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ICL - PIOL and Specular

Endothelial Cell Counts are Required for ICL Implantation

Konan’s Gold Standard specular has been used for virtually all ICL clinical trials.

Your patients deserve the assurance of the collecting the same high quality data to assess and document that the cornea is physiologically adequate to support these surgical interventions.

Every phakic lens candidate is to have a minimum of 3.2 mm anterior chamber depth and a baseline endothelial cell count of more than 2,000. “Phakic IOLs Find a Solid Niche” (Ophthalmology Management, September 2009) Vance Thompson, MD

It is important to select patients whose endothelial cell density and morphology are normal.

Avoiding Complications with Phakic IOLs” (Cataract and Refractive Surgery Today, October 2009)

Theodore Perl, MD

ICL (implantable contact lens) or PIOL (phakic intra ocular lens)

An endothelial cell count to verify that a patient’s cornea has an adequate endothelial cell density is an FDA labeling requirement for patient screening and selection prior to implantation of phakic intraocular lenses (Intraocular Contact Lenses, or “ICLs”). Without an adequate endothelial cell count, the current ICLs are contraindicated for implantation and clearly highlights the importance of this screening procedure. Endothelial cell density must be accurately checked preoperatively to ensure that a patient is a suitable candidate, and then should be monitored periodically postoperatively to verify the endothelium’s continued health. Although an endothelial cell count can be crudely estimated using a card developed in the 1980′s, this technique has significant limitations that are now well answered with Konan’s specular microscopy technologies:

  • High precision and repeatability
  • Excellent visualization of even stage +1 / +2 guttata that could significantly skew results
  • Analysis of both cell counts and cell morphology changes (morphology is not assessed with a “card”)
  • Changes in morphology can be a very sensitive indicator of corneal stress
  • Unique ability to identify endothelial data location and assess trends over time
  • Acquiring endothelial cell count or morphology changes over time from dissimilar locations can present erroneous assumptions on trends analysis
  • Technician administered diagnostic test with full photographic documentation and statistics in only seconds.
  • Does not require additional physician chair time and eliminates the inherent problems of “card” estimates.
  • Important complementary uses for pre-operative assessments of corneal and other anterior segment procedures

ICL Products

Premium refractive products require premium attention to eligibility.  Konan CellChek provides easy to use yet robust analytics to assure proper patient selection.  There is a reason major manufacturers of ICL’s use Konan specular microscopes for collection of FDA safety data. Your patients deserve no less.

FDA Professional labeling including ECD minimum requirements:

http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030016c.pdf

Visian ICL™

Staar Surgical™

FDA Professional labeling including ECD minimum:

http://www.accessdata.fda.gov/cdrh_docs/pdf3/p030028b.pdf

Verisyse™

Abbott Medical Optics™

AcrySof® Cachet®

Phakic IOL, Alcon®

Visian ICL, Staar Surgical, Verisyse, Abbot Medical Optics,  AcrySof Cachet, and ALCON are trademarks of their respective owners.