Refractive Lens Exchange
(RLE) Consent Form

FOR REVIEW ONLY Please review this document for your information. Your signature will be required on the date of your procedure.​

PROCEDURE

Refractive Lens Exchange (RLE)

DESCRIPTION OF PROCEDURE

Patients seeking to reduce their dependance on glasses can consider either cornea or lens based correction procedures.  Refractive Lens Exchange (RLE) is a surgical procedure which replace the natural lens of the eye with an artificial lens (intraocular lens or IOL) to correct refractive errors, such as nearsightedness, farsightedness, and presbyopia.

The procedure typically involves the following steps:

• Local anesthesia to numb the eye.

• Making a small incision in the eye.

• Removing the natural lens.

• Inserting and positioning the IOL.

BENEFITS

The goal of this procedure is to:

​

• Reduce or eliminate the need for glasses or contact lenses.

• Improve vision.

RLE will not correct other causes of decreased vision, such as glaucoma, diabetes, or age-related macular degeneration. You may still need to wear glasses after RLE for certain activities, such as reading, or to correct any residual refractive error.

ALTERNATIVES

Alternatives to RLE include:

​

• Eyeglasses or contact lenses

• Laser vision correction (LASIK, PRK): These procedures reshape the cornea to correct vision.

• Observation: If the refractive error is not significantly affecting vision.

I understand that the only way to replace my natural lens with an artificial lens to correct my refractive error is with surgery.

RISKS AND COMPLICATIONS

I understand that, as with any surgical procedure, there are risks and potential complications associated with RLE. These include, but are not limited to:

​

• Common Side Effects

  • Temporary discomfort, itching, or irritation.

  • Temporary blurred vision.

  • Temporary eye redness and swelling.

  • Dry eye symptoms.

  • Sensitivity to light.

  • Need for glasses after surgery.

​​

• Potential Complications

  • Infection inside the eye (endophthalmitis).

  • Bleeding inside the eye.

  • Inflammation.

  • Retinal swelling (macular edema).

  • Retinal detachment.

  • Dislocation or malposition of the IOL.

  • Increased eye pressure (glaucoma).

  • Corneal swelling or clouding.

  • Damage to other eye structures.

  • Double vision.

  • Droopy eyelid (ptosis).

  • Need for further surgery.

  • Loss of vision (rare).

  • Halos, glare, or starbursts around lights, especially at night.

​​

I have been informed about the material risks that are specific to my circumstances, including the potential need for additional procedures or treatments.

ACKNOWLEDGEMENT OF UNKNOWN RISKS

I understand that it is not possible or reasonable to predict or explain every possible risk or complication that may occur.

INTRAOCULAR LENS (IOL) INFORMATION

I understand that an artificial lens (IOL) will be implanted in my eye to replace the natural lens that is removed. The type of IOL has been discussed with me, including the potential benefits and limitations of different IOL options (e.g., monofocal, extended range of vision, toric). I understand that the IOL cannot fully replicate the function of my natural lens. I understand that the IOL power is calculated before surgery, but the final visual outcome is dependent on the healing process of my eye, and I may still need glasses for certain activities.

​

POST-PROCEDURE CARE

I understand that I will need to follow my physician's instructions carefully after the procedure. This may include:

• Using prescribed eye drops.

• Wearing an eye shield, especially at night.

• Avoiding strenuous activity.

• Avoiding rubbing or putting pressure on my eye.

• Attending all scheduled follow-up appointments.

• Reporting any signs of infection or complications promptly. 

​​

AUTHORIZATION OF ADDITIONAL PROCEDURES IN UNFORESEEN CIRCUMSTANCES

I understand that during the procedure, unforeseen or unknown conditions may be discovered that require additional or different procedures than those initially planned. I authorize the above-named healthcare provider, or their designate, to perform such additional procedures that, in their professional judgment, are immediately necessary and desirable to address these conditions, and where delaying such procedures would not be in my best interest.

CONSENT TO ANESTHESIA AND MEDICATIONS

In addition to topical freezing drops, I understand that I may receive sedation for my RLE surgery. The goal is to reduce pain and anxiety and help me remain comfortable and calm. I have been informed that sedation for eye surgeries is generally very safe, and that my vital signs will be monitored throughout the procedure. Complications related to anesthesia, though rare, including cardiac or respiratory problems.

​

I understand that the following sedation options have been discussed:

​

• Oral Sedation (Ativan): I understand that I may receive oral sedation with Ativan. Potential side effects of oral sedation may include drowsiness, dizziness, confusion, and nausea.

• IV Sedation: In some cases, IV sedation may be used. I understand that IV sedation involves administering medication through a vein. I have been informed that IV sedation is generally very safe, and that my vital signs will be monitored throughout the procedure. I understand that I will not be put to sleep. Some rare side effects of IV sedation include, but are not limited to, decreased breathing rate, nausea, vomiting, and dizziness.

• No Sedation: I understand that I have the option to undergo the surgery with only topical freezing drops and no additional sedation.

​​

I acknowledge that the anesthesiologist or my surgeon will assess and provide their recommendation regarding the most appropriate form of anesthesia/sedation for my individual needs. I understand that the final decision regarding the type of sedation will be made in my best interest and safety.

​

I understand that if my medical history is complicated, the anesthesiologist will arrange to see me before my surgery. I also understand that I may request to see my anesthesiologist prior to my surgery for any clarification or information regarding the anesthesia/sedation.

​

CONSENT TO ANESTHESIA AND MEDICATIONS

I consent to the administration of appropriate anesthesia and all other medications deemed necessary to facilitate the treatment.

REGULATORY CONSIDERATIONS

I understand that Refractive Lens Exchange (RLE) may be considered off label in certain circumstances by regulatory agencies, such as Health Canada.

​

CONFIRMATION OF UNDERSTANDING

I acknowledge that I have read and understood the above information presented to me and I have been offered a copy of this consent form.  I have had the opportunity to ask questions about the procedure, its alternatives, risks, and benefits. I agree I have received all of the information to make an informed decision. I voluntarily consent to the Refractive Lens Exchange (RLE) Surgery described above.

​

RIGHT TO WITHDRAW CONSENT

I understand that I have the right to withdraw my consent at any time before the procedure begins.

ACKNOWLEDGEMENT

I acknowledge that no guarantees have been made to me as to the result of the procedure(s).