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Summary Recommendations for LASIK

Introduction

Issued March 28, 2002; revised June 2006; revised January 2008

These are summary recommendations, based on expert opinion and consensus, for practices that promote the patient's best interests and safety in performing (laser assisted in-situ keratomileusis) LASIK surgery.

Summary Recommendation

Training
Ophthalmologists performing LASIK surgery should have:

  • Appropriate training and certification on the laser, and laboratory experience with the microkeratome.
  • Proctoring for the first several LASIK cases.

Marketing
Promotional materials are monitored and regulated by the Federal Trade Commission and should:

  • Provide accurate information about the safety, efficacy and benefits of LASIK, based on reliable scientific evidence or consensus expert opinion (not anecdotal evidence or testimonials), including any material information about risks and limitations.

Patient Selection
In general, suitable candidates for LASIK should meet these criteria:

  • Be within FDA-approved guidelines for degree of myopia, hyperopia and astigmatism.
  • Have refractive stability over a twelve month period, at least.
  • Be at least 18 years old.
  • Have realistic expectations about the outcome of surgery.
  • In patients wearing contact lenses, lenses should be discontinued and the examination should demonstrate a stable refraction and topography. In rigid contact lens wearers, stability may be documented on successive readings (at least one week apart).

Patient Examination
In determining suitability, a baseline eye evaluation should include:

  • Manifest, and where appropriate, cycloplegic refraction
  • Measurement of intraocular pressure
  • Slit-lamp biomicroscopy
  • Tear film evaluation
  • Computerized corneal topography
  • Central corneal thickness measurement
  • Dilated fundoscopic examination
  • Evaluation of ocular motility and alignment

Patient Education
The operating ophthalmologist has the following responsibilities:

  • Inform patients about alternatives for vision correction, including glasses, contact lenses and other types of refractive surgery.
  • Obtain informed consent, explaining the risks, possible complications and side effects, including: over or under-correction, corneal scarring and inability to wear contact lenses, corneal infection, loss of best-corrected visual acuity, loss of contrast sensitivity, probems with night driving, flap problems, discomfort, blurry vision, dryness, glare, haloes, light sensitivity.
  • Discuss presbyopia.
  • Discuss monovision in presbyopic and pre-presbyopic patients.
  • Determine if expectations of patients are realistic.
  • Discuss postoperative care plans.

Performance of LASIK
The operating ophthalmologist has the following responsibilties:

  • Confirm the identity of the patient, the operative eye, and that the parameters are correctly entered into the laser's computer.

Post-operative Management
The operating ophthalmologist or a designated ophthalmologist should:

  • Perform the first post-operative visit within 48 hours following surgery.
  • Provide follow-up care throughout the patient's at risk period or arrange for this to be done by another appropriately trained ophthalmologist or optometrist.

Comanagement
The ophthalmic surgeon has the primary responsibility for the preoperative assessment and postoperative care of his/her patients, regardless of the type of surgery performed. The decision to co-manage should be the result of a determination of what is best for the patient and not economic considerations. If the co-management of patients is done on a routine basis for predominantly financial reasons, it represents unethical behavior and may be illegal. Above all, patients' interests must never be compromised as a result of co-management.

In the event that the ophthalmologist needs to co-manage with an optometrist(s), the ophthalmologist should:

  • Verify and document that the optometrist(s) has the appropriate education, training and skills to follow patients post-operatively.
  • Develop standardized guidelines and protocols regarding postoperative care of patients, particularly concerning communications.
  • Prior to surgery, inform the patient if there are any prearranged postoperative management plans, and the patient must voluntarily consent to this in writing.
  • Inform the patient of the financial implications resulting from the co-management arrangement, particularly with regard to the patient's payment obligations and the postoperative provider's reimbursement.
  • Follow the patient until postoperatively stable, and there is no fixed time when the patient is sent back to the referring provider.
  • Reassure the patient that he/she has access to the surgeon, if necessary, during the postoperative period at no additional cost.
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