CATARACT AND LASER CENTER, LLC Patient Information Date: Patient Name: M F Address: Street City State Zip Home Phone: Work Phone: Cell Phone: E-Mail : Referred by: Medical Doctor: Who is your regular eye doctor? Date of Last Eye Exam: Did he/she tell you about us? YES NO Occupation: Employer s Name: Date of Birth: Marital Status: Single Married Widowed Other Emergency Contact: Phone: How did you hear about us? Please be specific and list all sources that apply. List Publication Friend/Patient (list name) Internet Radio/TV (list station) Other (be specific) Medicare Information Medicare ID#: Medicaid ID#: Other Insurance Information Name of Insurance: Insurance ID#: Insurance Group #: Cardholders Name (If other than yours): Cardholder s date of Birth: Social Security Number:
CATARACT AND LASER CENTER, LLC PRIVACY AUTHORIZATION FORM Our Notice of Privacy Practices provides information about how we may use and disclose protected health information about you. The Notice contains a Patient Rights section describing your rights under the law. You have the right to review our Notice before signing this Consent. The terms of our Notice may change. If we change our Notice, you may obtain a revised copy by contacting our office. You have the right to request that we restrict how protected health information about you is used or disclosed for treatment, payment or health care operations. We are not required to agree to this restriction, but if we do, we shall honor that agreement. By signing this form, you consent to our use and disclosure of protected health information about you for treatment, payment and health care operations. You have the right to revoke this Consent, in writing, signed by you. However, such a revocation shall not affect any disclosures we have already made in reliance on your prior consent. The Practice provides this form to comply with the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The patient understands that: Protected health information may be disclosed or used for treatment, payment or health care operations, including appointment reminders by postcard or messages on an answering machine. The Practice has a Notice of Privacy Practices and that the patient has the opportunity to review this Notice. The Practice reserves the right to change the Notice of Privacy Policies. The patient has the right to restrict the uses of their information but the Practice does not have to agree to those restrictions. The patient may revoke this Consent in writing at any time and all future disclosures will then cease. I authorize the release of information to the following person(s): Name Relationship Signed by: Date:
Eye Care of Delaware LASIK Questionnaire Name: Daytime Phone Number: Appt. Date: Current Age: Have you ever been screened for LASIK? No Yes If yes, were you told you were a good candidate? Do you wear?: (check all that apply) Soft Contact Lenses Gas Permeable Hard Lenses Glasses If you wear contact lenses, when was the last time you wore them: If you wear contact lenses, have you had any problems? No Yes, please explain Who is your eye doctor?: Date of last eye exam: Medical History Have you had any prior eye surgery? No Yes Have you had any eye problems? (check all that apply) Dry Eyes Cataracts Retinal Glaucoma Other: Please list all medical conditions: High Blood Pressure Diabetes Autoimmune Disease Pregnant or Nursing List any medications, eye drops, herbal supplements, and vitamins you are currently taking: List any drug allergies you may have: I have no known drug allergies What are your expectations from LASIK? Notes/Questions you have for the doctor:
PATIENT CONSENT FOR MEDICAL RECORDS MAINTENANCE I, (print name), am a patient of Mid-Atlantic Retina, Neuro-Ophthalmologic Associates, P.C., Eye Care of Delaware and understand that: Mid-Atlantic Retina, Neuro-Ophthalmologic Associates, P.C., and Eye Care of Delaware, L.L.C. share an office located at 4102 Ogletown-Stanton Road, Suite 1, Newark, Delaware 19713. For logistical reasons, the practices have agreed to a medical records storage arrangement, whereby the medical records of Mid-Atlantic Retina, Neuro- Ophthalmologic Associates, P.C., patients will be stored within the patient s Eye Care of Delaware, L.L.C. medical record maintained at the office located at 4102 Ogletown- Stanton Road, Suite 1, Newark, Delaware 19713. I understand that this medical records storage arrangement means that my protected health information created by Mid Atlantic Retina and/or Neuro-Ophthalmologic Associates, P.C., will be disclosed to the medical staff and employees of Eye Care of Delaware, L.L.C. Unless otherwise permitted by law, Eye Care of Delaware, L.L.C. may access or use my physical medical record or protected health information only for activities reasonably required under this medical records storage arrangement. I understand that Eye Care of Delaware will be responsible for making my Mid Atlantic Retina and/or Neuro-Ophthalmologic Associates, P.C., records available to me in accordance with federal and state law. Mid-Atlantic Retina/ Neuro-Ophthalmologic Associates, P.C., provides this form to comply with HIPAA. By signing this form, I consent to this arrangement. I acknowledge that I have the right to revoke this Consent, in writing, signed by me. However, such a revocation shall not affect any disclosures Mid-Atlantic Retina/ Neuro-Ophthalmologic Associates, P.C., has already made in reliance on my prior consent. Signed by: Date: 51680825v1
CATARACT AND LASER CENTER, LLC Consent for the use of the Excimer Laser for Performing Photorefractive Keratectomy (PRK) / Laser In Situ Keratomileusis (LASIK)/ CustomVue LASIK (circle one) You are entitled to be informed about the proposed PRK/LASIK/CustomVue LASIK treatment for myopia (nearsightedness), hyperopia (farsightedness), either with or without astigmatism or mixed astigmatism, including the risks of the treatment and the alternatives. Please read this document thoroughly and discuss the content with your doctor, so that all of your questions are answered to your satisfaction. This information is provided, so that you can make an informed decision regarding the use of the excimer laser and microkeratome - the instrument used to create a corneal flap -- to treat your myopia, hyperopia, either with or without astigmatism or mixed astigmatism. Photorefractive Keratectomy (PRK) uses the excimer laser, which produces an intense beam of light that removes the outer layer of corneal (eye) tissue. Laser in situ Keratomileusis (LASIK) is a procedure that uses a microkeratome to create a corneal flap on the surface of the eye to access the middle layer of the cornea to apply the excimer laser to thereby remove the corneal tissue. CustomVue LASIK is a procedure that uses a microkeratome to create a corneal flap on the surface of the eye to access the middle layer of the cornea to apply the excimer laser, guided by the wavescan measurement, to thereby remove the corneal tissue. Due to the elective nature of your procedure, the facility declines to carry out instructions as set forth in any advance directives. I consent to the administration of anesthesia and the use of such anesthetics or medications as may be deemed advisable, including: Topical Anesthesia: Potential risks may include redness, stinging, burning or rash. Local Anesthetics Block: Potential risks may include allergic reaction, low or high blood pressure, rapid or slow heart rate. I authorize Cataract and Laser Center (CLC) to submit for pathology exam or to dispose of any specimens, tissues or parts taken from my body during the course of this operation for procedure. I understand and give consent for observers for medical education or my personal assistance to be present during my procedure. I authorize CLC to use my medical information without my name for tracking, benchmarking and quality assurance purposes. PATIENT STATEMENT I have myopia, hyperopia, either with or without astigmatism or mixed astigmatism, which requires me to wear corrective lenses in order to see clearly for my daily activities. I have been clearly informed of the alternatives including eyeglasses, contact lenses and other types of refractive surgery. I have decided to undergo and give permission for PRK LASIK CustomVue LASIK I declare that I understand the following information: 1. The goal of PRK, LASIK or CustomVue LASIK is to reduce or eliminate myopia, hyperopia, and/or astigmatism or mixed astigmatism. Page 1 of 4
CATARACT AND LASER CENTER, LLC Consent for the use of the Excimer Laser for Performing Photorefractive Keratectomy (PRK) / Laser In Situ Keratomileusis (LASIK)/ CustomVue LASIK (circle one) 2. RISKS: I understand that as with all forms of treatment, the results in my case cannot be guaranteed. There is NO GUARANTEE that I will completely eliminate my reliance on eyeglasses and/or contact lenses. It is possible that the treatment could result in undercorrection, where some degree of refractive error may remain requiring the use of glasses and/or contact lenses. The treatment may also result in overcorrection, causing refractive error, which may or may not require the use of glasses and/or contact lenses. It is possible that dependence on reading glasses may be required at an earlier age. The treatment may also result in a change of my astigmatism that could require the use of glasses and/or contact lenses. I understand further treatment may be necessary, including a variety of eyedrops, the wearing of glasses and/or contact lenses (hard or soft), or additional treatments including surgery. A. Another risk is the occurrence of infection during the healing of the cornea. The incidence of infection is greater during the first three days; however, healing may take as long as a week or more. After PRK, patients have experienced haze. Haze presents itself in patients as though one were seeing through a dirty window. Haze is not the initial blurriness experienced immediately after the treatment but may become evident in weeks or months to follow. For LASIK, it has been reported through studies, that there are also risks of developing haze. However, the rate of occurrence is very low compared to PRK. B. Scarring may be persistent or infrequently recurring, requiring frequent surgeries and possibly producing loss of visual sharpness of clarity. C. Night glare is very common early on in the healing process. However, higher myopic patients are at a greater risk of permanent glare. D. Blurriness is very common in the healing process. It generally takes three to 10 days to clear. However patients should recognize it may take longer. Full recovery especially from PRK, takes 4 to 6 months and a percentage of patients may take up to 12 months. A small percentage of patients develop irregular corneas that reduce sharpness, clarity, and crispness to their vision. Patients may not be able to read the last two or more lines of the eye chart regardless of corrective lens assistance. E. There is a percentage of risk of LASIK patients experiencing a corneal flap complication. A corneal flap that is too thin may result in postponement of the procedure, prolonged visual recovery and/or temporary or permanent blurred vision. Other potential corneal flap complications include a corneal flap incision, which is too long, resulting in a free flap; this may increase the potential for prolonged visual recovery, blurred vision, and epithelial ingrowth. Corneal flaps that are too short necessitate postponing the procedure. The most potentially serious risk is a corneal flap that is too deep, which results in perforation of the eye, but this is very rare. F. During the first several hours after a LASIK procedure, the epithelial protective layer grows over the corneal flap. There is potential of developing epithelial cell growth underneath the flap. This is more common in people whose natural epithelial protective layer is not adequately attached to the eye surface. G. There is a risk of inducing astigmatism greater than the pretreatment status or appearing in another part of the cornea. 3. I understand that if I need reading glasses prior to treatment, I will likely need reading glasses after this treatment. I also understand that if I do not currently need reading glasses, I may need them at sometime after the surgery. 4. I understand that as with any form of surgery the outcome can never be guaranteed. The benefits of excimer laser therapy also cannot be guaranteed. 5. (FEMALE ONLY) I am not pregnant or nursing. If it is possible that I am pregnant, then I will take a home pregnancy test to ascertain that I am NOT pregnant, since pregnancy could adversely affect my treatment results. If the results of the test are positive, I will NOT undergo treatment until the results are proven Page 2 of 4
CATARACT AND LASER CENTER, LLC Consent for the use of the Excimer Laser for Performing Photorefractive Keratectomy (PRK) / Laser In Situ Keratomileusis (LASIK)/ CustomVue LASIK (circle one) incorrect or I will reschedule the treatment after I am no longer pregnant or nursing. If I become pregnant in the six (6) months following treatment, I will notify my eye doctor immediately. 6. I understand that as a result of the treatment there is a risk that my vision may be made worse. 7. I understand that treatment should not be performed on persons with uncontrolled vascular disease or autoimmune disease, or on patients who are immunocompromised or on drugs or therapy which suppress the immune system, so I will tell the doctor if I have any of these or other medical conditions. 8. I understand the treatment should not be performed on persons with signs of keratoconus since eyes with this condition may have unstable corneas. 9. I understand that treatment should not be performed on persons known to have a previous history of keloid formation (excessive scar formation) because their corneal healing response is less predictable. 10. I understand that partially and fully sighted eyes have been treated with the excimer laser in the past. The long term effect associated with the PRK, LASIK or CustomVue LASIK procedures are not fully known. 11. I give permission for the medical data concerning my operation and any subsequent treatment to be submitted for outcome data analysis. I understand that my identity will be kept strictly confidential in any reports or journal articles. 12. I understand that this treatment is an elective procedure and that I do not have to have this treatment. I understand that PRK, LASIK or CustomVue LASIK treatment is not reversible. 13. I understand that PRK, LASIK or CustomVue LASIK treatment requires follow-up care at frequent intervals for one year after treatment and I agree to return for required examinations. IMPORTANT INFORMATION The three forms of Laser Vision Correction known as PRK, LASIK, and CustomVue LASIK are permanent operations to the cornea; it cannot be reversed. Alternatives to PRK, LASIK, and CustomVue LASIK include glasses, contact lenses, RK, Conductive Keratoplasty and Intraocular Lenses. PRK, LASIK, and CustomVue LASIK are NOT laser versions of radial keratotomy (RK); they are completely different from one another. Refractive error must be stable (within +/-0.5D) for at least one year before the surgery. The following risks of Laser Vision Correction (PRK/LASIK/CustomVue LASIK) surgery should be noted: Transient complications: pain (24-48 hours), corneal swelling, double vision, feeling something in the eye, shadow images, light sensitivity, tearing and pupil enlargement. These problems may last up to several weeks. Adverse events: night vision difficulty (1%); elevation of intraocular pressure (2%); cloudy cornea affecting vision (2%); overcorrection or become farsighted (5%); undercorrection or still nearsighted (6%); loss of best vision that can be achieved with glasses (7%); mild halo (10%); and, minor glare (10%). If both eyes are treated on the same day, there may be some additional associated risks such as infection. The following benefits of Laser Vision Correction surgery should be noted: Nearsightedness, Farsightedness, and/or Astigmatism may be reduced so that the amount of time during the day contact lens or eyeglasses are used is reduced or eliminated. Laser Vision Correction may be an alternative to eyeglasses in some patients who are intolerant of contact lenses. Another alternative to correct nearsightedness, farsightedness, and/or astigmatism or mixed astigmatism. Page 3 of 4
CATARACT AND LASER CENTER, LLC Consent for the use of the Excimer Laser for Performing Photorefractive Keratectomy (PRK) / Laser In Situ Keratomileusis (LASIK)/ CustomVue LASIK (circle one) Patients considering Laser Vision Corrective surgery should: Discuss fully with one or more eye doctors the complications of surgery, the risks and the time required for healing, and have a complete eye examination before making a final decision. Please read this Patient Informed Consent Document carefully before signing. STATEMENT OF VOLUNTARY PARTICIPATION In signing this Informed Consent Form for Photorefractive Keratectomy (PRK), Laser in situ Keratomileusis (LASIK), or CustomVue LASIK I am stating that I have read this Informed Consent (or it has been read to me) and I fully understand it and the possible risks, complications and the benefits that can result from the treatment. Although it is impossible for the doctor to inform me of every conceivable complication that may occur, the doctor has answered all of my questions to my satisfaction. I understand that if I have any questions with respect to the treatment, I can call my physician. By signing this form, I acknowledge that I understand the following: 1. The Photorefractive Keratectomy (PRK) treatment has been explained to me in terms that I understand; 2. The Laser in situ Keratomileusis (LASIK) treatment has been explained to me in terms that I understand; 3. The CustomVue Laser in situ Keratomileusis (LASIK) treatment has been explained to me in terms that I understand; 4. I have had the opportunity to have my questions answered; and 5. I fully understand the possible risks, complications and benefits that can result from treatment. MY DECISION TO UNDERGO THE PHOTOREFRACTIVE KERATECTOMY (PRK), LASER IN SITU KERATOMILEUSIS (LASIK) or CustomVue LASER IN SITU KERATOMILEUSIS (LASIK) FOR NEARSIGHTEDNESS, FARSIGHTEDNESS, WITH OR WITHOUT ASTIGMATISM TREATMENT HAS BEEN MY OWN AND HAS BEEN MADE WITHOUT DURESS OF ANY KIND. Eye to be treated: Right Eye (OD) Left Eye (OS) Both (OU) Patient's Name (Type or Print) Patient's Signature Physician's Signature Witness' Signature Date Date Date Page 4 of 4