Therapeutic Use of Intacs® for Keratoconus Or Ectasia

Therapeutic Use of Intacs® For Keratoconus or Ectasia

Anne M. Menke, R.N., Ph.D. OMIC Risk Manager

DISCLAIMER Recommendations presented here should not be considered inclusive of all proper methods of care or exclusive of other methods of care reasonably directed to obtain the same results. The ultimate judgment regarding the propriety of any specific procedure or treatment must be made by the ophthalmic in light of the individual circumstances presented by the patient. This information is intended solely to provide risk management recommendations. It is not intended to constitute legal advice and should not be relied upon as a source for legal advice. If legal advice is desired or needed, an attorney should be consulted. This information is not intended to be a modification of the terms and conditions of your OMIC policy of insurance. Please refer to your OMIC policy for these terms and conditions.

Version 5/12/06

Intacs® are intrastromal corneal ring segments available through Addition Technology, Inc., and FDA-approved for the treatment of myopia. Although initially approved for elective refractive surgery, some ophthalmologists use them as a therapeutic treatment for ophthalmic conditions such as keratoconus or post-refractive surgery ectasia.

Keratoconus Keratoconus is a degenerative corneal disease affecting vision that is characterized by generalized thinning and cone-shaped protrusion of the central cornea, usually in both eyes. In July, 2004, the FDA approved Intacs® as a humanitarian use device (HUD) for the treatment of astigmatism and myopia in patients with keratoconus who have become intolerant of contact lenses and would otherwise need a corneal transplant for treatment. Before the FDA approval as a HUD, Intacs® were used “off-label” for the treatment of myopia and astigmatism in patients with keratoconus. The purpose of inserting Intacs® in patients with keratoconus is to reduce some of the irregular astigmatism in order to make the cornea more regular and enable the patient to successfully wear soft or hard contact lenses. While insertion of Intacs® may also achieve some reduction in the patient’s myopia, this is considered a side benefit rather than the purpose of the procedure.

Post-Refractive Surgery Myopia and Ectasia Following LASIK or other refractive surgical procedures, some patients develop myopia (nearsightedness) accompanied by ectasia, a forward bulging of the cornea. The purpose of inserting Intacs® in patients with ectasia is to reduce the myopia and /or alter the shape of the cornea to allow the fitting of a contact lens. Intacs® cannot fully correct the myopia and ectasia or return the cornea to a normal state.

OMIC Underwriting Coverage Issues While coverage for all refractive surgery is excluded under the OMIC policy, the insertion of Intacs® for the treatment of keratoconus or ectasia is considered a therapeutic, not a refractive, procedure. Coverage is automatically extended for this therapeutic procedure; no application or policy endorsement is required. • Intacs® for the treatment of myopia (including myopia in patients with keratoconus) is only covered under the OMIC policy if the physician is specifically approved for it and an endorsement is issued. Please contact the Underwriter in your state to apply, or get an application at http://www.omic.com/ . The consent form can be accessed at http://www.omic.com/ .

Patient Selection Criteria/Consent Issues for Therapeutic Use of Intacs® To qualify for the treatment of Intacs® for therapeutic use, patients should meet the following eligibility criteria: • Patients should be contact-lens intolerant. • Patients should have clear central corneas or only minimal central scarring. (Patients with central scarring should be advised of the risks and/or side effects they may experience as a result of their scarring.) • Patients should have corneal thickness of 450 microns or more at the sides of the segments. • Patients should have only PKP as an option to improve vision. • Patients with keratoconus should be informed that the procedure is likely to only temporize the progression of the cone and that a PKP for definitive therapy may eventually be required. This should be documented in the consent form and medical records. o See below on how to acquire a sample consent form for keratoconus • Patients with ectasia should be informed that the procedure cannot fully correct the myopia and ectasia or return the cornea to a normal state. o The OMIC website has a sample consent form.

Use of Intacs® for Keratoconus as a Humanitarian Use Device As stated above, in July, 2004, this device was approved by the Food and Drug Administration (FDA) as a humanitarian use device (HUD) for the reduction or elimination of myopia and astigmatism in patients who have keratoconus who are no longer able to achieve adequate vision with their contact lenses or spectacles, so that their functional vision may be restored and the need for a corneal transplant procedure may potentially be deferred. While considered safe, the effectiveness of Intacs® for the treatment of keratoconus has not been proven.

According to the FDA, a HUD is a device that is "intended to benefit patients in the treatment and diagnosis of diseases or conditions that affect fewer than 4,000 individuals in the United States." Before using Intacs® as a HUD, the physician must obtain the approval of an Institutional Review Board or IRB. A national IRB has been established through Integ

Review, Inc. for this purpose (www.integreview.com or 512.326-3001, ext. 214). Alternatively, physicians may establish their own IRB or use one at the surgical facility.

Resources and Consent Form for Intacs® for Keratoconus as a Humanitarian Device • The manufacturer has developed a the web site (www.keratoconussolutions.com) to assist physicians. On it, physicians register for a username and password which gives them access to the Physician and Patient Information Booklets, postoperative care instructions, how to get IRB approval, and a sample consent form.

Use of Intacs® for Keratoconus or Ectasia as an “Off-Label” Device Although OMIC strongly recommends that treatment of keratoconus with Intacs® be performed under the HDE, coverage will continue to be available through OMIC as an “off- label” procedure. Treatment of ectasia with Intacs® is an “off-label” procedure. Patients should be informed of and understand the “off-label” status of the procedure and the discussion should be clearly documented in the patient’s medical records and consent form. The following information should be conveyed to the patient: • Based upon the results of clinical trials that demonstrated its safety and effectiveness, the Food and Drug Administration (FDA) approved the ophthalmic device, Intacs® prescription inserts, for commercial distribution for the treatment of nearsightedness (myopia). As a condition of approval, the manufacturer, Addition Technology, produced a "label" explaining the indications, risks, and benefits. • Once a device has been approved for commercial distribution for one condition, physicians may use it "off-label" to treat an individual patient with a different condition as part of the practice of medicine if: o They are well informed about the product o Base its use on firm scientific method and sound medical evidence o Keep records of its use and effects. • Patients with keratoconus must also receive an explanation of the approval as a HDE, described above. • OMIC has developed a sample consent form for Intacs® for ectasia which can be accessed at http://www.omic.com/.

OMIC policyholders who have additional questions or concerns about practice changes are invited to call OMIC’s confidential Risk Management Hotline at (800) 562-6642, extension 641.