I am pleased to announce that our cornea clinic has been chosen to participate in a Multi-Center, Randomized, Controlled Evaluation of the Safety and 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.
We are now ready to begin enrolling patients. We have received authorization to enroll no more than 40 patients who will be enrolled on a first come first served basis. To be included patients should meet the following criterion:
Be at least 12 years of age, male or female, of any race
Willingness and ability to follow all instructions and comply with schedule for follow-up visits
BSCVA of < 20/80
Presence of central or inferior steepening on the topographic map
Contact Lens Wearers Only: Removal of contact lenses is required for a 1 week period prior to the screening refraction and manifest refraction must be stable between two visits which occur at least 7 days apart.
Maximum corneal curvature as measured by a Kmax value ≥ 47.00 D
Axial topography consistent with keratoconus with marked areas of steepening
Ectasia after refractive surgery
Axial topography consistent with ectasia
Contraindications, sensitivity or known allergy to the test article(s) or their components;
Pregnant or nursing females or those planning a pregnancy or having a positive urine pregnancy test prior to the treatment of either eye 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 UV blocking lens
Eyes that have the maximum corneal curvature (Kmax), as identified
and measured by topography, outside of the central 5mm zone;
Previous ocular condition (other than refractive error)
A history of delayed epithelial healing in the eye(s) to be treated;
Patients with a current condition that, in the investigator’s opinion,
would interfere with or prolong epithelial healing;
A history of previous Limbal Relaxing Incision (LRI) procedure
Previous corneal surgery, scars or the insertion of Intacs
For the present, we are only enrolling patients who meet the above criterion bilaterally unless the diagnosis is ectasia. Following the per-treatment visit (Day -45 to Day -1), eyes will be randomized (Day 0) to one of the three treatment groups. All treated eyes will be assessed at 1 day, 1 week, 1, 3, 6, and 12 months after cross-linking.
Patients will be randomized among treatment groups with treatment times ranging from 2 to 8 minutes. No control patients will be randomized at this center, all enrollees will be treated.
After the 3 month examination of the study eye but no later than the 6 month examination window, subjects whose fellow eye meets all inclusion criteria and none of the exclusion criteria for performing the cross-linking treatment will be given the option of having cross-linking performed on their fellow eye using the same treatment regimen performed on the study eye. After treatment, treated fellow eyes will be followed for 12 months according to the same schedule and protocol as the study eyes.
All enrollees will be subject to the approval of the chief investigator.
The crosslinking treatment will be provided at no charge , however [our examination, evaluation and followup charges will be $1021.00 per eye. We will be happy to file for insurance payment of pre and post operative visits, however the patient will be responsible for the entire amount.
If you have a patient with special financial circumstances , feel free to discuss it with me personally and I will try to find a way to fund the treatment.
If you have questions regarding enrollment or eligibility of patients for this study I can be reached on my cell at 406-850-3102. Feel free to use this number any time you need consultation regarding corneal problems of any kind or if you need to refer a patient with a corneal problem for evaluation or care. Also feel free to tell us how our comprehensive cornea service can better serve your clinical needs.
My Thanks in Advance,
C. Byron Smith, M.D.