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Terminated to initiate FDA IND-cleared study protocol
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The purpose of this study is to evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) as a method to increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within or between collagen fibers using UVA light and the photo- mediator riboflavin. The purpose of this study is to generate data for presentation at medical meetings and for peer-review publication. The data generated by this study will not be submitted to the FDA to support commercialization of these riboflavin drops.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ciprofloxicin or Vigamox or other. |
| ||
| Nonsteroidal (Acular, Voltaren Xibrom, etc) |
| ||
| Steroid (FML, Pred Forte, Flarex, etc.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciprofloxicin or Vigamox or other. | Drug | Ciprofloxicin or Vigamox or other to be used qid till epithelialized. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| increase the biomechanical and biochemical stability of the cornea between collagen fibers using UVA light and the photo- mediator riboflavin | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Primary care clinic.
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| Name | Affiliation | Role |
|---|---|---|
| William Trattler, MD | The Center for Excellence in Eye Care | Principal Investigator |
| Jodi Luchs, MD | South Shore Eye Care LLP | Principal Investigator |
| Shamik Bafna, MD | Cleveland Eye Clinic | Principal Investigator |
| Parag Majmudar, MD | Chicago Cornea Consultants, LTD | Principal Investigator |
| Jay Schwartz, MD | Schwartz Laser Eye Center | Principal Investigator |
| Jonathan Davidorf, MD | Davidorf Eye Group | Principal Investigator |
| Daniel Goodman, MD | Goodman Eye Center | Principal Investigator |
| Jonathan Talamo, MD | Talamo Laser Eye Center | Principal Investigator |
| Sandy Feldman, MD | Clear View Eye & Laser Medical Center | Principal Investigator |
| Gregg Berdy, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schwartz Laser Eye Center | Scottsdale | Arizona | 85260 | United States | ||
| Harvard Eye Associates |
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| Nonsteroidal (Acular, Acuvail, Voltaren Xibrom, etc) | Drug | Nonsteroidal (Acular, Voltaren Xibrom, etc) qid up to 5-10 days post-op |
|
| Steroid (FML, Pred Forte, Flarex, etc.) | Drug | Steroid (FML, Pred Forte, Flarex, etc.) to be used qid to qd for 1-8 weeks. |
|
| Ophthalomology Associates |
| Principal Investigator |
| Lance Forstot | Corneal Consultants of Colorado, P.C | Principal Investigator |
| Mark Kontos, MD | Empire Eye Physicians | Principal Investigator |
| Audrey Rostov, MD | Northwest Eye Surgeons | Principal Investigator |
| John Hovanesian, MD | Harvard Eye Associates | Principal Investigator |
| Laguna Hills |
| California |
| United States |
| Clear View Eye & Laser Medical Center | San Diego | California | United States |
| San Francisco | California | United States |
| Davidorf Eye Group | West Hills | California | United States |
| Corneal Consultants of Colorado, P.C | Littleton | Colorado | United States |
| The Center for Excellence in Eye Care | Miami | Florida | 33176 | United States |
| Chicago Cornea Consultants, LTD | Hoffman Estates | Illinois | 60169 | United States |
| TLC Laser Eye Center | Rockville | Maryland | 20852 | United States |
| Talamo Laser Eye Center | Waltham | Massachusetts | United States |
| Ophthalomology Associates | St Louis | Missouri | United States |
| South Shore Eye Care LLP | Wantagh | New York | 11793 | United States |
| Cleveland Eye Clinic | Brecksville | Ohio | 44141 | United States |
| TLC Laser Eye Center | Fairfax | Virginia | 22031 | United States |
| Northwest Eye Surgeons | Seattle | Washington | United States |
| Empire Eye Physicians | Spokane Valley | Washington | United States |
| ID | Term |
|---|---|
| D007640 | Keratoconus |
| D004108 | Dilatation, Pathologic |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| D020911 | Ketorolac Tromethamine |
| D020910 | Ketorolac |
| D013256 | Steroids |
| D005469 | Fluorometholone |
| C009935 | prednisolone acetate |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013259 | Steroids, Fluorinated |
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