corneal ectasia after refractive surgery;

12. Having axial topography consistent with ectasia;

Exclusion Criteria (all subjects):

1. Contraindications, sensitivity or known allergy to the test article(s) or their
components;

2. If female, be pregnant, nursing or planning a pregnancy or have a positive urine
pregnancy test prior to the randomization or treatment of either eye or during the
course of the study;

3. Corneal pachymetry that is < 375 microns prior to epithelial debridement at the
thinnest point in the eye to be treated;

4. Eyes which are aphakic;

5. Eyes which are pseudophakic and do not have a UV blocking lens implanted;

6. Previous ocular condition (other than refractive error) in the eye to be treated that
may predispose the eye for future complications. For example:

1. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis,
recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.)

2. Clinically significant corneal scarring in the cross-linking treatment zone that
is not related to keratoconus or corneal ectasia, in the investigator's opinion,
will interfere with the cross-linking procedure;

7. A history of delayed epithelial healing in the eye(s) to be treated;

8. Patients with nystagmus or any other condition that would prevent a steady gaze during
the treatment or other diagnostic tests;

9. Patients with a current condition that, in the investigator's opinion, would interfere
with or prolong epithelial healing;

10. Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking
treatment.

11. A history of previous corneal crosslinking treatment in the eye to be treated;

12. Have used an investigational drug or device within 30 days of the study or be
concurrently enrolled in another investigational drug or device trial within 30 days
of the study;

13. A history of previous corneal surgery (other than LASIK or PRK for subjects with
corneal ectasia) or the insertion of Intacs in the eye(s) to be treated;

14. A history of previous Limbal Relaxing Incision (LRI) procedure in the eye(s) to be
treated;

15. In addition, the Investigator may exclude or discontinue any subject for any sound
medical reason;

Exclusion Criteria (Keratoconus subjects only):

16. Eyes classified as either normal, atypical normal, or keratoconus suspect on the
severity grading scheme.
We found this trial at
83
sites
?
mi
from
Madison, WI
Click here to add this to my saved trials
Albuquerque, New Mexico 87109
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Annandale, Virginia 22003
?
mi
from
Annandale, VA
Click here to add this to my saved trials
Austin, Texas 78746
?
mi
from
Austin, TX
Click here to add this to my saved trials
100 Presidential Boulevard
Bala-Cynwyd, Pennsylvania 19004
?
mi
from
Bala-Cynwyd, PA
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Belleville, Illinois 62226
?
mi
from
Belleville, IL
Click here to add this to my saved trials
Billings, Montana 59102
?
mi
from
Billings, MT
Click here to add this to my saved trials
Birmingham, Alabama 35233
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Bloomington, Minnesota 55420
?
mi
from
Bloomington, MN
Click here to add this to my saved trials
Bowie, Maryland 20716
?
mi
from
Bowie, MD
Click here to add this to my saved trials
Brookline, Massachusetts 02446
?
mi
from
Brookline, MA
Click here to add this to my saved trials
?
mi
from
Chesterfield, MO
Click here to add this to my saved trials
Chevy Chase, Maryland 20815
?
mi
from
Chevy Chase, MD
Click here to add this to my saved trials
Coral Gables, Florida 33134
?
mi
from
Coral Gables, FL
Click here to add this to my saved trials
?
mi
from
Coralville, IA
Click here to add this to my saved trials
De Witt, New York 13214
?
mi
from
De Witt, NY
Click here to add this to my saved trials
Delray Beach, Florida 33484
?
mi
from
Delray Beach, FL
Click here to add this to my saved trials
Denver, Colorado 80210
?
mi
from
Denver, CO
Click here to add this to my saved trials
Detroit, Michigan 48202
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Draper, Utah 84020
?
mi
from
Draper, UT
Click here to add this to my saved trials
El Paso, Texas 79902
?
mi
from
El Paso, TX
Click here to add this to my saved trials
Fargo, North Dakota 58103
?
mi
from
Fargo, ND
Click here to add this to my saved trials
Fayetteville, North Carolina 28303
?
mi
from
Fayetteville, NC
Click here to add this to my saved trials
Federal Way, Washington 98003
?
mi
from
Federal Way, WA
Click here to add this to my saved trials
Goodlettsville, Tennessee 37072
?
mi
from
Goodlettsville, TN
Click here to add this to my saved trials
Grand Rapids, Michigan 49546
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
Grapevine, Texas 76051
?
mi
from
Grapevine, TX
Click here to add this to my saved trials
Great Neck, New York 11021
?
mi
from
Great Neck, NY
Click here to add this to my saved trials
Hallandale Beach, Florida 33009
?
mi
from
Hallandale Beach, FL
Click here to add this to my saved trials
Harrisburg, Pennsylvania 17110
?
mi
from
Harrisburg, PA
Click here to add this to my saved trials
Houston, Texas 77027
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77027
?
mi
from
Houston, TX
Click here to add this to my saved trials
La Crosse, Wisconsin 54601
?
mi
from
La Crosse, WI
Click here to add this to my saved trials
Largo, Florida 33770
?
mi
from
Largo, FL
Click here to add this to my saved trials
Las Vegas, Nevada 89119
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Leawood, Kansas 66211
?
mi
from
Leawood, KS
Click here to add this to my saved trials
Lincoln, Nebraska 38506
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
Los Angeles, California 90067
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Louisville, Kentucky 40207
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Madison, Mississippi 39110
?
mi
from
Madison, MS
Click here to add this to my saved trials
Manchester, Connecticut 06040
?
mi
from
Manchester, CT
Click here to add this to my saved trials
Milford, Connecticut 06460
?
mi
from
Milford, CT
Click here to add this to my saved trials
Nashville, Tennessee 37203
?
mi
from
Nashville, TN
Click here to add this to my saved trials
1514 Jefferson Hwy.
New Orleans, Louisiana 70121
504-842-3000
Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
Norfolk, Virginia 23502
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73104
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Omaha, Nebraska 68144
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Orlando, Florida 32803
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Palo Alto, California 94304
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19107
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 85016
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Pomona, New York 10970
?
mi
from
Pomona, NY
Click here to add this to my saved trials
Portland, Maine 04102
?
mi
from
Portland, ME
Click here to add this to my saved trials
Portland, Oregon 97239
?
mi
from
Portland, OR
Click here to add this to my saved trials
Portland, Oregon 97210
?
mi
from
Portland, OR
Click here to add this to my saved trials
Princeton, New Jersey 08540
?
mi
from
Princeton, NJ
Click here to add this to my saved trials
Rapid City, South Dakota 57701
?
mi
from
Rapid City, SD
Click here to add this to my saved trials
Rapid City, South Dakota 57701
?
mi
from
Rapid City, SD
Click here to add this to my saved trials
Richmond, Virginia 23238
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Richmond, Virginia 23226
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Sacramento, California 95816
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Sacramento, California 95815
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Sacramento, California 95821
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
12990 Manchester Road
Saint Louis, Missouri 63131
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Salt Lake City, Utah 84107
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Antonio, Texas 78229
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Juan, 00918
?
mi
from
San Juan,
Click here to add this to my saved trials
San Leandro, California 94578
?
mi
from
San Leandro, CA
Click here to add this to my saved trials
Scranton, Pennsylvania 18503
?
mi
from
Scranton, PA
Click here to add this to my saved trials
Sioux Falls, South Dakota 57105
?
mi
from
Sioux Falls, SD
Click here to add this to my saved trials
Southfield, Michigan 48034
?
mi
from
Southfield, MI
Click here to add this to my saved trials
Stockton, California 95207
?
mi
from
Stockton, CA
Click here to add this to my saved trials
Tampa, Florida 33607
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Virginia Beach, Virginia 23454
?
mi
from
Virginia Beach, VA
Click here to add this to my saved trials
?
mi
from
Walnut Creek, CA
Click here to add this to my saved trials
Waltham, Massachusetts 02451
?
mi
from
Waltham, MA
Click here to add this to my saved trials
Westerville, Ohio 43082
?
mi
from
Westerville, OH
Click here to add this to my saved trials
Wichita, Kansas 67208
?
mi
from
Wichita, KS
Click here to add this to my saved trials
Wilkes-Barre, Pennsylvania 18702
?
mi
from
Wilkes-Barre, PA
Click here to add this to my saved trials