February 15, 2004

The Promise of Refractive Surgery: A Promise Not Kept

An Insiders Journal on the Evolution and Misinformation of Refractive Surgery

Dedicated to:

And the thousands of others whose quality of life has suffered greatly as a result of believing the professionally communicated promise of refractive surgery

Table of Contents

Section

 Page

Introduction

2

Refractive Surgery and Misinformation

 3

Fundamentals of LASIK

5

  • LASIK’s surgical landscape: the Cornea

  • Asphericity and imaging of light rays on the retina

  • The loss of contrast sensitivity and quality of vision

  • Dry eye

  • DLK (diffuse lamellar keratitis)

  • Accuracy of the microkeratome

  • Enhancements and the use of misleading terms

Informed Consent

12

  • The absence of incidence data

  • A physician’s internally developed data

  • Physician use of manufacturer sales aids

  • Physician’s and conflicts of interest

  • Referrals to LASIK surgeons

  • Looking through a patient’s eyes

  • Websites

  • Recent FTC actions

FDA Approvals

16

  • Adverse events, complications, and visual symptoms

  • LASIK – an unapproved, off-label use of medical technology

  • LASIK – the initial & unusual FDA approval
          Day One
          Day Two

  • "Company Sponsored" LASIK PMAs
          Approval for the Bausch & Lomb Technolas™ 217A Excimer Laser for LASIK
          University of Rochester Survey of FDA Approved Lasers

Reported Patient Problems and Their Incidence

20

Discerning the Truth About the "Next Big Thing"

23

  • Wavefront guided LASIK

  • IntraLASIK™ (Intralase™ LASIK)

  • LASEK (an emerging off-label procedure)

  • Radio-frequency based procedures for hyperopia

  • Lens Based Refractive Surgery

  • The ICL™ (implantable contact lens)

  • The Artisan™ Lens

Summary

 31

Appendix A

 32

The complete article in Adobe PDF format

This article was published anonymously by refractivesurgeryinsider@yahoo.com

 

Posted by Admin at February 15, 2004 08:31 PM
Comments
thanks Posted by: Jim at October 21, 2004 10:06 AM
Comments
This is a must read for anyone considering Refractive Surgery. The title should be, in bold type, BUYER BEWARE! Posted by: gospa at October 3, 2004 01:28 PM