AK Consent Form

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NOTE:  THIS FORM IS INTENDED AS A SAMPLE FORM.  IT CONTAINS THE INFORMATION OMIC RECOMMENDS YOU AS THE SURGEON PERSONALLY DISCUSS WITH THE PATIENT.  PLEASE REVIEW IT AND MODIFY TO FIT YOUR ACTUAL PRACTICE.  GIVE THE PATIENT A COPY AND SEND THIS FORM TO THE HOSPITAL OR SURGERY CENTER AS VERIFICATION THAT YOU HAVE OBTAINED INFORMED CONSENT.

Version 06/01/03

INFORMED CONSENT FOR ASTIGMATIC KERATOTOMY (“AK”)

Introduction

This information, including the benefits, alternatives, and possible complications of surgery, is being provided to you so that you can make an informed decision about having astigmatic keratotomy (“AK”) to treat your astigmatism.  You are encouraged to ask questions about any procedure and have them answered to your satisfaction before agreeing to have the operation.  Take as much time as you need to make your decision.

Astigmatic keratotomy is a surgical procedure which consists of making fine microscopic arcuate (curved) incisions, either singly or as a pair at optical zones of either 6 or 7 mm, or relaxing incisions at the limbus, which is the junction of the clear part of the eye (cornea) with the white (sclera) of the eye.  These cuts are made for the purpose of flattening the steepest part of the cornea in an attempt to obtain a more spherical cornea.  AK permanently changes the shape of the cornea.  Although the goal of AK is to improve vision to the point of not wearing glasses, this result is not guaranteed.

AK is an elective procedure:  There is no emergency condition or other reason that requires or demands that you have it performed.  You could continue wearing contact lenses or glasses and have adequate visual acuity.  This procedure, like all surgery, presents some risks, many of which are listed below.  You should also understand that there might be other risks not known to your doctor that may become known later.  Despite the best of care, complications and side effects may occur; should this happen in your case, the result might be affected even to the extent of making your vision worse.

Alternatives to AK

If you decide not to have AK, there are other methods of correcting your astigmatism.  These alternatives include, among others, eyeglasses, contact lenses, and other refractive surgical procedures such as PRK or LASIK.

PATIENT CONSENT

I give my consent to my ophthalmologist to perform AK, and I declare that I understand the following: I have received no guarantee as to the success of my particular case.  I understand that the following risks are associated with the procedure:

Potential Risks and Complications

I understand that there is a possibility that my vision may not improve with this surgery or that the desired results of surgery may not be obtained.  It is possible that I may require additional surgery at a later date or that I could still need glasses after surgery.  It is possible that I may not be able to wear contact lenses after having this surgery.

As a result of the surgery, it is possible that I could lose vision or lose best-corrected vision.  This could happen as a result of infection that could not be controlled with antibiotics or other means, which could even cause loss of my eye.

Irregular healing of incisions may cause the corneal surface to be distorted.  In that case, it may be necessary for me to wear a contact lens to affect useful vision, and there is a possibility that this may not restore useful vision.

I understand that I may experience incapacitating light sensitivity from sunlight or other bright light sources for a varying length of time, or possibly permanently.

I understand that I may experience incapacitating glare or halos from oncoming headlights or other bright light sources, particularly in the evening or nighttime, for a varying length of time or possibly permanently.  I am aware that this may interfere with driving for an indefinite period both day and night, and I understand that I am not to drive until I am certain that my vision is adequate both day and night.

I understand that fluctuations or variation in vision may occur during the day during the initial stabilization period (up to three months or longer).

As occurs in all surgical procedures, scarring is the result of making incisions in living tissue.  This particular surgery is no exception.

My eye will be more susceptible to a blow to the eye during the healing phase and possibly somewhat after healing as the microscopic scar tissue may not be as strong as the normal tissue.  Protective eyewear is recommended for all contact and racquet sports where a direct blow to the eye could cause permanent injury to the eye.

Additional reported complications include corneal perforation, which could possibly require sutures; incisional inclusions, corneal vascularization, corneal ulcer formation, endothelial cell loss, epithelial healing defects, and very rarely, endophthalmitis (internal infection of the eye, which could lead to permanent loss of vision).

I understand that, as with all types of surgery, there is a possibility of complications due to anesthesia, drug reactions or other factors that may involve other parts of my body.  I understand that, since it is impossible to state every complication that may occur as a result of any surgery, the list of complications in this form may not be complete.

PATIENT’S STATEMENT OF ACCEPTANCE AND UNDERSTANDING

The details of the procedure known as AK have been presented to me in detail in this document and explained to me by my ophthalmologist.  My ophthalmologist has answered all my questions to my satisfaction.  I have read this informed consent form (or it has been read to me), and I fully understand it and the possible risks, complications, and benefits that can result from surgery.  I therefore consent to AK surgery.

I wish to have AK performed on my          right             left eye.

Patient (or person authorized to sign for patient)                        Date

Witness                                                    Date

I have been offered a copy of this consent form (patient initials) ________

Coverage for Use of Premium IOLs

By Kimberly Wittchow

OMIC Legal Counsel

Digest, Winter 2009

While use of premium intraocular lens implants (IOLs) does not directly impact your policy coverage with OMIC, you should be aware of the policy provisions and underwriting requirements related to the use of IOLs and how they might vary for premium IOLs. There are two scenarios in which premium IOLs might be employed. The first is refractive lens exchange (RLE) surgery and the second is cataract surgery.

Refractive Lens Exchange

OMIC uses the term refractive lens exchange for refractive surgery in which IOLs (premium or otherwise) are used to replace a patient’s natural lens in order to improve vision when visually significant cataracts are not present. All refractive surgery is excluded under the policy unless specifically added back on by endorsement.

If you seek coverage for refractive lens exchange, you must fill out a supplemental questionnaire and submit it to the underwriting Department for review. In applying, you agree to abide by OMIC’s general refractive surgery and specific RLE requirements.

If approved, an endorsement will be placed on your policy, adding coverage back for this procedure at full policy limits. (No additional premium is required.) This endorsement specifies that RLE is covered, but only when performed within OMIC’s underwriting requirements or any exceptions to the requirements granted in writing by OMIC. If you seek an exception to the requirements, you may do so in writing to your underwriter by completing the Exception Request Form. OMIC discourages exceptions except in extenuating circumstances and only grants exceptions on a patient- specific basis. Do not schedule surgery until your exception is granted.

RLE Underwriting Requirements

To see all of the refractive surgery and RLE-specific underwriting requirements, see the Guide to Refractive Surgery Requirements. These requirements, along with the RLE supplemental application, address patient selection criteria, informed consent, operative procedures, postoperative care, and advertising.

One specific requirement to note is that RLE must take place in a hospital or outpatient surgical facility approved for cataract surgery and full sterile technique must be followed. RLE may not be performed in a physician’s office, laser refractive center, or other facility that does not meet the standard for sterile conditions required for accreditation.

Other requirements specific to RLE are: (1) there must be an interval of at least a week between primary procedures, (2) all patients must undergo a retinal exam pre- and postoperatively and be advised of the increased risk of retinal detachment, and (3) patient selection guidelines for myopia and hyperopia (treatment of emmetropic patients is not covered) must be followed (see box).

The use of premium versus standard IOLs in RLE procedures does not make a difference as far as coverage is concerned, as long as, in using them, no underwriting requirements are violated. You are, though, required to address the specific IOL to be used in the informed consent process and explain its indications, risks, benefits, alternatives, and complications, as well as its off-label use for RLE.

Cataract Surgery

If the patient has selected the use of premium IOLs in cataract treatment, no special underwriting is required. Remember that a procedure is considered refractive surgery if the lens is completely clear or there are visible cataract changes that aren’t visually significant and not associated with patient complaints about vision. Cataract surgery is automatically covered under the policy (under surgery class 3). As long as the use of premium IOLs is within OMIC’s general policy requirements, no endorsement is required.

You should also note that the policy excludes coverage of clinical research or trials that are not conducted under and in accordance with an American IRB-approved protocol. Make sure that any premium IOL clinical trials you are involved in meet these standards in order to ensure coverage under your OMIC policy.

RLE UNDERWRITING REQUIREMENTS

Myopia. Patients must be presbyopic, age 40 or older, and have at least 6 diopters and not more than 15 diopters of myopia.

Hyperopia. Axial length must be at least 20 mm, and uncorrected visual acuity must be 20/40 or worse. Patients age 40 and older must be presbyopic and have at least 1 diopter and not more than 15 diopters of hyperopia. Patients under age 40 must have at least 4 diopters and not more than 15 diopters of hyperopia.

Refractive Surgery Guidelines Revised

For OMIC’s current refractive surgery requirements (2022), please click here.

Charges of Abandonment by Noncompliant Patient

Digest, Spring, 1992

ALLEGATION  Insured ophthalmologist was charged with abandonment by a patient after terminating care due to poor compliance with treatment.

DISPOSITION  Insured wrote off the patient’s bill. No payment was made by the insurance carrier (OMIC).

Background

One of the most difficult things a physician sometimes must do is to terminate the doctor/patient relationship. The decision to terminate a relationship is not only an emotional one but can have medical and legal ramifications as well.

Case Summary

The patient was a 30-year-old female who underwent a radial keratotomy of the left eye by another physician. Postoperatively, the eye resulted in a marked overcorrection with a hyperopia in excess of +12. The patient did not want to wear glasses or contact lenses to correct the problem and was referred to the OMIC insured for evaluation. To help correct the problem, the insured performed a procedure whereby he sutured the radial keratotomy incisions to help stabilize the wound. A detailed informed consent was obtained. Although there was noted improvement in the visual acuity, the patient continued to complain of monocular diplopia, fluctuating vision and photophobia. However, the patient failed to keep several post-op appointments despite letters and telephone calls from the insured stressing the need for follow-up. She was also noncompliant about taking prescribed medication.

The patient elected to see a corneal specialist and the insured transferred the medical record to the specialist and advised the patient that he wished to discontinue serving as her ophthalmologist. The patient threatened legal action if the insured stopped seeing her.

Outcome

The OMIC insured wrote off her bill and the patient did not take legal action. OMIC closed the claim without making any payment. The insured ophthalmologist did several things that were instrumental in minimizing the chance of a lawsuit. First, he discussed the procedure and all possible risks, complications and alternative treatments available to the patient. He obtained a detailed consent form and made no guarantees as to the outcome of the surgery. After the procedure, the insured thoroughly documented in the chart when the patient failed to comply with treatment and followed up with several letters expressing concern and disappointment that she had not kept her appointments. The insured also communicated the need for follow up so that the medications could be adjusted and the cornea monitored for continued healing, and he mentioned the adverse consequences of continued noncompliance. Furthermore, the insured wrote to the patient to advise that he was discontinuing his service as her ophthalmologist and to suggest that she select an ophthalmologist who could continue to care for her. Finally, he wrote off the remainder of the patient’s bill without suggesting there was any improper care or liability.

Risk Management Principles and Commentary

Although there is no guarantee that every ophthalmologist who terminates the doctor/patient relationship will have the same result as this insured, there are some guidelines to follow which may protect one against a claim of abandonment.

• Discuss the procedure with the patient thoroughly and document the risks, complications and alternative methods of treatment;
• Document in detail the patient’s noncompliance with treatment and failure to keep follow-up appointments;
• Write or telephone the patient communicating your concern and the consequences of noncompliance and document that communication;
• Suggest that the patient obtain a second opinion;
• Write to the patient noting the reasons why you are terminating the relationship and recommending that the patient obtain another ophthalmologist for continued care.

A note of caution: In this situation, the patient had already sought the care of a corneal specialist and had requested the ophthalmologist forward the medical records to the specialist. Also, the patient’s condition was not critical. Terminating the relationship did not carry any risk to the patient, which may not be the case in other situations. However, in the absence of a critical condition requiring continued medical attention, terminating a doctor-patient relationship may become necessary in some instances.

Delay in Consultation Referral of Post-RK Patient

Digest, Fall, 1996

Allegation

Improper performance of radial keratotomy (RK) surgery, lack of informed consent, and fraudulent concealment of plaintiff’s condition.

Disposition

Case settled with a small indemnity payment.

Case Summary

The patient was a 28-year-old woman who was nearsighted and had worn contact lenses for a number of years without problems. She was interested in having RK surgery after reading about the procedure in a newspaper article. The patient contacted the insured ophthalmologist and was seen by him in August 1986. The insured discussed RK with the patient and had her watch a video showing how the procedure was performed and covering the risks and benefits of RK surgery. The patient’s right eye was scheduled for surgery in November. Prior to surgery, the patient signed a lengthy RK informed consent document, which included information about possible reoperations (enhancements), loss of night vision from “starburst effect,” and the fact that there were no guarantees as to the success of the procedure. During surgery on the right eye, the third incision resulted in a macroperforation and the procedure was terminated. The left eye was operated on later that month and had an initial good result with vision improving to 20/30. In February 1987, the right eye was operated on again with good results. Vision was 20/30 OD and 20/50 OS when tested in March. A repeat surgery of four incisions on the left eye was performed in April. The left eye was still undercorrected and another four-incision reoperation was done in June. Follow-up visits with the insured as late as December of that year showed vision without correction to be 20/25 OD and 20/60 OS.

The patient experienced a great deal of difficulty driving at night because of the starburst effect, which the insured tried to treat with a combination of miotics, contact lenses, and spectacles without much success. The patient eventually was referred to a corneal subspecialist by her family’s optometrist. The corneal subspecialist made critical comments about the symmetry, depth, and placement of the incisions in the cornea. Three months later, the patient filed a lawsuit against the insured.

Even though the patient’s VA was 20/20-1 OD and 20/20 OS with contact lenses, the subspecialist proposed corneal transplantation (PKP) as a way of relieving the glare, photophobia, and visual distortion the patient was experiencing at night. After consulting with two other ophthalmologists, the patient agreed to have PKP on the right eye in August 1990. The graft was successful, and the patient claimed the PKP had relieved her glare and star-burst effect in the right eye; however, she did not want PKP on the left eye.

Analysis

The expert for the defense was a corneal subspecialist. At his deposition he testified that the insured’s treatment of the patient was appropriate and countered the other subspecialist’s criticisms regarding the depth and placement of the insured’s incisions. He stated that it was difficult to criticize incision depth since it is impossible to determine with certainty the depth of the incision after it has healed. He also testified that the “symmetry of the incisions” may not be important since many patients have good results with incisions that are irregularly placed or wavy. Finally, he testified that corneal transplant surgery was “way down” on his list of possible treatment options for this patient.

The plaintiff’s expert testified at his deposition that the incisions were not of appropriate depth and were well into the visually significant area of the cornea. The subsequent treating ophthalmologist at his deposition simply confirmed his initial critical comments regarding the depth and placement of the incisions and supported his own recommendation for PKP. Although performing PKP on post-RK patients is controversial, the subsequent treating ophthalmologist was supported by the two other ophthalmologists whom the patient had consulted with prior to PKP.

This case was further complicated by the fact that the patient had begun seeing a psychiatrist for depression and suicidal ideation. The mental health notes stated the depression “… began about four years ago when her corneas were permanently damaged from poorly done surgery on her eyes.”

Defense counsel recommended settlement because this state had a history of high jury awards against ophthalmologists in a number of RK cases even when the patient’s complaints involved relatively minor visual problems. Counsel also felt that if a jury believed the patient’s depression was causally (actually) related to the surgery, the insured could be exposed to a potentially large award. The insured took this advice and agreed to settle.

Risk Management Principles and Commentary

Careful patient selection is a prominent issue in this case. Perhaps there is no way the insured could have detected the patient’s “psychological vulnerability” prior to surgery, but it is still important to point out that often patients who have elective surgery, be it refractive surgery or laser skin resurfacing, have unrealistic expectations and tend to blame the surgery and the surgeon when their lives do not change or the results are not as wonderful as they had hoped. Any patient with a history of psychiatric treatment or substance abuse should be given extra attention by the ophthalmologist. This does not mean that such patients should be summarily denied surgery; however, it may be necessary to spend more time with them to clear up any misconceptions.

The most important risk management issue in this case was the delay in referring the patient to a corneal subspecialist. The delay caused two things to occur. First, the insured lost control of the patient, who went to a subspecialist who held a conservative viewpoint on indications for RK surgery and who had already performed several corneal transplants on post-RK patients. Second, the delay, coupled with the criticism of this subspecialist, raised doubts in the patient’s mind about whether the insured had concealed the fact that she needed a corneal transplant to treat the starburst effect. With refractive surgery patients, and others who have had elective surgery, it is important to consider early consultations to subspecialists or colleagues when the patient complains about some aspect of the care or result. These patients often need reassurance that the treatment rendered has been appropriate and, sometimes, the subspecialist or colleague may have a treatment plan that may help or appease the patient. Any suggested alternative treatment by a colleague should be done so the patient understands it is a joint effort between colleagues to help resolve the problem. Finally, keeping control of the consulting process generally will result in a referral to someone who is less likely to criticize the treatment or surgery. This type of prudent referral is not to be mistaken for a conspiratorial cover-up of a real problem, but rather a commitment to work together in search of a proper resolution to the patient’s complaints.