Effectiveness of Orthokeratology in Myopia Control
Phase: NA
Conditions: Myopia
Sponsor: Illinois College of Optometry

IRB/RRC application 
 
Revised May 2012 
 
 
 
CHECK LIST FOR INVESTIGATOR’S SUBMITTING AN 
APPLICATION FOR THE INSTITUTIONAL REVIEW 
BOARD AND/OR THE RESEARCH RESOURCE 
COMMITTEE REVIEW 
 
  Face page complete 
 
  Signatures  
 Principal investigator 
 Faculty mentor, if a Senior Research Project 
 Associate Dean 
 Assistant Dean for Research 
 Service Chief(s), if research involves the Illinois Eye Institute or its patients 
 Chief of Staff, if research involves the Illinois Eye Institute or its patients 
 Senior Director of Student Development , if research involves students at ICO 
 Assistant Dean of Didactic Education, if research takes place in the preclinic lab space 
 
 
 Abstract 
 
 Introduction/Literature Review 
 
 Summary of Methods 
   
Description of subjects/study population  
 
Procedures 
 
Measurements 
 
Method of analysis 
 
 Benefits 
 
 Risks 
 
 Alternative Forms of Treatment 
 
 Consent Forms: 
 
 Protocol 
 
 
1 original with signatures and 1 electronic submission to IRB chair 
 
 
 
 
 
For RRC only: 
 
Pilot Information 
 
Budget 
 
Justification 

IRB/RRC application 
 
Revised May 2012 
 
APPLICATION FOR REVIEW AND APPROVAL OF CLINICAL RESEARCH AND INVESTIGATION INVOLVING 
HUMAN SUBJECTS 
 
All investigators in studies involving human subjects must provide the following information to the 
Institutional Review Board.  Please submit an original and an electronic copy via email of this completed 
application.  The application must be signed by the Principal Investigator, the Associate Dean, the Director of 
Research, the Service Chief (if the research will take place in a service), the Chief of Staff (if the research is to 
be conducted in the Illinois Eye Institute (IEI) or use IEI patients, Dean of Student Affairs (if research involves 
students at ICO), and Chair of Clinical Education (if research takes place in the preclinic lab space).  All 
material relating to the grant application, funding, research protocol and budget must be submitted as well. In 
addition, any recruitment materials (e-mails, fliers, etc), presentations, surveys, or questionnaires need to be 
submitted along with the protocol. 
 
Please complete all applicable items.  Do not indicate refer to attachment.   
 
Principal/Student Investigator: 
Jennifer Harthan, Yi Pang 
 
  
 
Co-Investigator(s)/Faculty Mentor (required for Senior Research Project): Valerie Kattouf, Janice Jurkus, Angela To 
Department/ Service Where Research Will Take Place:  Cornea Center for Clinical Excellence  
Title of Protocol: Effectiveness of Orthokeratology in Myopia Control 
 
Type of application:  
x
  Faculty Development 
  Senior Research Project 
(Check ALL that apply) 
  Resident Research Project 
  Grant 
 
  Corporate Contract 
  Other _______________ 
 
 
Project Period Requested : Start Date: June 1, 2016 
 
 
Ending Date: 6/1/ 2017 
 
 
 
 
 
 
 
(Not to exceed one calendar year from date of IRB approval) 
 
List All Sites Where Subjects Will Be Examined: Illinois Eye Institute 
  
 
 
I certify that the protocol and method of obtaining informed consent as approved by the Institutional Review Board 
will be followed during the period covered by this research protocol.  Any changes to the research protocol will be 
submitted to the IRB chair for review and approval prior to implementation.  I accept responsibility for the ethical and 
scientific conduct of this research; and assure that all application regulations, by-law’s, policies and procedures of 
the Illinois College of Optometry and the Illinois Eye Institute relative to the protection of human subjects involved in 
this research will be followed.   
 
 
__________________________________ 
 
 
____________________________ 
Principal/Student Investigator  
 
 
 
Date 
 
 
 
__________________________________ 
 
 
____________________________ 
Faculty Mentor (required for Senior Research Project) 
Date
ILLINOIS COLLEGE OF OPTOMETRY 
ILLINOIS EYE INSTITUTE 
Institutional Review Board 

IRB/RRC application 
 
Revised May 2012 
I. 
Research Protocol Description:  
 
A. Category of research activity  
THE IRB HAS THE RIGHT TO CHANGE THE CATEGORY OF RESEARCH 
 
x
 
FULL REVIEW - RESEARCH PRESENTING RISK TO SUBJECTS.     
 
a. 
Collection of data from children.   Exception to this rule is if it involves a file review only. 
 
b. 
Instillation of anesthetic, dilating, or any other type of drugs into the eye(s). 
   
c. 
Any procedure that touches the surface of the eye.  Common examples of this include, but 
are not limited to gonioscopy, electroretinography, and contact lens placement. 
 
d. 
Collection of biological samples in an invasive manner, such as blood samples by 
venipuncture.  
 
 
 
 
EXPEDITED REVIEW - RESEARCH PRESENTING MINIMAL RISK TO SUBJECTS.  
 
a. 
Collection of biological samples, if non-invasive or if patient care indicates a need for 
removal or collection.   
 
b. 
Recording of data from human subjects 18 years or older using noninvasive procedures 
routinely employed in clinical practice  
 
c. 
Voice recording made for research purposes such as investigations of speech defects.   
 
 
d. 
Moderate exercise by healthy volunteers. 
 
e. 
Study of existing data, documents, records, pathological specimens or diagnostic 
specimens.   
 
f. 
Research on individual or group behavior or characteristics of individuals such as 
perception studies, cognition, game theory or test development where the investigator does 
not manipulate subjects and will not involve significant stress to subjects.   
 
g. 
Research conducted in established or commonly accepted educational settings, normal 
educational practices, e.g.  i) research on regular and special education strategies or ii)  
research on the effectiveness of or the comparison among instructional techniques, 
curricula or classroom management techniques.   
 
h. 
Research involving the use of educational tests (cognitive, diagnostic, aptitude, 
achievement), survey procedures, interview procedures or observation of public behavior 
unless:  i) information  obtained is recorded in such a manner that subjects can be 
identified, either directly or through identifiers linked to the subject, or ii) any disclosure of 
subject’s responses outside the research could reasonably place the subject at risk of 
criminal or civil liability or be damaging to the subjects financial standing, employability or 
reputation.   
 
 
B. 
Does this research involve the use of Investigational New Drugs(s)? 
x
  No  
  Yes  
If yes,   
 
Drug Name: 
 
 
Company: 
 
 
 
IND Number: 
 
Phase:  
 I 
 II 
 III 
 IV 
 
 
 
C. 
Does this research involve the use of an Investigational Medical Device? x
  No  
 
  Yes  

IRB/RRC application 
 
Revised May 2012 
If yes,   
 
Device Name:   
 
Company:   
 
IDE Number:   
 
D. 
Human subjects from the following population will be involved in this study (Check all that apply):   
 
 
x
  
Minors (under the age of 18 years)  
 
Pregnant Women 
 
 
Individuals with mental illness 
 
Prisoners 
 
 
Individuals with intellectual disability 
 
The Unborn 
 
 
E. 
Will a student conduct the research? 
 
 
 
 
x
  No  
 
  Yes  
If yes,   
What is student’s previous experience? 
 
 
What is the additional training provided by the faculty mentor, if needed? 
 
 
Will the student be supervised during invasive procedures? 
 
  No   
  Yes  
If no, please provide a detailed explanation as to why. 
 
 
 
II. 
Abstract - Brief (200 words or less) description of purpose, methods, and expectation.   
 
 
 
The high prevalence of myopia – especially in Asian countries – is well documented, as are the sight-
threatening complications of high or degenerative myopia.  Retinal detachment, glaucoma, vitreal 
degeneration and focal retinal changes may occur secondary to the progressive axial elongation of the eye 
with age.  Specialty rigid lenses have long been shown to lessen this progression in the pediatric population; 
orthokeratology (ortho-k) lenses are worn at night and change the corneal topography to correct low to 
moderate amounts of myopia. Most of the studies on orthokeratology were conducted on Asian children. To 
the best of our knowledge, no study has been done on African American (AA) children. Our project seeks to 
investigate the efficacy of ortho-k in slowing axial elongation and myopic progression in AA children 
compared to that in other races.   
 
III. 
Introduction/literature review: Please describe the research rationale, aim, and hypothesis with relevant 
background (citing published studies).   Also, provide a list of pertinent references. 
 
 
Orthokeratology (ortho-k), when used for partial or full correction of myopia, has been shown to slow myopic 
progression in children by 36-56% as compared to their spectacle or contact-lens wearing peers.1  This 
effect is achieved by limiting the axial elongation of the eye,1, 2,3, 4 which is of particular concern in high 
myopes (>6.00D) and children, where myopic progression has been shown to proceed at a faster rate than 
average.1  As early intervention is considered beneficial if not essential, Ortho-k as a treatment modality for 
diminishing myopic progression has, to our knowledge, been studied mostly in Asian children.   
 
 
 
The safety and efficacy of ortho-k as a means of decreasing myopic progression was well established by the 
Children’s Overnight Orthokeratology Investigation (COOKI), who evaluated refractive error, visual changes 
and ocular health over a period of 6 months in myopic children. 7 The Longitudinal Orthokeratology 
Research in Children (LORIC) study looked at axial elongation in children as old as 12 years, and found that 
ortho-k decreased axial elongation by approximately 50% compared to be-spectacled controls. 2   They also 
noted, however, high variability amongst the children that limits the clinician’s ability to predict the outcome 
of the intervention.2  The Corneal Reshaping and Yearly Observation of Myopia (CRAYON) study confirmed 
that patients fit with ortho-k lenses showed less change in axial length and vitreous chamber depth when 
compared to subjects wearing soft contact lenses. 3 Other more recent studies by Santodomingo-Rubido et 
al, 7 Kakita et al4 and Charm et al1 confirm this decrease in axial elongation using IOL Master 
measurements.   
 
 
 
The most commonly accepted theory on how orthokeratology decreases axial elongation relies on the 
peripheral defocus created on the retina by the corneal changes made by the rigid lens. 9   Hoogerheide et 

IRB/RRC application 
 
Revised May 2012 
al showed that those at greatest risk for myopic progression were those whose peripheral refraction was 
hypermetropic10 – that is, they had a hyperopic peripheral ‘defocus’.  A number of studies have since 
suggested that treatment approaches to myopia correction should address this peripheral refraction as a 
means of slowing further axial elongation.9 When looking at subjects treated with ortho k, we see that the 
lenses do in fact introduce a peripheral myopic defocus while leaving the central refraction more or less 
emmetropic. 9 With this study, we hope to expand potential application of orthokeratology to a novel 
population, AA children.  
 
References 
 
1. 
Charm, J, Cho P. High Myopia - Partial Reduction Ortho-k: A 2-Year Randomized Study. Optom Vis 
Sci. 90.6 (2013): 530-539.  
2. 
Cho P, Cheung SW, Edwards M. The Longitudinal Orthokeratology Research in Children (LORIC) 
in Hong King: A Pilot Study on Refractive Changes and Myopic Control. Curr Eye Res. 30. (2005): 
71-80.  
3. 
Walline JJ, Jones LA, Sinnott LT. Corneal Reshaping and Myopia Progression. Br J Ophthalmol  
1993. (2009): 1181-1185.  
4. 
Kakita T, Hiraoka T, Oshika T. Influence of Overnight Orthokeratology on Axial Elongation in 
Childhood Myopia. Invest Ophthalmol Vis Sci. 2011 Apr 6;52(5):2170-4.  
5. 
Loman J, Quinn GE, Kamoun L, Ying GS et al. Darkness and Near Work: Myopia and its 
Progression in Third-Year Law Students. Ophthalmology. 2002 May;109(5):1032-8.  
6. 
Kinge B, Midelfart A. Refractive Changes Among Norwegian University Students--A Three-Year 
Longitudinal Study. Acta Ophthalmol Scand. 1999 Jun;77(3):302-5. 
 7. 
Walline JJ, Rah MJ, Jones LA.  Children's Overnight Orthokeratology Investigation (COOKI) Pilot 
Study. Optom Vis Sci. 2004 Jun;81(6):407-13.   
8. 
Santodomingo-Rubido J, Villa-Collar C, Gilmartin B, Gutiérrez-Ortega R. Myopia Control with 
OrthokeratologyContact Lenses in Spain: Refractive and Biometric Changes. Invest Ophthalmol Vis 
Sci. 2012 Jul 31;53(8):5060-5. 
 9. 
Charman WN, Mountford J, Atchison DA, Markwell EL. Peripheral Refraction in Orthokeratology 
Patients. Optom Vis Sci. 2006 Sep;83(9):641-8.  
10. 
Hoogerheide J, Rempt F, Hoogenboom WP.Acquired Myopia in Young Pilots. Ophthalmologica. 
1971;163(4):209-15.   
 
 
 
IV. 
Summary of methods: describe study design by including:   
 
A. 
Description of subjects:   
1. 
number of participants 
2. 
selection process 
3. 
inclusion/exclusion criteria 
 
B. 
Procedures 
 
C. 
Measurements 
 
D. 
Method of analysis of data 
 
 
 
The study will be a randomized control study using a single-masked design to investigate axial elongation 
and myopic progression in children wearing ortho-k lenses (study group) versus single-vision spectacles or 
soft contact lenses (control group) for a period of 24 months.  A minimum of 40 and a maximum of 60 
subjects will be recruited from patients at Illinois Eye Institute.  Once eligibility has been determined by an 
unmasked observer, patients will be randomly assigned to either the orthokeratology group or the single-
vision contact lens /spectacle group.  
 
 
Patient recruitment: Both research alert and chart review in E.H.R. will be used to help us recruit patients. 
 
 
Eligible participants will be informed of the benefits and risks of the study both verbally and in writing.  Ethics 
approval will be obtained from the Institutional Review Board at the Illinois College of Optometry. Inclusion 
criteria include: the subjects, aged from 6 to 13 yeares, must have yearly myopia progression ≤>-1.00 D , 
with a myopic prescription between -1.00D and -6.00D in at least one eye with refractive astigmatism 
<1.50D.  Visual acuity must be at least logMAR 0.10 (Snellen 20/25) or better at baseline examination in 
both eyes through best corrected manifest refraction.  Ocular examination must not reveal any strabismus, 

IRB/RRC application 
 
Revised May 2012 
ocular pathology or contraindications for orthokeratology lens wear, and no ocular trauma history.  Subjects 
must be in good general health with no systemic conditions that might impact their ocular health or refractive 
error.  They must be willing to sleep a minimum of six hours per night. Finally, subjects must be willing and 
able to present to clinic for all necessary follow-up care.  Subjects will be excluded if their prescription falls 
outside the refractive guidelines,  have a history of any type of trauma or ocular surgery, have a history of 
prior experience with myopia control treatment, are amblyopic or if they are current gas permeable lens 
wearers. They will be discontinued from the study if they are non-compliant with the treatment protocol or do 
not achieve a desirable subjective result. 
 
 
Baseline examination will include measurement of logMAR acuity (monocular and binocular), subjective 
manifest refraction and auto-refraction (with cycloplegia) with measurement of peripheral refraction, anterior 
segment evaluation, corneal topography (tangential map recordings, including pupil measurement), IOL 
Master measurement of axial length and ultrasound pachymetry. Refractions will be performed with a 
maximum-plus endpoint which gives maximum vision.  Objective measurements (including IOL Master, 
autorefractor and pachymetry) will be taken in triplicate and averaged at both baseline examination and 6-
month examination.  Cycloplegic measurements will be taken at the baseline, 6-month evaluations, 12-
month evaluations, and 24-month evaluations.   Measurements will be taken approximately 30 minutes after 
instillation of drops, in this order; Proparacaine 0.5%, Tropicamide 1%, and Cyclopentolate 1%. 
 
 
 
After baseline examination, specialty orthokeratology (Euclid) lenses will be ordered for those assigned to 
the treatment arm based on topography, non-cycloplegic refraction, pupil size, and horizontal visible iris 
diameter.  Subjects will have a dispensing appointment as well as after-care appointments at 1-day (+/- 1 
day), 1-week (+/-3 days), 1-month (+/-1 week), 6-month (+/-15 days), 12-month (+/-15 days), 18-month (+/-
15 days), and 24-month (+/-15 days).  Lenses and solutions will be provided at no cost to the subject by 
examiners.   
 
 
The subjects wearing spectacles will have a baseline examination, and follow up appointment at 6-month, 
12-month, 18-month, and 24-month. New spectacle lenses will be provided at no cost to the subject if their 
current lenses differ from their spectacle prescription (as determined by the examiner) by more than 0.50D 
in either sphere or cylinder power.  Throughout the study, spectacles will also be updated at no cost for 
every 0.50D change in either the sphere or cylinder measurement.  If spectacles are lost or broken, the 
investigators will cover 50% of the cost of replacement. The same protocol applies for those subjects 
wearing soft contact lenses. 
 
 
 
The principal investigator, co-investigator and supervisor, who will act as unmasked examiners, will collect 
all examination data except axial length.  Masked observers (up to a maximum of 3) will be trained by the 
principal investigator in the use of the IOL Master and will perform all measurements with the instrument.  
Objective measurements will be repeated three times and averaged to minimize inter-operator differences. 
Refractions will be performed at each examination and will follow a specific protocol to generate a balanced, 
maximum-plus endpoint.  All subjects will be required to wear the prescribed treatment every day for the 6-
month period under investigation.   
 
Repeated measure ANOVA will be performed to determine if change of refractive error and axial 
length is different comparing subjects in the ortho-K group vs. ones in the control groups. 
 
 
V. 
Describe the potential scientific benefit(s) of the study. 
 
 
Those with myopia would most immediately benefit from this research. Subjects who were not treated with 
ortho-k at a young age would benefit from evidence that the lenses are effective in an older population.  
Another beneficiary would be the segment of the population at highest risk for degenerative changes: those 
who have high (>6.00 diopters (D)) myopic refractive errors or those whose axial length elongates at a 
faster rate than average. These subjects would be most poised to benefit from this research, as axial length 
has been directly linked to increased risk of ocular pathology. 
 
VI. 
Outline the risks to the subjects and precautions that will be taken to minimize them.  Note:  risks may 
extend beyond physical risk and may include psychological, social, and/or financial risk(s) 
 

IRB/RRC application 
 
Revised May 2012 
 
While orthokeratology is considered to be a safe and effective procedure by the American Academy of 
Ophthalmology, potential risks include: mild lens binding upon awakening, corneal staining, solution allergy, 
fluctuating vision, irritation, redness, and in rare cases, corneal infection.  To minimize risks, patients will be 
well educated on proper lens wear and care and will be provided with the appropriate solutions at no cost.  
Patients will also be given written instructions. Patients will also be seen for frequent follow-up care and will 
have the 24 hour emergency contact information for the Urgent Care Service at the Illinois Eye Institute.   
 
VII. 
Describe the methods to be used to insure confidentiality of data.   
 
In order to ensure confidentiality, each subject will be randomly assigned a unique study number.  
Therefore, all data will be tracked by number rather than by an IEI chart number, name, or initials.  Only the 
researchers will have access to that information.  All data throughout the study will be coded using this ID 
number.  The randomized numbers will be kept separate from the data collected.   
 
VIII. 
All research requires that the subject be aware of the fact that they are participating in a research project.  
This is accomplished using an Informed Consent Process that includes a verbal and written description of 
the project and other relevant information.  The Consent Form is used for adults (individuals over the age of 
18) and children or individuals who are not their own legal guardian (to obtain assent).  The form must be 
written at an eighth grade (or lower) level and fully explained to the research subject.  It must also be signed 
by the research subject, a legal guardian, if necessary, and a witness. Please refer to Handbook For 
Investigator for specific guidelines to be followed.   
A. 
Consent forms should be attached.    
B. 
Describe the process that will be used to obtain consent, including information on who will obtain 
the consent, and where and when will it be obtained.  
 
Investigators will consent the parents and children in either pediatric clinic or contact lens clinic. 
 
IX. 
Please provide additional information that will be beneficial to the IRB. 
 

IRB/RRC application 
 
Revised May 2012 
The following apply to proposals that are being submitted for review by the Research Resource Committee only: 
 
Pilot Study 
 
Certain studies are meant to obtain preliminary information in order to determine if a larger more involved study 
would be worthwhile.  Such studies are considered pilot studies.  Sometimes these studies require a minimum 
budget other times the budget may be quite extensive.  The research allocation committee may look at your request 
in a different manner if your request for funding involves a pilot study.  Many of the projects funded are considered to 
be pilot studies. 
 
 
X. 
Budget 
 
In writing research budgets for ICO funding the following factors should be considered. 
 
1. 
The total faculty research budget is limited.  The amount can vary with the academic year.  Funding for large 
projects (generally over $5000) is usually not a possibility.  The Research Resource Committee will do its 
best to support faculty requests on a first come first supported basis.  The fiscal year ends on June 30th.  
Requests for funds should be submitted as early as possible during the academic year.  Include all itemized 
costs for funding.  Approved funds not spent by July 1st  (end of the academic year) are deposited back to 
the general fund.  A new request will need to be submitted. 
 
2. 
Certain budget items will not be funded.  These include money allocated for salary, travel, long term support 
for experimental animals or services that could be provided by ICO support or secretarial staff.  Payment of 
human subjects for research projects will be considered on a case by case basis. 
 
 
Justification 
 
The Research Resource Committee may look at a research project on the basis of its interaction with other ongoing 
or upcoming faculty projects.  Please indicate whether a portion of your budget for items or equipment can be 
reused for other faculty projects.  This may include a project that may be a continuation of the first project or a new 
project by another faculty member.  It is not a requirement that faculty justify their request for funding on the basis of 
other future research projects.  The committee would request that justification be provided for any high priced items 
and any items listed in the miscellaneous categories. 
 
 
This study is supported by Wessley Foundation, Euclid, and Bausch & Lomb. Euclid will supply the ortho 
K lenses. Bausch & Lomb will supply the contact lens solution.

IRB/RRC application 
 
Revised May 2012 
INSTITUTIONAL ENDORSEMENTS 
 
 
Your endorsement is required to assure the Institutional Review Board (IRB) that you have reviewed this research 
protocol and approve it for submission, and that this protocol will be supported by your service(s) if approved by the 
IRB.  
 
 
 
 
_________________________________ 
 
_________________________________ 
Service Chief (if needed) 
 
 
 
Date 
 
 
 
_________________________________ 
 
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Chief of Staff (if needed) 
 
 
 
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_________________________________ 
 
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Assistant Dean for Research (required) 
 
 
Date 
 
 
 
 
_________________________________ 
 
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Associate Dean (required) 
 
 
 
Date 
 
 
 
 
 
_________________________________ 
 
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Sr. Director of Student Dev.  (if needed)  
 
Date 
 
 
 
 
_________________________________ 
 
_________________________________ 
Asst. Dean of Didactic Education (if needed)  
Date