Informed Consent for LASIK / LASEK Refractive Surgery

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Informed Consent for LASIK / LASEK Refractive Surgery

Patient and Clinic Information

Nature and Purpose of the Procedure

Laser-Assisted In Situ Keratomileusis (LASIK) and Laser-Assisted Sub-Epithelial Keratectomy (LASEK) are elective surgical procedures designed to reduce or eliminate the patient's reliance on spectacles or contact lenses by reshaping the cornea, the clear front window of the eye. In LASIK, a thin surface flap of corneal tissue is created using either a mechanical instrument called a microkeratome or a highly precise femtosecond laser. This flap is gently folded back, exposing the underlying stromal tissue. A computer-controlled excimer laser is then used to vaporize microscopic layers of corneal tissue (ablation) to correct refractive errors (myopia, hyperopia, or astigmatism) by changing the curvature of the cornea. Once the reshaping is complete, the corneal flap is repositioned to its original location, where it adheres naturally without sutures. In LASEK, instead of a thick flap, only the outermost cellular layer of the cornea (the epithelium) is softened with an alcohol solution, folded back, and then repositioned or removed after the excimer laser ablation. A protective bandage contact lens is typically placed over the cornea after LASEK to assist in healing.

Material Risks and Potential Complications

Dry eye syndrome: a very common post-operative side effect, caused by temporary disruption of corneal nerves that stimulate tear production. Most patients experience symptoms of dry, scratchy, or burning eyes for several weeks to months, requiring frequent use of lubricating drops. In some cases, severe or chronic dry eye may persist permanently.
Visual quality disturbances: patients may experience temporary or permanent halos, glare, starbursts, or ghost images, particularly in low-light conditions or when driving at night. These disturbances are often caused by light scattering at the edge of the laser-treated zone.
Under-correction or over-correction: the healing response of corneal tissue is individual and cannot be predicted with complete certainty. A residual refractive error may remain after healing, which may require the continued use of glasses or contact lenses, or a secondary enhancement laser procedure.
Flap-related complications (LASIK): issues during or after flap creation include incomplete flaps, free caps, or buttonholes. Post-operatively, the flap can shift, wrinkle (striae), or develop epithelial ingrowth (growth of surface cells under the flap), which may require surgical lifting and irrigation of the flap.
Loss of best-corrected vision: in rare circumstances (less than 1 percent), complications such as severe corneal infection (keratitis), corneal scarring, or irregular healing can cause a loss of visual acuity that cannot be corrected with glasses or contact lenses.
Corneal ectasia: a rare but serious progressive thinning and bulging of the cornea (similar to keratoconus) that can cause severe loss of vision. Ectasia may require rigid gas permeable contact lenses, corneal cross-linking, or corneal transplantation.

Expected Benefits

The primary expected benefit of refractive surgery is a significant reduction in your dependency on eyeglasses or contact lenses, with most patients achieving 20/20 vision or better. For many individuals, this increases visual freedom during daily activities, sports, and occupational tasks. However, it is important to note that refractive surgery does not prevent or correct presbyopia, which is the natural age-related loss of close-up reading vision that typically begins around age 40, meaning you may still require reading glasses.

Reasonable Alternatives to Surgery

Continued use of corrective eyeglasses or standard contact lenses, which carry no surgical risk.
Photoreactive Keratectomy (PRK): a surface ablation procedure where the corneal epithelium is removed and not replaced, eliminating flap-related risks but requiring a longer healing period and associated with more early post-operative discomfort.
Phakic Intraocular Lens (ICL) implantation: surgical placement of an implantable lens behind the iris, suitable for high degrees of myopia or thin corneas where laser reshaping is contraindicated.
No treatment: choosing to remain with your current refractive status and corrective method.

Right to Refuse or Withdraw Consent

You have the right to refuse this procedure or withdraw your consent at any time before the procedure begins without penalty or adverse effect on your medical care. Your surgeon will discuss alternative vision correction methods with you if you choose not to proceed.

Questions and Understanding Confirmation

I confirm that I have had the opportunity to read this consent form and ask questions of my refractive surgeon. I understand that a guarantee of perfect 20/20 vision cannot be made, and that I may require reading glasses as I age. I believe I am making an informed and voluntary decision.

Language Access and Interpreter Services

If English is not your primary language or if you require assistance communicating, a qualified medical interpreter is available to you at no cost. Please notify your care team if you require interpreter services before signing this document.

Copy of Consent Acknowledgment

I acknowledge that I have been offered a signed copy of this informed consent form for my own records. I understand I may request an additional copy at any time from the facility or clinical records department.

Patient Authorization

I have been fully informed about the LASIK / LASEK procedure, its expected benefits, the material risks listed above, and available alternatives. I consent to proceed with refractive surgery on the target eye(s) indicated above and authorize the surgeon and team to perform all necessary procedures to ensure safety and target refractive outcome.

Signatures and Verification

Patient / LAR Signature
Surgeon Signature
Witness Signature
Date and Time of Consent
Document ID: CC-PENDING
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