PLEASE NOTE: All participants must live in a reasonable commuting distance to Indiana University in Bloomington, IN and/or be willing to cover all their own travel costs to the study location to participate. If you do not meet this criterion, please do not complete this form.
INDIANA UNIVERSITY STUDY INFORMATION SHEET FOR
Clinical Optics Research Lab (CORL) Study Participant Registry
IRB Study #1310511820
You are invited to participate in a research participant registry that links potential participants with researchers performing clinical studies. By providing your information, you are stating that you are interested in being contacted about studies for which you may qualify.
This registry is being conducted by Pete Kollbaum at the Clinical Optics Research Lab in the Borish Center for Ophthalmic Research at the IU School of Optometry. If you have any questions about this registry, please feel free to contact the Clinical Optics Research Lab at (812)855-5500 or CORL@indiana.edu.
STUDY PURPOSE
The purpose of this registry is to assist the Clinical Optics Research Lab in contacting individuals who are interested in any new or ongoing studies. Your information will be securely stored in the registry for an indefinite period of time or until you request it to be removed.
NUMBER OF PEOPLE TAKING PART IN THE STUDY:
If you agree to participate, you will be one of up to 500 individuals per year registering to take part in research studies at IU School of Optometry
PROCEDURES FOR THE STUDY:
If you agree to be in the registry, we will collect the following information about you and/or your child/dependent:
• Full name (and in case of a dependent, also contact person's full name)
• Contact information (e.g. phone, address, email)
• Date of birth
• Gender
• Glasses and/or contact lens prescription and wear information
• History of eye surgery and disease
Your information will help us match you with new or ongoing studies. If your information matches the needs of a current study, you may be contacted by the research team.
RISKS OF TAKING PART IN THE STUDY:
There is minimal risk for participating in this registry. The only risk is a potential loss of confidentiality, however, every effort will be given to maintain privacy and confidentiality of your information at all times.
BENEFITS OF TAKING PART IN THE STUDY:
The benefit of participating in this registry is the opportunity to be contacted by researchers for the latest studies being conducted in the Clinical Optics Research Lab.
ALTERNATIVES TO TAKING PART IN THE STUDY:
Instead of being in the registry, you may choose not to. If you are contacted about taking part in a specific clinical study and do not wish to take part, you can tell the researcher you are not interested.
CONFIDENTIALITY
Efforts will be made to keep your personal information confidential. We cannot guarantee absolute confidentiality. Your personal information may be disclosed if required by law. Your identity will be held in confidence.
Organizations that may inspect and/or copy your research records for quality assurance and data analysis include groups such as the study investigator and his/her research associates, the Indiana University Institutional Review Board or its designees, and (as allowed by law) state or federal agencies, specifically the Office for Human Research Protections (OHRP), who may need to access your research records.
FUTURE USE OF INFORMATION
Information collected from you for this study may be used for future research studies or shared with other researchers for future research. If this happens, information which could identify you will be removed before any information is shared. Since identifying information will be removed, we will not ask for your additional consent.
COSTS
There is no cost to you to participate in this registry.
PAYMENT
You will not receive payment for participating in this registry, but often some form of reimbursement will be provided by future studies in which you may be invited to participate.
CONTACTS FOR QUESTIONS OR PROBLEMS
For questions about this registry, please contact Pete Kollbaum or the Clinical Optics Research Lab at 812-855-5500. If you cannot reach him during regular business hours (i.e. 8:00AM-5:00PM), please follow the prompts provided on the phone message, or call the IU Human Subjects Office at (812) 856-4242 or (800) 696-2949.
For questions about your rights as a research participant or to discuss problems, complaints or concerns about a research study, or to obtain information, or offer input, contact the IU Human Subjects Office at (812) 856-4242 or (800) 696-2949.
VOLUNTARY NATURE OF STUDY
Taking part in this registry is completely voluntary. You may stop completing the registry at any time by closing your browser. If you are contacted about taking part in a specific research study and do not wish to take part, you can tell the researcher you are not interested. You may choose not to take part or may leave any study at any time. Not taking part in this registry or leaving the registry will not result in any penalty or loss of benefits to which you are entitled, and will not affect your current or future relations with IU School of Optometry, the Clinical Optics Research Lab or Pete Kollbaum.
By contacting the CORL at any time you may add, modify, or remove information from your registry or the registry of your dependents.
Web: www.opt.indiana.edu/corl/
Phone: 812-855-5500
Email: CORL@indiana.edu
AGREEMENT
By completing and submitting this registration form, you are providing your agreement to allow authorized personnel of CORL to retain this information without direct contact with you, so they may contact you about considering participation in an upcoming study. You can refuse to take part in any study and drop out of this registry for any reason.
A copy of the information sheet can be printed from the page, and the individual may return at any time and print the information sheet.
By checking below, you agree that CORL can use your information as described above. You also agree that CORL may access, keep or share profile information if required to do so by law.
In addition, in order for a person to "register someone else" they must also click a check box that states:
INDIANA UNIVERSITY
AUTHORIZATION FOR THE RELEASE OF HEALTH INFORMATION FOR RESEARCH
(NO ACCESS TO MEDICAL RECORDS)
Introduction: You have the right to decide who may review or use your Protected Health Information ("PHI"). The type of information that may be used is described below. When you consider taking part in a research study, you must give permission for your PHI to be used and disclosed by the research team for the specific purpose of this research study.
This authorization relates to the following study:
Title: Clinical Optics Research Lab (CORL) Study Participant Registry
IRB Protocol Number: 131051182
Principal Investigator: Pete Kollbaum, OD, PHD
Sponsor: Unsponsored
What information will be used for research purposes? The PHI used for this research study will include information that you provide to the research team and any data and reports created by the research team that may include this information. Your medical records will not be requested or otherwise accessed.
Who can access your PHI for the study? The Principal Investigator and members of his/her research team may share my PHI (or the PHI of the individual(s) whom I have the authority to represent), with the following persons or groups for the research study:
• The Institutional Review Boards (IRB) that review the study
• Indiana University:
• U.S. or foreign governments or agencies as required by law
Expiration date of the authorization: This authorization is valid until the research ends and required monitoring of the study has been completed.
Efforts will be made to ensure that your PHI will not be shared with other people outside of the research study. However, your PHI may be disclosed to others as required by law and/or to individuals or organizations that oversee the conduct of research studies, and these individuals or organizations may not be held to the same legal privacy standards as are doctors and hospitals. Thus, the research team cannot guarantee absolute confidentiality and privacy.
I have the right:
1. To refuse to sign this form. Not signing the form will not affect my regular health care, including treatment, payment, or enrollment in a health plan or eligibility for health care benefits. However, not signing the form will prevent me from participating in the research study above.
2. To review and obtain a copy of my personal health information collected during the study. However, it may be important to the success and integrity of the study that persons who participate in the study not be given access until the study is complete. The Principal Investigator has discretion to refuse to grant access to this information if it will affect the integrity of the study data during the course of the study. Therefore, my request for information may be delayed until the study is complete.
3. To cancel this release of information/authorization at any time. If I choose to cancel this release of information/authorization, I must notify the Principal Investigator for this study in writing to Pete Kollbaum at 800 E Atwater Avenue, Bloomington, IN 47405. However, even if I cancel this release of information/authorization, the research team, research sponsor(s), and/or the research organizations may still use information about me that was collected as part of the research project between the date I signed the current form and the date I cancel the authorization. This is to protect the quality of the research results. I understand that canceling this authorization may end my participation in this study.
4. To receive a copy of this form.
Title: Clinical Optics Research Lab (CORL) Study Participant Registry
IRB Protocol Number: 131051182
Principal Investigator: Pete Kollbaum, OD, PHD
I have had the opportunity to review and ask questions regarding this release of information/authorization form. By clicking "yes, I agree" release of information/authorization, I am confirming that it reflects my wishes.
* must provide value
Yes
No
Your first name
* must provide value
Your middle name or initial
* must provide value
Your last name
* must provide value
How are you related to the person you are registering?
* must provide value
Parent
Caregiver
Legal Guardian
Other
In what other way are you related to the person you are registering?
Please provide your contact information for at least one of the following options:
* must provide value
Your mailing address (street number; street name; apt/condo #; city; state; zipcode)
Your email address (XXXXX@yyyyy.zzz)
Your phone number (XXX-XXX-XXXX)
Registrant's first name
* must provide value
Registrant's middle name or initial
Registrant's last name
* must provide value
Registrant's date of birth
* must provide value
Today M-D-Y
Registrant's sex
* must provide value
Male
Female
Choose not to answer
Is the registrant an IU student?
Yes
No
Is the registrant an IU School of Optometry Student?
Yes
No
Anticipated graduation year
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
When was the registrant's last eye exam at an eye doctor?
<1 year ago
1-2 years ago
3-5 years ago
5-10 years ago
Never had an eye exam at an eye doctor
Unsure
Is the registrant a patient at the IU Atwater Eye Care Center?
Yes
No
May we access the registrant's eye care chart in order to verify the information you provide?
Yes
No
Has the registrant's eye doctor ever used any of these terms to describe their eyes/vision? (Check all that apply)
Does the registrant wear glasses?
Yes
No
Approximately how long has the registrant worn glasses?
< 1 year 1-5 years 5-15 years 15-30 years > 30 years Unsure
What does the registrant wear glasses for?
To see far away (driving, presentations, movies)
For reading or computer tasks only
Both far away (driving) and near (reading) tasks
Cosmetic reasons
Other
What other reason does the registrant wear glasses for?
I know or have record of the registrant's glasses prescription.
Yes
No
Using this example as a guide, over the next several questions please indicate the registrant's glasses prescription.
Note that you may NOT have a number in some of the indicated boxes. Please leave those questions blank.
Please include ALL + or - signs as they appear in your prescription.
What is your number "A"?
(Right Eye Sphere)
Please include any + or - signs as they appear in your prescription.
What is your number "B"?
(Right Eye Cylinder)
Please include any + or - signs as they appear in your prescription.
What is your number "C"?
(Right Eye Axis)
What is your number "D"?
(Right Eye Add)
Please include any + or - signs as they appear in your prescription.
What is your number "E"?
(Left Eye Sphere)
Please include any + or - signs as they appear in your prescription.
What is your number "F"?
(Left Eye Cylinder)
Please include any + or - signs as they appear in your prescription.
What is your number "G"?
(Left Eye Axis)
What is your number "H"?
(Left Eye Add)
Please include any + or - signs as they appear in your prescription.
Please check all that apply to describe the registrant's vision without their glasses. "WITHOUT wearing my glasses, I can..."
When looking far away (e.g. 20 feet), is your vision WITH your glasses about the same between your two eyes?
Yes
No
Which eye sees better when looking far away?
Right eye
Left eye
When looking up close (e.g. 10 inches), is your vision WITH your glasses about the same between your two eyes?
Yes
No
Which eye sees better when looking up close?
Right eye
Left eye
Does the registrant currently wear contact lenses?
Yes
No
What type of contact lenses? (If more than one, select the type worn most often.)
Soft contact lenses
Hard contact lenses (rigid, gas permeable)
Unsure
I know or have record of the registrant's contact lens prescription.
Yes
No
What does the registrant wear contact lenses for?
To see far away only (driving, presentations, movies)
For reading or computer tasks
Both far away (driving) and near (reading) tasks
Only for times where I cannot wear my glasses (e.g. sports)
Other
For what other reason does the registrant wear contact lenses?
How long has the registrant worn contact lenses?
< 6 months
1-3 years
4-8 years
> 8 years
Unsure
Does the registrant wear the same brand of contact lenses in each eye or different brands in each eye?
Same brand in each eye
Different brand in each eye
Regularly wear several different contact lens brands
What manufacturer(s) of contact lenses does the registrant wear?
If you are unsure, please click on the link below to open a new window with pictures to help you identify your contact lens manufacturer and brand.
What other manufacturer and brand of contact lenses does the registran wear?
What contact lens brand does the registrant wear?
Air Optix Aqua Air Optix Night & Day Aqua Air Optix for Astigmatism Air Optix Aqua Multifocal Focus Dailies Focus Dailies Aqua Comfort Plus Focus Dailies Toric Focus Dailies Progressives Focus Softcolors Monthly Fresh Look Fresh Look Toric Fresh Look Colors Fresh Look Color Blends Fresh Look Color Blends Toric Fresh Look Dimensions Fresh Look One Day Colors O2 Optix Ciba Dailies Total 1
What contact lens brand does the registrant wear?
Biotrue One Day PureVision PureVision Toric PureVision 2 PureVision 2 for Astigmatism PureVision Multifocal Soflens Daily Disposable Soflens Daily Disposable for Astigmatism Soflens 38 Soflens Toric Soflens Multifocal Optima 38 Optima Toric
What contact lens brand does the registrant wear?
Avaira Avaira Toric Biofinity Biofinity Toric Biofinity Multifocal Biomedics 38 Biomedics 55 Biomedics Toric Biomedics XC Clearsight 1 Day Clearsight 1 Day Toric Expressions Frequency 55 Frequency 55 Toric Frequency 55 Multifocal Hydrasoft Standard Hydrasoft Toric Preference Preference Toric Proclear Proclear Toric Proclear Multifocal Proclear Multifocal Toric Proclear 1 Day Proclear 1 Day Multifocal Vertex Vertex Toric
What contact lens brand does the registrant wear?
Acuvue Acuvue Oasys Acuvue Oasys for Astigmatism Acuvue Oasys for Presbyopia Acuvue Bifocal Acuvue TruEye 1 Day Acuvue 1 Day Acuvue 1 Day Moist Acuvue 1 Day Moist for Astigmatism Acuvue 2 Acuvue 2 Colours Acuvue Advance Acuvue Advance Plus Acuvue Advance for Astigmatism
Using this example as a guide, over the next several questions please indicate the registrant's contact lens prescription.
Note that you may NOT have a number in some of the indicated boxes. Please leave those questions blank.
Please include ALL + or - signs as they appear in your prescription.
What is your number "A"?
(Right Eye Sphere)
Please include any + or - signs as they appear in your prescription.
What is your number "B"?
(Right Eye Cylinder)
Please include any + or - signs as they appear in your prescription.
What is your number "C"?
(Right Eye Axis)
What is your number "D"?
(Right Eye Add/Other)
Please include any + or - signs as they appear in your prescription.
What is your number "E"?
(Right Eye Base Curve)
What is your number "F"?
(Right Eye Diameter)
What is your number "G"?
(Left Eye Sphere)
Please include any + or - signs as they appear in your prescription.
What is your number "H"?
(Left Eye Cylinder)
Please include any + or - signs as they appear in your prescription.
What is your number "I"?
(Left Eye Axis)
What is your number "J"?
(Left Eye Add/Other)
Please include any + or - signs as they appear in your prescription.
What is your number "K"?
(Left Eye Base Curve)
What is your number "L"?
(Left Eye Diameter)
On average, how often does the registrant change pairs of contact lenses?
Every day
1 week
2 weeks
1 month
2 months
3+ months
On average, how often does the registrant sleep in their contact lenses?
Never
Only for naps
Only if I forget to remove them (e.g. 1 time/week or month)
Occasionally (e.g. 2-3 nights per week)
Frequently (e.g. 5-7 nights per week)
30 days at a time
On average, how often does the registrant wear their contact lenses?
Every day
Several days per week
Only occasionally
On days when the registrant wears contact lenses, how many hours, on average, do they wear them?
1-4 hours
5-8 hours
8-12 hours
> 12 hours
24+ hours
What type of contact lens solution does the registrant use?
If you are not sure, please click the link below to open a new window with pictures to help you identify your solution.
AoSept Aquify 5 Minute Multipurpose Biotrue Multipurpose Clear Care Complete Moisture Plus MiraFlow Opti-Free Pure Moist Opti-Free SupraClens Oxycept Renu Fresh Renu Sensitive RevitaLens OcuTec Disinfecting Solution Ultrazyme Universal Unizyme Enzymatic Cleanser Bausch + Lomb Sensitive Eyes Saline Bausch + Lomb Sensitive Eyes Saline Plus Softwear Saline Unisol 4 Saline "Whatever is on sale" Store Brand Water Unknown
What type of contact lens solution does the registrant use?
If you are not sure, please click the link below to open a new window with pictures to help you identify your solution.
Boston Advance Cleaning Solution - Comfort Formula Boston Advance Conditioning Solution - Comfort Formula Boston Conditioning Solution Boston One-step liquid enzymatic cleanser Boston Original Cleaning Solution Boston Simplus Multi-Action Solution Clear Care MiraFlow Opti-Free GP Solution Opti-Free SupraClens Ultrazyme Universal Bausch + Lomb Sensitive Eyes Saline Bausch + Lomb Sensitive Eyes Saline Plus Softwear Saline Unisol 4 Saline "Whatever is on sale" Store Brand Water Unknown
Does the registrant wear glasses over their contact lenses?
Yes
No
Why does the registrant wear glasses over their contact lenses?
To see far away only (driving, presentations, movies)
For reading or computer tasks
Both far away (driving) and near (reading) tasks
Please check all that apply to describe the registrant's vision without contact lenses. "WITHOUT wearing my contacts, I can..."
When looking far away (e.g. 20 feet), is your vision WITH your contact lenses about the same between your two eyes?
Yes
No
Which eye sees better when looking far away?
Right eye
Left eye
When looking up close (e.g. 10 inches), is the registrant's vision WITH contact lenses about the same between the two eyes?
Yes
No
Which eye sees better when looking up close?
Right eye
Left eye
Has the registrant ever been told they have or may have any of the following eye conditions? (Check all that apply)
What other eye condition(s) has the registrant been told they have or may have?
Has the registrant ever had any sort of eye surgery? (Check all that apply)