IN THE STUDY. While on the study, the risks are: • Loss of Confidentiality: Every precaution will be taken to remove identifying information from all data taken for this study, but absolute assurance of confidentiality cannot be given.
IN THE STUDY. This consent form contains important information to help you decide if you want to be in the study. If you have any questions that are not answered in this consent form, ask one of the study staff. Please answer YES or NO to the following questions:
IN THE STUDY. You may receive up to for being in the study. You will be paid per completed visit as follows: Visit Compensation (amount) Screening Visit 1 Visit 2 Visit 3 Follow-up Telephone Call Total compensation for study completion will be up to for completion of all study visits and the
IN THE STUDY. The overall experience of the xxx.xx app enables users to earn points through their actions in the app. Points will be collected on an ongoing basis by the participant within the app. Cumulative points for this study will be 25,000 points (collected after the participant completes all study required procedures, including the final survey). Participants in this study who complete all the actions can convert these total 25,000 points to a one-time only Xxxxxx.xxx gift card of up to $250.00 in value through the link provided after the final survey. You will be offered a phone stand approximately $10 in value, if you need it. If you are invited to do the usability interview and complete the interview successfully, you will receive a one-time link for a total of $50, redeemable as a one-time Xxxxxx.xxx gift card. The principal investigator is an employee of xxx.xx on whose app this study is being conducted and is being paid by the sponsor to conduct this research study.
IN THE STUDY. You might feel tired from the eye exams or study procedures. Also, the eye exams and measurements may pose risks because some devices come very close to or touch your eyes. There is a small chance that the instrument used could scratch the surface of your eye. If that occurs, it is usually minor. Also, you may experience blurred vision or discomfort from the numbing drop that the study doctor gives you. These could last up to 24 hours after the exam. Also, there is a risk of allergic reaction (itching, redness, burning, or mucous discharge) to the ingredients in the anesthetic (numbing) eye drop used in these evaluations. If experienced, this could last up to 12 hours. Because your eyes are numb, it’s important that you do not rub your eyes for at least 20 minutes after the exam. The orange-yellow (Fluorescein) dye that will be put in your eyes to evaluate the intraocular pressure (pressure inside your eye) may make your skin and bodily secretions and excretions, such as your tears or mucous, change color, or they may cause some irritation to your eyes. This effect is usually temporary and disappears within a day. Rarely, people can have an allergic reaction to fluorescein dye. This would usually involve itching, swelling, or redness. If you develop such a reaction, you will receive treatment. As with any allergy, more serious or life threatening reactions are possible. No adverse reactions (bad side effects) have been reported for the Canon HS100 OCT or Optovue RTVue XR devices. Because the Canon HS100 OCT device is investigational (not yet FDA-approved), all of its side effects may not be known. There may be rare and unknown side effects. You must tell the study doctor and staff if you experience any side effects. If you are not honest about your side effects, it may not be safe for you to be in the study.
IN THE STUDY. Part 1 (Cohorts 1-6) Payment If in Part 1, you may receive up to $3300.00 for being in the study. You will be paid per completed visit as follows: You will receive two separate payments within 10 business days from Day 14 and Day 30. Visit Payment (amount) Screening $0.00 Day -1 $200.00 Day 1 $250.00 Day 2 $250.00 Day 3 $250.00 Day 4 $250.00 Day 5 $250.00 Day 6 $250.00 Day 7 $250.00 Day 14 $150.00 Day 21 $25.00 Day 30 $200.00 Bonus $975.00 *Total Payment* $3,300.00 To ensure that each dosing group reaches the maximum number of subjects, extra subjects will be recruited. All participants will be asked to complete research study procedures up to the time of dosing. In the event that a study subject is unable to dose, another qualified subject will take that subject’s place on the study. If you complete all the requirements, but are not dosed, you will receive a pro-rated stipend check based on information below. If you not selected to be in the study, you will be paid $200.00 if you are released on day -1 and $400.00 if released on day 1. As an alternate, you may be asked to participate in the next dosing group, which may require you to repeat Day -1 and Day 1 procedures. Part 2 (Cohorts 7, 8, 9, and 10) Payment If in Part 2, you may receive up to $6,400.00 for being in the study. You will be paid per completed visit as follows: You will receive two separate payments within 10 business days from Day 21 and Day 45. Visit Payment (amount) Screening $0.00 Day -1 $200.00 Day 1 $250.00 Day 2 $250.00 Day 3 $250.00 Day 4 $250.00 Day 5 $250.00 Day 6 $250.00 Day 7 $250.00 Day 8 $250.00 Day 9 $250.00 Day 10 $250.00 Day 11 $250.00 Day 12 $250.00 Day 13 $250.00 Day 14 $250.00 Day 15 $250.00 Day 16 $250.00 Day 17 $250.00 Day 18 $250.00 Day 19 $250.00 Day 20 $250.00 Day 21 $250.00 Day 30 $175.00 Day 45 $175.00 Bonus $600.00 *Total Payment* $6,400.00 To ensure that each dosing group reaches the maximum number of subjects, extra subjects will be recruited. All participants will be asked to complete research study procedures up to the time of dosing. In the event that a study subject is unable to dose, another qualified subject will take that subject’s place on the study. If you complete all the requirements, but are not dosed, you will receive a pro-rated stipend check based on information below. If you are not selected to be in the study, you will be paid $200.00 if you are released on day -1 and $400.00 if released on day 1. As an alternate, you may be asked to participat...
