Informed Consent Form Essay

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Informed Consent form for men and women who attend eye clinic , and who we are inviting to participate in research. The title of our research project is “Comparison of Antibiotic-only and Antibiotic-steroid Combination Treatment in Bacterial Keratitis Patients: Double-blinded Randomized Clinical Trial.”

Name of Principal Investigator : Silvia Fransisca
Name of Organization : Department of Ophthalmology, First Affiliated Hospital Nanjing Medical University

This Informed Consent Form has two parts:
• Information Sheet (to share information about the research with you)
• Certificate of Consent (for signatures if you agree to take part)

You will be given a copy of the full Informed Consent Form

PART I: Information Sheet
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Voluntary Participation

Your participation in this research is wholly voluntary. It is your choice whether to participate or not. Whether you choose to participate or not, all the services you receive at this clinic will continue and nothing will change. You may change your mind later and stop participating even if you agreed earlier.

Information on the Trial Drug [gatifloxacin (Zymar) and dexamethasone 0.1% (Maxidex)]

The drug we are testing in this research is called gatifloxacin (Zymar) and dexamethasone 0.1% (Maxidex). Maxidex is usually given or being combined after patiens use Zymar for 2-3 weeks. This second research is called a "phase 2" trial.
The drug Maxidex is used to treat certain eye conditions due to inflammation or injury, it works by relieving symptoms such as swelling, redness, and itching. Rarely, stinging/burning of the eyes for 1 to 2 minutes may occur when you apply this medication. We know of no other problem or risks.

Some participants in the research will not be given the drug which we are testing. Instead, they will be given only the drug Zymar, the drug which is most commonly used in this region with no combination with the drug Maxidex. There is no risk associated with that drug and no known problems.

Procedures and Protocol

A. Unfamiliar Procedures
Because we do not
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