Consent Forms
Welcome to OMIC’s Consent Form library, a collection of procedure-specific consent forms that you can modify to suit your practice and patient population. Contact riskmanagement@omic.com with questions.
Found
44
resources.
Dec 1, 2002
| Consent Form
...list all risks and complications that may occur. The main risks and complications of [procedure/treatment]PRK are: PRK in eyes with more than 4 D of astigmatism: I understand that the FDA approval of the excimer laser for PRK was based on attempting to correct eyes with no more than 4...
Oct 9, 2014
| Consent Form
...your doctor can determine if you should have PRK surgery based upon your own visual needs and medical considerations. Any questions you have regarding PRK or other alternative therapies for your case should be directed to your doctor. ALTERNATIVES TO PRK SURGERY: The alternatives to PRK include, among others, eyeglasses,...
Oct 9, 2014
| Consent Form
...the above risks and benefits of bilateral simultaneous PRK, and I understand that this summary does not include every possible risk, benefit and complication that can result from bilateral simultaneous PRK. My doctor has answered all of my questions about the PRK procedure. I wish to have both of my...
Oct 9, 2014
| Consent Form
...moderate to high myopia. PRK and LASIK do not require an incision into the inside of the eye as does phakic implant surgery. Photorefractive Keratectomy (PRK) uses an excimer laser to reshape the cornea to refocus light rays on the cornea. PRK may be used to correct low to higher...
Apr 12, 2012
| Consent Form
...records of its use and effects. [State purpose of the off-label drug/device.] [State alternatives to the off-label drug or device.] [State known complications and side effects of the off-label drug/device.] I understand that [state drug/device] was approved by the FDA for [state approval purpose/conditions]. Nevertheless, I wish to have [state...
Mar 9, 2023
| Consent Form
...treat eye conditions in adults. When drugs are used for a purpose that the FDA did not specifically approve, it is called using the drug “off-label.” In 2006, ophthalmologists started using anti-VEGF medications off-label to treat babies with ROP. Ophthalmologists continue to study how well anti-VEGF works to treat ROP...
Apr 16, 2012
| Consent Form
...2. The excimer laser can be used to correct low to moderate amounts of hyperopia (generally +1 to +5 D or diopters) and low to higher amounts of myopia (generally -1 D to –12D) through either PRK (photorefractive keratectomy) or LASIK (laser in situ keratomileusis). LASIK is an operation which...
Oct 9, 2014
| Consent Form
...eyeglasses, contact lenses, orthokeratology (ortho-K), radial keratotomy (RK), intracorneal ring segments (ICRS), holmium laser thermokeratoplasty (LTK), or photorefractive keratectomy (PRK). ELIGIBILITY FOR RETREATMENTS The ophthalmologist alone can determine whether or not you are a candidate for retreatment. Several factors determine eligibility. LASIK retreatment procedures are performed by lifting the corneal...
Oct 9, 2014
| Consent Form
...of vision correction exist, including eyeglasses, contact lenses, orthokeratology (ortho-K), radial keratotomy (RK), intracorneal ring segments (ICRS), holmium laser thermokeratoplasty (LTK), or photorefractive keratectomy (PRK). ELIGIBILITY FOR RETREATMENTS The ophthalmologist alone can determine whether or not you are a candidate for retreatment. Several factors determine eligibility. LASIK retreatment procedures are...
Dec 7, 2012
| Consent Form
...this use is considered “off-label.” That means the U.S. Food and Drug Administration (FDA) did not approve Kenalog for injections inside the eye. Ophthalmologists use Kenalog off-label inside the eye because they have found it can help slow the growth of harmful eye blood vessels and lessen swelling that decreases...
Aug 31, 2016
| Consent Form
...people learn to ignore this second image. Others find it helps to wear prism glasses. · Continued misalignment. Your eyes might not be straight even after surgery. · Altered eyelid position. The upper or lower eyelid of one eye may be at a different height than the other eye. ·...
Oct 9, 2014
| Consent Form
[bookmark: _GoBack]This form is intended as a sample. It does not constitute the standard of care nor does it provide legal advice. It contains the information OMIC recommends the surgeon personally discuss with the patient. How to use this sample · Please modify it to fit your actual practice. ·...
Oct 18, 2019
| Consent Form
...childbearing age if the possible benefit for the woman is greater than the potential risk to the fetus. Please see the prescribing information at Review our risk management recommendations on the use of anti-VEGF drugs in adults. This loss prevention document addresses on- and off-label use, preventing endophthalmitis, informed consent...
Oct 8, 2014
| Consent Form
...“Off-Label” To Treat Ectasia Intacs® are intrastromal corneal ring segments available through Addition Technology, Inc. The ophthalmologist inserts one or two small transparent half-rings into the peripheral cornea through a tiny incision. Intacs® are approved by the Food and Drug Administration (FDA) to treat myopia. When the FDA approves a...
Mar 13, 2020
| Consent Form
...not address intravitreal Avastin, as this use is off-label. It also did not address intravitreal Lucentis. To reduce the potential liability for ophthalmologists using anti-VEGF drugs, we feel it is prudent to address this potential risk with pre-menopausal women. Ask them to sign the “possible risk to the fetus” form...
May 10, 2023
| Consent Form
...of being round like a basketball, the cornea is shaped like a football. This can make your vision blurry. Astigmatism can be reduced by a toric IOL, glasses, contact lenses, and refractive surgery (LASIK or PRK). There is also a procedure called a limbal relaxing incision (LRI) that can be...
Aug 27, 2024
| Consent Form
...With astigmatism, the eye is long (like a football). Many people with cataracts have astigmatism. If you have astigmatism, wearing glasses or contact lenses can help you see more clearly. Or you could have surgery (called LASIK or PRK) to change the shape of your eye to correct astigmatism. There...
Mar 13, 2020
| Consent Form
...treat eye problems with Avastin, its use is considered “off-label.” That means the U.S. Food and Drug Administration (FDA) approved Avastin for treating a different disease (in this case, colon cancer), not eye problems. Ophthalmologists now use Avastin off-label because they have found it can help slow the growth of...
Oct 6, 2014
| Consent Form
...minimize the recurrence of pterygium. MMC was first used as anti-cancer drug. Ophthalmologists use MMC for other purposes “off-label” as part of the practice of medicine*. The decision to use MMC is based on the evaluation of the advantages and potential disadvantages in each individual case. WHAT IS AMNIOTIC MEMBRANE...
Aug 25, 2024
| Consent Form
...[PRK]). There is also a procedure called a limbal relaxing incision (LRI), which can be done at the same time as the cataract operation, or as a separate procedure. A LRI is a small cut or incision the ophthalmologist makes into your cornea to make its shape more round. Astigmatic...
Sep 24, 2014
| Consent Form
...being round like a basketball, the cornea is shaped like a football. This can make your vision blurry. In addition to toric IOLs, astigmatism can be reduced by glasses, contact lenses, and refractive surgery (LASIK or PRK). There is also a procedure called a limbal relaxing incision (LRI), which can...
Oct 3, 2014
| Consent Form
...are several reasons why you may need a new cornea: · Complications from LASIK or PRK surgery · Degenerative eye conditions called corneal dystrophies which affect the clarity of the cornea. · Scarring from previous infections, such bacterial, fungal, and viral (e.g. Herpes simplex) infections. · Excessive swelling (edema) of...
Oct 9, 2014
| Consent Form
...an elective procedure. · The alternatives to KeraVision Intacs for correcting nearsightedness include eyeglasses, contact lenses, and other kinds of refractive surgery procedures such as Radial Keratotomy (RK), Photorefractive Keratectomy (PRK) and Laser in situ keratomileusis (LASIK). · KeraVision Intacs will not prevent the development of naturally occurring eye problems...
Oct 9, 2014
| Consent Form
...you have obtained informed consent. 1. Keep the original in the patient’s medical record. Version 10/09/2014 [bookmark: _GoBack] Mitomycin C with Refractive Surgery “Expanding Roles for Mitomycin C,” Review of Ophthalmology, September, 2002. · Treatment of stromal haze after PRK in patient with BCVA 20/200, reduced to 20/60 uncorrected with...
Nov 15, 2015
| Consent Form
...of childbearing age if the possible benefit for the woman is greater than the potential risk to the fetus. Please see the prescribing information at Review our risk management recommendations on the use of anti-VEGF drugs in adults. This loss prevention document addresses on- and off-label use, preventing endophthalmitis, informed...
Feb 13, 2020
| Consent Form
...Avastin were originally approved by the FDA for cancer treatment. However, physicians can use FDA-approved drugs for other purposes (this is called “off-label” use). These medications should not be used in women who are pregnant, planning to become pregnant, or nursing. Risks (problems glaucoma surgery can cause). As with all...
Feb 13, 2020
| Consent Form
...MMC is approved by the Food and Drug Administration (FDA) for use in eye surgery. 5FU and Avastin were originally approved by the FDA for cancer treatment. However, physicians can use FDA-approved drugs for other purposes (this is called “off-label” use). These medications should not be used in women who...
Feb 13, 2020
| Consent Form
...the most commonly used anti-scarring medications. MMC is approved by the Food and Drug Administration (FDA) for use in eye surgery. 5FU and Avastin were originally approved by the FDA for cancer treatment. However, physicians can use FDA-approved drugs for other purposes (this is called “off-label” use). These medications should...
Feb 12, 2020
| Consent Form
...called “off-label” use). These medications should not be used in women who are pregnant, planning to become pregnant, or nursing. Benefits (ways this surgery might help). The goal of a trabeculectomy is to lower the eye pressure and help you keep the vision you have now. It will not bring...
Feb 21, 2020
| Consent Form
...were originally approved by the FDA for cancer treatment. However, physicians can use FDA-approved drugs for other purposes (this is called “off-label” use). These medications should not be used in women who are pregnant, planning to become pregnant or nursing. Benefits (ways the surgery can help). The goal of Xen...
Mar 13, 2020
| Consent Form
...active, then your uveitis could get worse. You could have more vision loss or even blindness. · Other medications approved by the Food and Drug Administration (FDA) for treating your type of eye problem. · Other medications approved by the FDA for a different condition. Ophthalmologists use these medications “off-label”...
Mar 19, 2023
| Consent Form
...more vision loss or even blindness. Other medications approved by the FDA for treating your type of eye problem. Other medications approved by the FDA for a different condition. Ophthalmologists use these medications “off-label” because they may be similar or even have a better effect compared to an FDA-approved medication....
Mar 19, 2023
| Consent Form
...eye problem. Other medications approved by the FDA for a different condition. Ophthalmologists use these medications “off-label” because they may be similar or even have a better effect compared to an FDA-approved medication. Your ophthalmologist will tell you how these medications could help and the risks (problems) they might cause....
Mar 13, 2020
| Consent Form
...not address intravitreal Avastin, as this use is off-label. Nor did it address intravitreal Eylea. To reduce the potential liability for ophthalmologists using Eylea, we feel it is prudent to address this potential risk with pre-menopausal women. Ask them to sign the “possible risk to the fetus” form. Here is...
Apr 16, 2012
| Consent Form
...approved injections to improve the appearance of wrinkles in other areas of the face, physicians may perform these “off-label” procedures. There are alternatives to Botox, including no treatment, or medicines or surgery on my facial nerves and muscles. Side effects and complications include but are not limited to: 1. Bruising...
Jul 1, 2015
| Consent Form
...the suction could open up the old wound. If the flap or the wound is opened up or moved, this could cause leaking, astigmatism, or scarring. The use of the FS laser on patients who have had refractive surgery is considered “off-label.” This means that the U.S. Food and Drug...
Feb 13, 2020
| Consent Form
...approved by the FDA for cancer treatment. However, physicians can use FDA-approved drugs for other purposes (this is called “off-label” use). These medications should not be used in women who are pregnant, planning to become pregnant or nursing. Risks (problems the surgery may cause). As with any surgery, there are...
Aug 4, 2020
| Consent Form
...unknown. OMIC position on “off-label” use There are no underwriting conditions of coverage or restrictions that apply to this medication (the only medications with such conditions are anti-VEGF agents used to treat ROP). OMIC has consistently supported off-label use and encouraged our policyholders to use their professional judgment on which...
Mar 28, 2022
| Consent Form
...quickly get worse. You could have more vision loss or even blindness. Other medications approved by the Food and Drug Administration (FDA) for treating your type of eye problem. Other medications approved by the FDA for a different condition. Eye surgeons use these medications “off-label” because they can help slow...
Mar 19, 2023
| Consent Form
...use these medications “off-label” because they may be similar or even have a better effect compared to an FDA-approved medication. Your ophthalmologist will let you know if other medications, or a similar medication with a different method of delivery, are available for your condition; whether laser or other types of...
Mar 13, 2020
| Consent Form
...Drug Administration (FDA) for treating your type of eye problem. · Other medications approved by the FDA for a different condition. Ophthalmologists use these medications “off-label” because they can help slow the growth of harmful eye blood vessels and lessen swelling that decreases vision. Anesthesia What type of anesthesia is...
Oct 31, 2024
| Consent Form
...these medications “off-label” because they can help slow the growth of harmful eye blood vessels and lessen swelling that decreases vision. Your eye surgeon will tell you how these other treatments could help and the risks (problems) they might cause. The goal of the SUSVIMO device is to deliver (VEGF...
Oct 6, 2014
| Consent Form
...the safety and effectiveness of treating facial areas other than the nasolabial folds has not been studied; however, Restylane® has been used to enhance the appearance of lips in over 60 other countries. This “off-label” aspect of the treatment has been explained to me. Alternatives. There are alternatives to Restylane®...
Oct 25, 2023
| Consent Form
...Other medications approved by the FDA for treating your type of eye problem. Other medications approved by the FDA for a different condition. (This is called an “off-label” use of a medication.) Your ophthalmologist will tell you how these medications could help and the risks (problems) they might cause. Consent...
These are sample forms—download, review and revise as needed.