The American Academy of Optometry Announces the

2016 Clinical Research Award

This document defines the purpose of the award, eligibility requirements, the
letter of intent requirement, the award application process, and the funding
process.

Purpose of Award:
To answer clinically meaningful questions that will have a significant
impact on vision and eye care.
To provide a mechanism for Academy Fellows to conduct clinical
research

Summary of the Award

Up to $100,000 award per project.
Project must be completed within two years.
Academy will fund direct costs only (no funding for indirect
expenses/Facilities &Administration Expenses (F&A)).

Eligibility Requirements
Each research group must name an individual Academic Partner
who has research experience and has published in refereed
journals in the area of investigation.
All listed investigators (PI and co-investigators) must be Academy
Fellows in good standing.
Ideally 60% of the investigator group will be in clinical practice
outside of an academic institution. If this is not possible because of
the particular study topic an explanation must be included.
The research project must address a relevant clinical question and
have the potential to positively impact eye care.
Investigator(s) must submit study results to the Academys Scientific
Program Committee for presentation at the Annual Meeting and to
Optometry and Vision Science or other peer-reviewed journals for
publication.

The Letter of Intent

Prospective applicants should submit a letter of intent (LOI) for the purpose
of defining the applicants eligibility. The LOI must stipulate that the

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principal investigator (PI) and all co-investigators are Academy Fellows in
good standing and specify all practice location/affiliations. Each application
must state the name of the Academic Partner to the study group.

In a given application cycle, an applicant (PI) can only submit one LOI and
upon eligibility approval, one proposal. Additional LOIs or proposals from
the same PI per funding cycle will not be considered.

The LOI will be reviewed by the Clinical Research Award review

committee, who will inform applicant PIs whether or not they should
proceed with the submission of a full proposal.

The LOI must be no more than 5 pages and should include the following:

1. Study Objectives and Research Question/Hypothesis: Describe the

objectives of the study and the research question / hypothesis posed.
2. Rationale for Proposed Research: Briefly describe what important
clinical problem the research project is addressing and how the
proposed study achieves the purpose of the American Academy of
Optometry Clinical Research Award.
3. Description of Methods: Provide an overview of the proposed study
design and methods.
4. Names and CVs of the Academic Partner, Principal Investigator and
Research Team: List key members of the research project team,
including consultants, with a description of each members role in the
project and their affiliations/appointments.

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 Application for American Academy of Optometry
Clinical Research Award
COMPLETE THIS FORM ONLY IF YOU HAVE RECEIVED AN
ACCEPTANCE OF YOUR LETTER OF INTENT FROM THE
AMERICAN ACADEMY OF OPTOMETRY.

This application must be written in the format described herein.

1. Members of the Research Group

a. Principal Investigator (PI): Name the one person responsible for the
scientific and technical direction of the project.

Degree(s): Indicate all research and professional degrees of the PI.

Position / Title: Provide any academic or professional titles of the PI.

Organizational Affiliation & Location: Indicate address, institute/practice

name and any affiliations.

Contact Information: Provide a daytime telephone number, email address

and if available, a fax number.

b. Co-investigators: Provide names, degrees, affiliations/location, and

email addresses of all co-investigators

Curriculum Vitae: Attach a current CV for the all named investigators.

c. Academic Partner: Name, institution, email address and short CV.

2. Project/Performance Sites

Indicate where the work described will be conducted. List all sites (names
and addresses of the locations) where the study will be performed, including
the locations of clinical labs or other ancillary facilities involved in carrying
out the research.

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3. Title of project

4. Study Aims (limit 1 page)

State concisely the broad objectives of the proposed research and

summarize the expected outcome(s), including the impact that the results
will have on the field and clinical practice.
List the specific aims/objectives of the research proposed e.g., to test a
hypothesis, create a novel design, solve a specific problem, challenge an
existing paradigm or clinical practice, address a critical barrier to
progress in the field, or develop new technology.

5. Background, Significance, and Literature Review (limit 3 pages)

Review the condition or disease under study (referencing epidemiologic

data, etiology, and symptoms), as applicable, and discuss the current
standard of care and/or available treatments.

Critically evaluate existing knowledge, and identify gaps that the study is
intended to fill. Discuss the potential significance of the study (e.g., how the
knowledge developed may impact future clinical practice, the cost of
delivering health care, etc.).

Discuss prior work that has been done in this area, including any pilot
studies that you have done. Provide any other information that may help to
establish the experience and competence of the study team to pursue the
proposed project.

6. Research Design / Methods (limit 8 pages)

Describe the overall strategy and methodology to be used to accomplish the

specific aims of the project. Include how the data will be collected, analyzed,
and interpreted.

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Design: Describe the type of study being proposed (e.g., observational, case-
control, cross-sectional, randomized clinical trial, etc.). Justify why you
chose this design.

Describe all arms of the study (experimental and control). Identify primary
and secondary outcomes/endpoints. It may be helpful to provide a schematic
diagram of the study design, procedures, and phases.

Describe measures you will take to minimize bias (e.g., randomization,

masking). If randomization will be used, describe the randomization
procedure. If there will be a control group with no randomization, describe
how it will be determined who is enrolled into the experimental and control
arms of the study. If matched controls will be used, describe matching
criteria (sex, age range, etc.). Describe if masking will be implemented and
if so, who will be masked?

Describe the target population and the criteria for selecting and enrolling
study subjects. How many subjects are expected to be enrolled into the
study? What are the inclusion and exclusion criteria? Define stop points and
criteria for early withdrawal of subjects from the study. Discuss when and
how subjects will be withdrawn as well as plans for data collection and
follow-up for withdrawn subjects.

Estimate study duration and time it will take to complete each portion of the
study, including follow-up, as applicable.

Methods and Procedures: Summarize the study methods and procedures,

including interventions, procedures, visits, and the sequence of all study
activities. If drugs will be administered, describe the dose, frequency, route,
and duration.

Describe how the research procedures differ from standard care. Describe
any new or experimental methods that will be used and their advantage over
accepted methods.

Discuss potential problems associated with the proposed study, including

any potential risks to subjects and personnel, and precautions to be
exercised.

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Describe data collection procedures, including methods to be used to record
and store data.

7. Statistical Methods and Analysis (limit 1 page)

Describe the statistical methods that were used to determine the appropriate
sample size and that will be used to address each study objective.

8. Human Subjects

Describe the composition of the proposed population (in terms of race,

ethnicity, sex, age, socio-economic factors, ocular/systemic diagnoses, etc.)
and the rationale for the participant inclusion/exclusion.

Describe how potential study subjects will be identified, recruited, and

enrolled. State who will be involved in recruiting, enrolling, and examining
participants.

9. References

Provide complete references using the Optometry and Vision Science

Guidelines for Authors for appropriate formatting of references.
(https://ovs.edmgr.com/)

10. IRB

Name the academic or central IRB(s) that will review/approve the study.

11. Budget

Include a detailed budget and justification. Indicate funds allocated to the

Academic Partner (no more than 10%) and Statistician. Include costs for any
of the following when applicable: equipment, supplies, consultant and
investigator costs (including statistical analysis), laboratory testing of
biological materials, participant travel, participant incentives,
recruitment/advertisement, IRB fees and publication costs.
No indirect (i.e. facilities and administration) costs will be provided; the
applicants institution or practice may not use the award for these costs.

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Unallowable expenses include computers, computer peripherals, travel,
office supplies, association dues, cell phones, tuition, and textbooks.

Per patient funding will be paid to each research site according to the
approved budget.

Investigators cannot receive payment for subject visits where the

investigator will charge the patient and/or his/her insurance. In other words,
if the investigator will bill the patient or insurance for a visit, then s/he
cannot also receive a research payment for time spent examining the subject.

Prospective studies are preferred above retrospective studies.

12. Samples of study protocols to consider in the proposal development

Applicants may refer to the following examples of study protocols.

Go to details view and protocol for each study
http://drcrnet.jaeb.org/Studies.aspx?RecID=142

13. Formatting Specifications for the Application

The entire grant application may be no more than 20 pages. Font and margin
specifications must be followed; if not, the application may not be reviewed.

Font
Use Arial, Helvetica, Palatino Linotype or Georgia typeface, black
font color, and a font size of 11 points or larger. A symbol font may be
used to insert Greek letters or special characters.
Type density, including characters and spaces, must be no more than
15 characters per inch.

Paper Size and Page Margins

Use standard paper size (8 " x 11")
Use at least one-half inch margins (top, bottom, left, and right) for all
pages.

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Page Formatting
Use standard, single-column format for the text; do not use a two-
column format.
The application must be single-sided and single-spaced.
Consecutively number pages in the bottom margin throughout the
application. Do not use suffixes (e.g., 5a, 5b).
Do not include un-numbered pages.

14. Submission of the Completed Application

The completed application should be sent via email to Helen Viksnins

(helenv@aaopt.org) at the Academy office.

15. Deadlines/Timelines

Call for submissions (February 1, 2016)

Letter of intent submission deadline (March 30, 2016)
Invitation to submit proposal (May 30, 2016)
Grant proposal submission deadline (June 30, 2016)
Review committee completes review of proposals (September 15, 2016)
AAO Board of Directors ratifies review committee recommendations
(September 30, 2016)
Notification of awards and funds dispersed (October, 2015)
Awardees announced at the annual meeting awards ceremony