オルソ ケラトロジービデオ教材は、第１巻、第２巻、
フィッティングマニュアルのセットです。

先生方の強い要望にお答えして、オルソケラトロジー・レンズについてのビデオがVHSテープで完成されました。
第一次として、参考文献をベースに、第１巻と第２巻を次のように制作しました。どうぞご参考にしてください。

第１巻、第２巻と共に（専門医用）処方マニュアルが付いています。
注意：ビデオの著作権は国際法によって保護されております。

制作者の書面上の許可なく下記のことをすることをお断りいたします。

• ビデオの複製、引用、貸し出し
• 公の場で上映すること
• パソコンへの保存、またはデジタル化すること

許可が必要な方は、下記のお問い合わせ先までご連絡ください。

 お問合せ先：

〒351-0033     埼玉県朝霞市浜崎1-2-10   アゴラ21ビル７F      株式会社アイメディ商事   鎌木泰
Tel（048）472-1460　　Fax(048)472-1461        メール：鎌木 (info472@eye-medi.com)

オルソ ケラトロジービデオ教材は、第１巻・第２巻・
フィッティングマニュアルのセットで構成されています。

Bibliography 参考資料・文献

1. Document　文献

• After Your G.P. Specialist’ Rigid Gas Permeable Contact Lenses for Orthokeratology have been Fitted, G. P. Specialist, Phoenix, AZ, USA, 2001
• Buyer Beware, U.S. Department of Health and Human Services Food and Drug Administration
• Corneal Refractive Therapy: Why it’s Not the ‘O’ Word, American Journal of Ophthalmology, Vol.133, No. 4, 2002
• Eyeing Your Prescription, U.S. Department of Health and Human Services　Food and Drug Administration,
• FDA Public Health Notification: Illegal Promotion of Contact Lenses, D. Bruce Burlington, M.D., Center for Devices and Radiological Health U.S. Food and Drug Administration, September 25, 1998
• Guidance for Premarket Submissions of Orthokeratology Rigid Gas Permeable Contact Lenses、U.S. Department of Health and Human Services Food and Drug Administration: Center for Devices and Radiological Health Vitreoretinal & Extraocular Devices Branch Division of Ophthalmic, Ear, Nose and Throat Devices Office of Device Evaluation, April 10, 2000
• Package Insert C.C.C., G.P. Express, Fargo, H.R.E., G. P. Specialist, Phoenix, AZ, USA, 2001
• Premarket Notification (510(K) Guidance Document for Daily Wear Contact Lenses, U.S. Department of Health and Human Services Food and Drug Administration: Center for Devices and Radiological Health Vitreoretinal & Extraocular Devices Branch Division of Ophthalmic, May 12, 1994
• Proper Care Gives Safer Wear, U.S. Department of Health and Human Services Food and Drug Administration
• Professional Fitting and Information Guide, G. P. Specialist, Phoenix, AZ, USA, 2001
• SIGNIFICANT RISK AND NONSIGNIFICANT RISK MEDICAL DEVICE STUDIES (FDA Information Sheets October 1, 1995; This replaces Bluebook Memorandum IDE Memorandum D86-1 (July 25, 1986) with the same title), Program Operation Staffs (HFZｭ403) Office of Device Evaluation Center for Devices and Radiological Health Food and Drug Administration, October 1, 1995
• Summary of Safty and Effectiveness Data, U.S. Department of Health and Human Services Food and Drug Administration, 2002
• What You Should Know as You Consider Orthokeratology (Corneal Reshaping), G. P. Specialist, Phoenix, AZ, USA, 2001
• 専門医用オルソケラトロジー・レンズ処方：Professional Fitting and Information Guide、改訂版、
  鎌木　泰（訳）、有限会社アイメディ商事、埼玉県朝霞市、２００２

2. Panel　会議・学会

• ADVISORY PANEL, Ninetieth Meeting, VOLUME I, February 12, 1998, Miller Reporting Company Inc. Washington, D.C. 20002
• OPHTHALMIC DEVICES PANEL OPEN SESSION, U.S. Department of Health and Human Services　Food and Drug Administration, January 13, 2000
• OPHTHALMIC DEVICES PANEL NINETY-NINTH MEETING, U.S. Department of Health and Human Services Food and Drug Administration, May 11, 2000
• Ophthalmic Devices Panel Meeting Summary for November 8, 2000, DIVISION UPDATES, A. Ralph Rosenthal, M.D. Center for Devices and Radiological Health U.S. Food and Drug Administration, Miller Reporting Company Inc. Washington, D.C. 20002
• SUMMARY MINUTES  OF THE OPHTHALMIC DEVICES PANEL MEETING ONE HUNDRED AND FIRST MEETING, July 20, 2001,

3. Internet Resources　インターネット

• http://www.fda.gov/cdrh/ode/guidance/1134.pdf
• http://www.fda.gov/cdrh/pdf/P870024S043b.pdf.
• http://www.fda.gov/cdrh/safety.html
• http://www.eye-medi.com