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Investigator Name and Facility

Investigator Name and Facility. NORMAL VISION. NEARSIGHTEDNESS. FARSIGHTEDNESS. ASTIGMATISM. Can’t see distant things well. Can’t see near things well. Vision is blurred. LENS IN EYE IS LIKE A CAMERA LENS. LENS. LIGHT RAYS shine through lens onto film. FILM. LENS

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Investigator Name and Facility

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  1. Investigator Name and Facility

  2. NORMAL VISION NEARSIGHTEDNESS FARSIGHTEDNESS ASTIGMATISM Can’t see distant things well Can’t see near things well Vision is blurred

  3. LENS IN EYE IS LIKE A CAMERA LENS

  4. LENS LIGHT RAYS shine through lens onto film FILM LENS Focuses light rays to provide clear image ontoFILM LIGHT RAYS

  5. LIGHT RAYS shine through lens onto retina (back of the eye) RETINA LENS Focuses light rays to provide clear image ontoRETINA LENS LIGHT RAYS

  6. DAMAGED LENS As you age, your lenses get cloudy and don’t focus light rays as sharply on the retina. You developCATARACTS CATARACT THE RESULT – Vision isn’t clear may see glare or halos around bright lights LIGHT RAYS

  7. VISION CAN BE RESTORED By removing the lens (cataract surgery) and replacing it with an artificial one(intraocular lens or “IOL”)

  8. OPTIC Part of the lens that focuseslight on the retina HAPTICS Small filaments connected to the optic that hold the lens in place in the eye HAPTIC OPTIC HAPTIC

  9. WHY THIS IOL? It is designed to block most ultraviolet (uv) and some visible blue light It can be placed in the eye through a small incision WHY IS THIS STUDY REQUIRED? Any new IOL to be sold in the US must be tested in patients before FDA approval HOYA IOL is made with proprietary new acrylic material designed to block some visible blue light (This IOL is currently being marketed in Japan and Europe)

  10. WHO MONITORS THIS STUDY? Investigator Name (investigator) Promedica International (monitoring company) HOYA (study sponsor) Institutional Review Board (responsible for subject protection) FDA WHO IS A GOOD CANDIDATE? Age 21 or older Has a cataract that should be removed Otherwise healthy eyes No previous surgery in the eye with the cataract Willing and able to come for ALL postoperative visits About 400 patients will receive the HOYA IOL; they will be followed for 36 months afterwards

  11. WHAT ARE THE RISKS? Exactly the same as with any cataract surgery May be other risks that are currently unknown WHAT WILL I BE RESPONSIBLE FOR? Must return for 7 follow-up exams in the 3 years after surgery 1-2 days 1-2 weeks 1-2 months 4-6 months 11-13 months 21-26 months 33-38 months Must notify my office promptly of any eye-related problems you experience after surgery

  12. WHAT WILL YOU GET? Cataract surgery thru a small incision Vision correction that may offer benefits not generally available with other IOLs Your participation contributes to medical knowledge about cataract treatments. ADDITIONAL INFORMATION There is no extra charge for participation in this study You can drop out of the study at any time – it will not affect the quality of your care Records identifying your participation in the study will be kept confidential If important information regarding the HOYA IOL becomes available, you will be notified

  13. HOW DO I GET STARTED? Call our office to schedule a visit to assess eligibility Review and sign a special consent document for this study CONTACT INFO HERE

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