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Investigator Name and Facility - PowerPoint PPT Presentation


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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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Presentation Transcript
slide2

NORMAL VISION

NEARSIGHTEDNESS

FARSIGHTEDNESS

ASTIGMATISM

Can’t see distant things well

Can’t see near things well

Vision is blurred

slide4

LENS

LIGHT RAYS

shine through lens onto film

FILM

LENS

Focuses light rays to provide clear image ontoFILM

LIGHT RAYS

slide5

LIGHT RAYS

shine through lens onto retina (back of the eye)

RETINA

LENS

Focuses light rays to provide

clear image ontoRETINA

LENS

LIGHT RAYS

slide6

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

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VISION CAN BE RESTORED

By removing the lens (cataract surgery)

and replacing it with an artificial one(intraocular lens or “IOL”)

slide8

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

slide9

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)

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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

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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

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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

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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