posted Jul 14, 2012, 12:03 PM by Jen Weigel
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updated Aug 9, 2012, 5:55 PM
]
If you want more CXL information, there are two good websites that can provide what you're looking for: Avedro's company website summarizes what they are doing to help patients with ectasia. According to Avedro, they are the world leader in corneal cross-linking science. The National Institutes of Health provides a summary of all FDA studies, including this upcoming CXL study. Visit this link to learn more about the study's details, including a list of inclusion and exclusion criteria. To highlight some important points, as taken directly from the NIH website mentioned above:
Official
study name: A Multi-Center,
Randomized, Controlled Evaluation of the Safety and Efficacy of the KXL System
with VibeX
(Riboflavin Ophthalmic Solution) for Corneal Cross-Linking in Eyes with KCN or
Corneal Ectasia
after Refractive Surgery NOTE: Drs. Holzman and Solomon
will be enrolling KCN patients only into this study.
Official study objective: To evaluate and compare the safety and
efficacy of three treatment regimens for corneal collagen cross-linking
performed with VibeX (Ribofavin
Ophthalmic Solution) and the KXL System
for reducing corneal curvature.
Inclusion and exclusion criteria, as shown on the NIH website:
Inclusion Criteria (all subjects):
- Having a diagnosis of mild, moderate or severe keratoconus
- Steepest keratometry (Kmax) value ≥ 47.00 D
Exclusion Criteria:
- Contraindications or sensitivity or known allergy to the use of the test article(s) or their components
- If female, be pregnant, nursing or
planning a pregnancy or have a positive urine pregnancy test at Visit 2
prior to randomization or during the course of the study
- Corneal pachymetry that is < 375 microns prior to epithelial debridement at the thinnest point in the eye to be treated
- Eyes which are aphakic
- Eyes which are pseudophakic and do not have a ultraviolet blocking lens implanted;
- Eyes that have the maximum corneal curvature (Kmax) outside of the 5mm zone
- Previous ocular condition (other than
refractive error) in the eye to be treated that may predispose the eye
for future complications.
- A history of delayed epithelial healing in the eye(s) to be treated
- Patients with nystagmus or any other condition that would prevent a steady gaze during the treatment or other diagnostic tests
- Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing
- Taking Vitamin C supplements within 1 week of the cross-linking treatment
- History of previous cross-linking treatment in the eye to be treated
- Have used an investigational drug or
device or be concurrently enrolled in another investigational drug or
device trial within 30 days of the study
- A history of previous Limbal Relaxing Incision procedure in the eye(s) treated
- Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme
- A history of previous corneal surgery or the insertion of Intacs in the eye to be treated. - jw
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