Research

**Research Opportunities**

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For adults...

• who are 30-85 years of age

• who have a diagnosis of Fuchs' Dystrophy or corneal swelling following cataract surgery

• who are in need of a corneal transplant

• who are willing to come for follow-up visits over a period of three years

Study Procedures

You will be given an informed consent form to read. This document will provide much greater detail about the study. CPTS staff will also discuss the study and answer any questions that you may have before you decide whether or not to enter the study. If you decide to be in the study, you will need to sigh the informed consent form.

Study participants will first be screened to determined if they are eligible and then randomly selected into one of two groups: Group A (corneas stored in the liquid up to 7 days), or Group B (corneas stored in the liquid from 8-14 days). Neither you nore your doctor will know which group you have been assigned.

Screening examinations, tests, and post-op care will be done according to your doctor's usual standard of care. You will need to come back for all follow-up visits that the study staff has scheduled for you. Follow-up visits will last for three years.

The Coordinating Center at Case Western Reserve University in Cleveland, Ohio will contact you at least once a year to see how you are doing.

F.A.Q.

How do I know that this is safe?

Your corneal surgeon has already determined that you require a corneal transplant called an endothelial keratoplasty. The surgery will be performed the same way whether or not you are in the study. The study has set standards for the donor cornea to assure that the quality of the donor cornea you receive will be at least as good as the donor cornea you could expect to receive if you were not taking part in the study. We have no reason to believe that there is any greater risk for problems with either preservation time group.

What if I change my mind?

Your participation in this study is voluntary. If you decide to take part in the study, you can withdraw from the study at any time by contacting your eye doctor and by letting him/her know that you do not want to participate anymore.

Will I be compensated?

To compensate for travel and parking expenses, you will be provided $25 per completed visit over the next 3 years.

Is the study free?

The surgery, all office visits, and all treatment needed after surgery that are considered standard of care will be either you or your insurance company's responsibility. Certain additional study specific tests will be paid by the study sponsor.

 For More Information Call Focal Point Vision at

(210)614-3600

We thank you for your interest

in the Cornea Preservation

Time Study.

If each of us does our part, small as it may be,

collectively we can make a difference!

For more information please visit the study website at:

www.cpts.jaeb.org

To Review the Consent for the study please click link below:

/documents/CPTS Consent.pdf

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Do you suffer from Keratoconus or Corneal Ectasia?

Dr. James Lehmann, M.D. & Dr. Kenneth Maverick, M.D. are conducting a clinical Research trial to study an investigational treatment to stop or slow the progression of keratoconus and corneal ectasia.

You may qualify if you:

- are 12 years of age or older

- were diagnosed with keratoconus or were diagnosed with corneal ectasia after you received refractive surgery (e.g. LASIK, PRK)

- are able to come in for at least 8 office visits over a 12 month period

Please call Focal Point Vision at (210)614-3600 and ask to speak to Ashley Grizzard for more information and to schedule an appointment.