Review of corneal endothelial specular microscopy for FDA clinical trials of refractive procedures, surgical devices, and new intraocular drugs and solutions

Cornea. 2008 Jan;27(1):1-16. doi: 10.1097/ICO.0b013e31815892da.


Specular microscopy can provide a noninvasive morphologic analysis of the corneal endothelial cell layer from subjects enrolled in clinical trials. The analysis provides a measure of the endothelial cell physiologic reserve from aging, ocular surgical procedures, pharmaceutical exposure, and general health of the corneal endothelium. The purpose of this review is to discuss normal and stressed endothelial cell morphology, the techniques for determining the morphology parameters, and clinical trial applications.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Cell Count
  • Clinical Trials as Topic
  • Drug Evaluation
  • Drugs, Investigational*
  • Endothelium, Corneal / cytology*
  • Endothelium, Corneal / pathology
  • Endothelium, Corneal / physiology
  • Guidelines as Topic
  • Humans
  • Microscopy / methods*
  • Ophthalmic Solutions*
  • Ophthalmologic Surgical Procedures / instrumentation*
  • Refractive Surgical Procedures*
  • United States
  • United States Food and Drug Administration


  • Drugs, Investigational
  • Ophthalmic Solutions