Canadian Ophthalmological Society practice guidelines for refractive surgery Canadian Ophthalmological Society Working Group on Refractive Surgery Practice Guidelines* DEFINITION
Refractive surgery encompasses those surgical procedures that correct ametropia. These procedures may involve the use of a medical device (laser or surgical implant) or surgical instrumentation or both. Extraocular procedures include those surgical procedures performed directly on the cornea or sclera. Intraocular procedures include those surgical procedures on the crystalline lens or within the anterior or posterior chamber.
as suitable candidates. Monocular patients should be excluded. Suitable candidates for refractive surgery must have a reasonable expectation of success. This will obviously depend on the patient's age, refractive error and specific reasons for considering refractive surgery. Presbyopic patients undergoing refractive surgery to rid themselves of their distance prescription must be made aware that they will require reading eyeglasses unless they elect to have monovision or elect to undergo surgical procedures to reverse presbyopia.
INDICATIONS PREOPERATIVE OPHTHALMIC TESTING
People wishing to reduce or eliminate their need for eyeglasses and contact lenses may consider refractive surgery. SUITABILITY
Patients should be 18 years of age or older, have a stable refractive error and have healthy eyes. Ocular conditions, medical conditions or systemic medications that might alter the stability of the refraction, interfere with wound healing or potentially affect the outcome of the procedure should be noted and may serve to exclude the patient as a suitable candidate. Amblyopic patients with a best corrected acuity in the amblyopic eye of less than 20/40 should be excluded
*Members: Calvin Breslin. MD (Chair), University of Toronto; Gordon Balazsi, MD, McGill University, Montreal; William Dixon, MD, University of Toronto; Paul Dubord, MD, University of British Columbia, Vancouver; W. Bruce Jackson, MD, University of Ottawa; and Ronald Jans, MD, University of Calgary These guidelines were approved by the Canadian Ophthalmological Society Board of Directors at a meeting held in Whistler, BC, June 17, 2000.
Can J Ophthalmol 2000;35:307-8
Refractive surgery guidelines
The results of a medical ocular examination, including an appropriate ocular, medical and drug history, cycloplegic refraction, pupillometry in bright and dim light, pachymetry and computerized corneal topography, should be documented in the patient's chart. Ancillary tests may include specular microscopy of the corneal endothelium and A-scan biometry. Measuring the diameter of the pupils (pupillometry) in bright and dim light is best accomplished with the use of a Colvard pupillometer or similar instrument rather than the pupil gauge on a near-vision card. The pupil gauge on the near-vision card has a tendency to underestimate the size of the pupil in dim light. Pachymetry is best accomplished using an ultrasound pachymeter rather than an optical pachymeter attached to the slit lamp. Contact lens wearers who are considering refractive surgery should stop wearing their lenses and the refraction allowed to stabilize. Computerized topography should show a regular corneal surface. A stable refraction is defined as similar refractions separated by an appropriate interval. INFORMED CONSENT
All patients are required to sign a detailed informed
Refractive surgery guidelines
consent form. The consent form should be written using simple language. The consent form will state the name and telephone number of the operating surgeon or investigator, the nature of the procedure to be performed as explained by the operating surgeon or investigator, the current status of the procedure, and any reported complications of or adverse reactions to the procedure. Diagrams should be used where appropriate to explain difficult concepts and procedures. POSTOPERATIVE CARE
The operating surgeon should perform the first postoperative visit on the day after the procedure. Additional visits will be scheduled as determined by the patient's response to treatment or the development of an adverse reaction or complication. The patient will be discharged from care when healing is complete, as manifested by a stable refraction. The operating surgeon may transfer the care of the patient to another health care provider at her or his discretion. The patient must voluntarily consent to this arrangement, and this consent should be documented in the patient's medical record. The patient is to be informed, before the procedure, as to who will be performing his or her postoperative care. It is the operating surgeon's responsibility to ensure that the health care provider is appropriately trained and qualified to provide the care required. On the first postoperative visit the operating surgeon should be available to the health care provider to manage any adverse reaction or complication that might arise. In the early postoperative period the patient should be provided with an after-hours emergency telephone number giving her or him access to the operating surgeon or designated health care provider.
CAN J OPHTHALMOL-VOL. 35, NO. 6, 2000
Surgeons performing refractive surgery should be ophthalmologists licensed in the province in which they practise. They should be familiar with all the instrumentation and equipment they will be using and should be adequately trained in the procedures they will perform. Adequate training includes: (1) didactic sessions on the theory and performance of the procedure, the postoperative care, and the recognition and management of complications; (2) wet labs or practical sessions under supervision to gain familiarity with the use of the equipment and instruments; (3) observation of "live" surgery performed by an approved trainer or investigator in the procedure; and (4) performance of the procedure in the presence of a preceptor. Technical staff assisting the refractive surgeon should be appropriately trained and familiar with all the instrumentation and equipment they will be using. MAINTENANCE OF EQUIPMENT
All instruments and equipment must be maintained and serviced according to the manufacturer's recommendations. REPORTING OF ADVERSE REACTIONS
Serious adverse reactions should be reported to the Health Protection Branch of Health Canada, the institutional review board overseeing the procedure, if investigational, and the manufacturer of the particular device, instrument or piece of equipment.