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The Eye Clinic Surgicenter

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Collagen Crosslinking Test Study

We have some exciting news! Our office may be partaking in a test study for Collagen Cross-Linking in Eyes with Keratoconus or Corneal Ectasia after Refractive Surgery. The details have not been finalized yet but if we are selected to participate we will update our blog with more information!

At this moment we are not yet enrolling patients for the study. Take a peek at the below general criterion to get an idea of what we may be looking for. Study specifics may vary. Check back soon for an update!


Criteria

All Patients enrolled must meet all of the following:

  • 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.
  • Keratoconus Patients
  • Maximum corneal curvature as measured by a Kmax value ≥ 47.00 D
  • Axial topography consistent with keratoconus with marked areas of steepening
  • Ectasia Patients
  • Ectasia after refractive surgery
  • Axial topography consistent with ectasia

Ineligible Patients

Ineligible Patients:

  • 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

Other Considerations

Other Considerations:
For the present, we are not enrolling patients in a study so we do not know the specifics, if any, yet.

CloseHave questions? Contact Susanne Earpenbach at 406-252-6608

My Thanks in Advance,
C. Byron Smith, M.D.