**We are not currently enrolling patients in this trial**
ClearKone is a prescription hybrid contact lens introduced in May 2009 by SynergEyes, Inc. A hybrid contact lens is a lens composed of a rigid gas permeable lens in the center that is surrounded by a soft contact lens.
SynergEyes, Inc. (Carlsbad, CA), the manufacturer of the only FDA-cleared hybrid contact lenses specifically designed for keratoconus, has previously released four hybrid lens designs; “A” for standard corneas, the “KC” lens for keratoconus, “PS” for post-surgical eyes, and a multifocal lens, “M”, for presbyopic patients. Similar to the KC lens, ClearKone was released specifically for patients with keratoconus. Moreover, ClearKone is designed to fit a broader range of patients diagnosed with moderate to advanced keratoconus. Corneal collagen crosslinking (CXL) is a procedure that involves administering riboflavin and ultraviolet light (UVA) to strengthen the anterior layers of the cornea. CXL has been proposed as an effective method of halting or reducing progression of keratoconus and corneal ectasia. Intacs are intracorneal ring segments implanted into the cornea and make the corneal optical surface smoother. These two surgical procedures may aid non-surgical treatment options such as utilizing a contact lens to further improve vision.
Studies have reported increased lens tolerability in irregular cornea patients fitted with hybrid contact lenses with over 85% success rate. In those cases, best corrected visual acuities typically improve while wearing hybrid lenses when compared to rigid gas permeable (RGP) lenses. As a result, patients often report subjective improvement in their quality of life.
ClearKone hybrid contact lens may further improve vision for patients with keratoconus or corneal ectasia who have subsequently had CXL or CXL combined with Intacs surgical procedure(s). Currently, there exists limited data regarding ClearKone’s performance in this population.
Here at the CLEI Center for Keratoconus, we have treated approximately 90 patients with CXL in a clinical trial over the past two years and have been working with Intacs for keratoconus for several years. Our data analysis and research with Intacs over the years have let us develop enhancements to the procedure such as creating Intacs tunnel geometries and the use of different Intacs sizes. We have been fitting SynergEyes hybrid lenses for numerous years and the ClearKone contact lenses since its release.
NEW STUDY OF CLEARKONE LENS ON PATIENTS WHO HAVE RECEIVED CORNEAL COLLAGEN CROSSLINKING OR COMBINATION CORNEAL COLLAGEN CROSSLINKING AND INTACS:
We are pleased to announce that we are currently enrolling patients in a
study evaluating the performance of ClearKone contact lens on patients with keratoconus or corneal ectasia who have received either 1) corneal collagen crosslinking (CXL), or 2) combined CXL and Intacs surgical procedure(s). The study is being conducted to determine the effectiveness of SynergEyes ClearKone hybrid contact lens in improving corrected visual acuity. As well, this study will assess any improvements in corneal optics as a result of wearing these lenses.
For further information about this study please call (201) 883-0505 or email firstname.lastname@example.org.