Investigator Name and Facility
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Transcript of Investigator Name and Facility
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Investigator Name and Facility
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NORMAL VISION NEARSIGHTEDNESS FARSIGHTEDNESS ASTIGMATISMCan’t see distant things well Can’t see near things well Vision is blurred
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LENS IN EYE IS LIKE A CAMERA LENS
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LENSFocuses light rays to provide clear image onto FILM
LIGHT RAYS shine through lens onto film
FILM
LIGHT RAYS
LENS
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LIGHT RAYS
LIGHT RAYS shine through lens onto retina (back of the eye)
LENS
RETINA
LENSFocuses light rays to provideclear image onto RETINA
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As you age, your lenses
get cloudy and don’t focus
light rays as sharply on
the retina.
You develop CATARACTS
DAMAGED LENS
CATARACT
THE RESULT –
Vision isn’t clear
may see glare or halos
around bright lightsLIGHT RAYS
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VISION CAN BE RESTOREDBy removing the lens (cataract surgery)
and replacing it with an artificial one
(intraocular lens or “IOL”)
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OPTICPart of the lens that focuses
light on the retina
HAPTICSSmall filaments
connected to the
optic that hold
the lens in place
in the eye
OPTICHAPTIC HAPTIC
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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