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| Sponsor: | Innovative Medical |
|---|---|
| Information provided by: | Innovative Medical |
| ClinicalTrials.gov Identifier: | NCT01024322 |
Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Keratoconus Ectasia Degeneration |
Drug: Ciprofloxicine or Vigamox or other. Drug: Nonsteroidal (Acular, Voltaren Xibrom, etc) Drug: Steroid (FML, Pred Forte, Flarex, etc.) |
Phase IV |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas |
| Estimated Enrollment: | 500 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Ciprofloxicine or Vigamox or other. |
Drug: Ciprofloxicine or Vigamox or other.
Ciprofloxicine or Vigamox or other to be used qid till epithelialized.
|
| Nonsteroidal (Acular, Voltaren Xibrom, etc) |
Drug: Nonsteroidal (Acular, Voltaren Xibrom, etc)
Nonsteroidal (Acular, Voltaren Xibrom, etc) used up to qid for up to 5-10 days post-op
|
| Steroid (FML, Pred Forte, Flarex, etc.) |
Drug: Steroid (FML, Pred Forte, Flarex, etc.)
Steroid (FML, Pred Forte, Flarex, etc.) to be used qid for 8 weeks.
|
Eligibility| Ages Eligible for Study: | 8 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Primary care clinic.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jenna Piel | 951-653-5566 | j.piel@imedsonline.com |
| Contact: Annie Christensen | 951-653-5566 | a.christensen@imedsonline.com |
| United States, Florida | |
| The Center for Excellence in Eye Care | Recruiting |
| Miami, Florida, United States | |
| United States, Maryland | |
| Washington Eye Physicians and Surgeons | Recruiting |
| Chevy Chase, Maryland, United States | |
| Principal Investigator: | William Trattler, MD | The Center for Excellence in Eye Care |
| Principal Investigator: | Roy Rubinfeld, MD | Washington Eye Physicians and Surgeons |
More Information
| Responsible Party: | Melissa Earl, CRO |
| ClinicalTrials.gov Identifier: | NCT01024322 History of Changes |
| Other Study ID Numbers: | CXL |
| Study First Received: | October 28, 2009 |
| Last Updated: | January 13, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
Diagnosis of keratoconus, post-LASIK ectasia, FFKC, or pellucid marginal degeneration |
|
Dilatation, Pathologic Keratoconus Pathological Conditions, Anatomical Corneal Diseases Eye Diseases Diclofenac Bromfenac Ketorolac Tromethamine Methylprednisolone acetate Prednisolone acetate Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone Prednisolone phosphate Moxifloxacin |
Norgestimate, ethinyl estradiol drug combination Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
