A (Prospective/Pilot) Study Evaluating the Effect of Cataract Surgery on the Daily Activity Levels of Elderly Patients
Conditions: Cataract, Diabetes, Hypertension, Obesity, Vision Disability
Sponsor: University of Pikeville

A (prospective/pilot) study evaluating the effect of cataract surgery on the daily 
activity levels of elderly patients.
Kelley Sedlock, O.D.
Duane Corbett, Ph.D.
Ian McWherter, O.D., F.A.A.O. 
Lawerence Tenkman, M.D.
Donald Bennett, O.D., M.D.
Keith Slayden, O.D.
Bennett and Bloom Eye Centers
1935 Bluegrass Ave
Suite 200 
Louisville, KY 40215
724-244-4644
ianmcwherter@gmail.com
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Title:  A (prospective/pilot) study evaluating the effect of cataract surgery on the daily 
activity levels of elderly patients.
Purpose: To evaluate the effect of bilateral cataract surgery with intraocular lens 
implantation on the daily activity levels of elderly patients.
Objective: The primary endpoint is the comparison of baseline activity levels to post -
operative week two activity levels in patients undergoing bilateral cataract surgery using 
the ActiGraph GT9X wrist monitor.
Background: Cataract formation is a natural aging process that can be inﬂuenced by 
environmental factors such as exposure to ultra violet light and diet (1). Additionally, 
metabolic disorders, such as diabetes can lead to an earlier development of cataracts 
(2). 
As cataracts develop, a patient’s vision can be affected (3). Reduced vision can limit 
activities of daily living and may even reduce a patient’s mobility (4). When this occurs, 
cataract surgery should be considered to help restore a patient’s vision. 
With the obesity and diabetic epidemic, proper diet and exercise is a major health 
initiative to control these diseases (5). If a patient's mobility is reduced as a result of 
poor vision - their ability to achieve adequate daily physical activity may also be effected 
(6). It is thought that improvement in vision may increase their activity levels and help 
combat these health issues.
This study will investigate the activity level of patients before and after undergoing 
cataract surgery to determine how improved vision quality from removal of the natural 
lens inside the eye and replacement with an artiﬁcial intraocular lens effects their activity 
level.
Study population: Adult patients undergoing bilateral cataract surgery and adult patients 
who have cataracts but are not undergoing cataract. Consecutive patients based on the 
inclusion criteria will be selected for the study.
Study design: Prospective
Masking: None
Randomization: None
Method: Consecutive patients who meet the inclusion criteria will be asked to participate 
in the study. Patients scheduled for bilateral cataract surgery will be asked to wear a 
wrist accelerometer (Actigraph Inc, Pensacola, FL) 10 days prior to their cataract 
surgery in their ﬁrst eye to determine their baseline activity level (7). The device is the 
size of a wrist watch and will have minimal burden to patients. Each monitor will be ﬁtted 
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on the wrist and worn for 24 hours a day, but can be quickly removed for medical 
procedures, patient care, or hygiene needs. Data, such as steps per day, total 
movements per day, minutes being sedentary and minutes moving at various intensities 
(e.g. light, moderate and vigorous), will be collected and analyzed to determine a 
patients overall general physical activity level. Set standards and cut offs will be used to 
correlate wrist accelerometry to physical activity and this has been studied previously. 
The patient will then undergo bilateral cataract surgery, having each eye done a week or 
two apart and both eyes set for distance. Cataract surgery will be performed in its usual 
manner using the standard post-operative care. Patients will then be asked to wear the 
wrist accelerometer again for 10 days following their surgery to measure their post-
operative physical activity level. Wrist monitors can be mailed to and from patients using 
prepaid envelopes. The pre and post-operative data will be analyzed to determine 
cataract surgery's effect on pre and post-operative activity levels.
To control for placebo effects, a control group of patients who have visually signiﬁcant 
cataracts but are not interested in cataract surgery at this time will also be asked to 
participate in the study. They will wear their wrist monitor for 10 days to collect base line 
data and the wear the wrist monitor again 14 days later for another 10 days.
Sample size: 30 patients will be enrolled in the study
Length of study: 12 months
Inclusion Criteria:
• Patients undergoing bilateral cataract extraction by phacoemulisﬁcatin with intraocular 
lens implantation and a planned bilateral distance vision target or patients with 
bilateral cataracts who are not having cataract surgery
• Patients aged 60 years old or older
• Best corrected visual acuity worse than 20/20 in each eye (meaning 20/25 or worse)
• Non-comanged patients
Exclusion criteria:
• Greater than 0.76 D pre-operative corneal cylinder, if having cataract surgery without 
a planned astigmatism correction (I.e Limbal relaxing incision or Toric intraocular lens)
• Planned implantation of a multifocal intraocular lens
• Visual ﬁeld defect which may reduce mobility
• Wheel chair bound patients
• Reduced vision from an ocular disease other than cataracts
• Patients with signiﬁcant dementia who are not able to fully comprehend the informed 
consent
Examinations:
Cataract surgery group
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• Baseline/pre-operative exam
• Cataract surgery ﬁrst eye
• Post-operative exam one, 1-3 days after cataract surgery ﬁrst eye
• Cataract surgery second eye
• Post-operative exam two, 1-3 days after cataract surgery second eye
• Post-operative exam three, 14-21 days after cataract surgery second eye
Cataract non-surgery group
• Baseline/pre-operative exam
Baseline exam/Pre-Operative exam:
• Ocular history
• Medical history
• Family history
• Social history
• Blood pressure
• Vitals (Pulse, blood pressure)
• Anthropometrics (Height, weight, body mass index)
• Pupils
• Extraocular Muscles 
• Confrontation ﬁelds
• Best correct visual acuity
• Manifest refraction
• Keratometry
• Intraocular Pressure
• Slit lamp exam
• Dilated fundus exam
• Other various health-related questionnaires (e.g., CHAMPS activity questionnaire)
Post-Operative Exam One
• Visual acuity ﬁrst eye
• Intraocular Pressure ﬁrst eye
• Slit Lamp Exam ﬁrst eye
Post-Operative Exam Two
• Visual acuity both eyes
• Intraocular Pressure both eyes
• Slit Lamp Exam both eyes
Post-Operative Exam Three
• Best Corrected Visual Acuity both eyes
• Manifest refraction
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• Intraocular Pressure both eyes
• Slit Lamp Exam both eyes
• Dilated fundus exam both eyes
• Health-related questionnaires (follow-up)
Risk/Safety Information:
A. Potential risks: 
The risks of wearing the mobility monitor are similar to wearing a wristwatch.  If applied 
and adjusted properly, there is minimal risk of skin breakdown or sores.  
The risk of cataract surgery is not increased in this study and the routine cataract 
surgery procedure is not consider part of this study. With any surgical procedure there 
are risks and the standard risk of cataract surgery include infection, inﬂammation, loss 
of vision, increased intraocular pressure that may lead to glaucoma, bleeding, retinal 
detachment, damage to the cornea and corneal edema (swelling of the tissue in the 
front part of your eye), damage to the iris (the colored part of your eye), cystoid macular 
edema ( swelling of the tissue in the back of your eye), or death, although this would be 
an extremely rare complication. You may need additional surgery to replace or 
reposition the intraocular lens or to treat any other ocular complications.
B. Potential beneﬁts to be gained by the subject:
Potential increased physical activity and improvement in vision and activities of daily 
living would be a beneﬁt to patients undergoing cataract surgery. Patients in both 
groups may beneﬁt by knowing they are potentially contributing to the increasing body 
of scientiﬁc knowledge.
C. Potential beneﬁts or information which may accrue to science or society in general, 
as a result of this work.
Evidence to determine if cataract surgery increases physical activity may help patients 
increase their exercise and combat obesity, diabetes, and heart disease.
D. Potential risks to subjects are reasonable in relation to anticipated beneﬁts.
Cataract surgery is one of the most common surgeries performed in the United States 
and the risk of serious vision loss is low. Patients undergoing cataract surgery can 
expect to have an improvement in their vision. The risks from wearing a wrist watch size 
activity monitor are extremely low and pose a minimum burden to patients.
Monitoring/Reporting Adverse Events:
Adverse events will be monitored by the primary and sub-investigators at each study 
site. Adverse events will be documented and properly reported to the study IRB when 
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indicated. All investigators will have direct phone access to the lead investigator 24/7 for 
emergency situations. Data on adverse events will be reported and checked monthly by 
the primary investigator at each site as well as the lead investigator to ensure that there 
is no increased risk to the study subjects.
Study Oversight: This study will be prematurely terminated if the procedure or 
medications are found to have a risk proﬁle that outweighs their beneﬁt for the study. 
This determination will be made by the lead investigator/sponsor in conduction with the 
primary investigators and IRB. The study will provide direct access to the study data for 
the purposes of monitoring, auditing, IRB review, and regulatory inspection.
Data Management and Safety Monitoring:
A. Who will be responsible for the data and safety monitoring? 
 
The lead investigator and the primary investigator at the research site will be 
responsible for data safety monitoring. The investigators are not independent from the 
study. 
B. What will be monitored?
 
Only subjects who meet the study eligibility criteria will be enrolled in this study. 
Additionally, the informed consent process will be conducted appropriately and informed 
consent will be obtained prior to any study procedure being performed. Data will be 
collected and analyzed by the guidelines set forth by the study protocol and adverse 
events will be reviewed promptly and reported as required to the IRB. HIPPA will be 
complied with at all times throughout the study and all patients will be assigned unique 
identifying numbers. The number of study dropouts will also be closely monitored. 
C. What are the procedures for analysis and interpretation of data, the actions to be 
taken upon speciﬁc events or endpoints, the procedures for communication from the 
data monitor to the IRB and site, and other reporting mechanisms? 
 
The Primary and sub-investigator(s) at the testing site will be responsible for the 
collection and storage of all study data. Data will be stored in a password protected 
cloud storage site and organized into an excel spreadsheet. The identity of each patient 
will be protected using a unique identifying number. A second spreadsheet will match 
that unique number with that patient’s name, and will be stored separately under 
password protection. The lead and principal investigators will evaluate the current data 
collection monthly to make sure it is in order and the study performance is progressing 
without incident. After study completion, all collected data will be analyzed by 
appropriate statistical tools.
D. What is the frequency of monitoring? 
 
Study data will be grossly monitored on a monthly basis to ensure that the study is 
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performing smoothly and that all data is being collected in accordance with the set study 
protocol.
E. What information will be reported to the IRB? 
 
All necessary data will be reported to the IRB in a prompt manner including but not 
limited to the frequency and dates of data monitoring, a cumulative summary of adverse 
events, an assessment of new research that could impact the safety of the subjects, a 
summary of privacy and data conﬁdentiality breaches, and any changes to the 
procedures risk-beneﬁt ratio. 
Informed consent: The protocol, informed consent document, and relevant supporting 
information will be submitted to the IRB for review and will be approved before the study 
is initiated. In addition, any subject recruitment materials will be approved by the IRB 
prior to being used. This study will be conducted in accordance with the ethical 
principles that have their origin in the Declaration of Helsinki and that are consistent with 
Good Clinical Practice and applicable regulatory requirements. The study must be 
conducted in accordance with the regulations of the United States Food and Drug 
Administration (FDA) as described in 21 CFR 50 and 56 [add 312 for IND studies or 812 
for device studies], applicable laws and the IRB requirements. Any change to the 
protocol will be submitted to the IRB for review and approval before implementation. A 
protocol change intended to eliminate an apparent immediate hazard to subjects will be 
implemented immediately provided the FDA and the reviewing IRB are notiﬁed within 10 
working days.
 
It is the responsibility of the investigator to provide each subject with full and adequate 
verbal and written information using the IRB approved informed consent document, 
including the objective and procedures of the study and the possible risks involved 
before inclusion in the study. Informed consent must be obtained prior to performing any 
study-related procedures, including screening and changes in medications including any 
washout of medications. A copy of the signed informed consent must be given to the 
study subject.
1. When and where will consent take place?
Informed consent will take place at the eye care facility during normal business hours in 
either a private ofﬁce or exam room. If a patient meets the eligibility requirements as 
determined by the primary investigator or sub-investigator they will inform the patient of 
the study and the risks/beneﬁts/alternatives of the procedure in English. The subject will 
be given adequate time to weigh their options and the risk/beneﬁts/alternatives of the 
study. If after adequate time is given, and all questions are answered, the subject 
wishing to participate will sign the informed consent documentation and they will be 
enrolled in the study. All primary and sub-investigators for the study will be required to 
pass the National Institute of Health Protecting Human Research Participants 
certiﬁcation.
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2. How will the subject's privacy be protected during the consent process?
Each testing site will comply with HIPAA guidelines at all times. Informed consent will be 
performed during normal business hours at the eye care facility. The informed consent 
will be conducted in a private ofﬁce or exam room.
Subject Payment and Costs: Subjects will not be paid for participating in this study. 
Subjects taking part in this study may incur added costs to themselves or their 
insurance company. The subject or their insurance company will be responsible for the 
following costs: All standard of care procedures, exams, and testing including cataract 
surgery and implantation of an intraocular lens. Patients may choose an upgrade 
cataract surgery package if they wish to reduce their dependence on glasses following 
cataract surgery.
Conﬁdentiality: Efforts will be made to keep each subject's personal information 
conﬁdential. All electronic data will be password protected, all paper records will be kept 
in private locked rooms, and patients in the study will be identiﬁed by unique ID 
numbers. However, we cannot guarantee absolute conﬁdentiality. Personal information 
may be disclosed if required by law. Subject’s identity will be held in conﬁdence in 
reports in which the study may be published and databases in which results may be 
stored.
Organizations that may inspect and/or copy the research records for quality assurance 
and data analysis include groups such as the study investigator and his/her research 
associates, the study sponsor, and (as allowed by law) state or federal agencies, 
speciﬁcally the Ofﬁce for Human Research Protections (OHRP) and the Food and Drug 
Administration (FDA) [for FDA-regulated research and research involving positron-
emission scanning], the National Cancer Institute (NCI) [for research funded or 
supported by NCI], the National Institutes of Health (NIH) [for research funded or 
supported by NIH], etc., who may need to access your medical and/or research records.
Intended Use of Data: After all the data has been collected and analyzed a scientiﬁc 
paper addressing the effects of cataract surgery on activity levels in elderly patients, will 
be written and submitted to a distinguished peer reviewed journal for publication.
References:
1. West SK, Valmadrid CT. Epidemiology of risk factors for age-related cataract. Surv 
Ophthalmol. 1995 Jan-Feb;39(4):323-34.
2. Endres W, Shin YS. Cataract and metabolic disease. JInherit Metab Dis. 1990;13(4):
509-16.
3. Congdon N, O'Colmain B, Klaver CC, Klein R, Muñoz B, Friedman DS, Kempen J, 
Taylor HR, Mitchell P; Eye Diseases Prevalence Research Group. Causes and 
prevalence of visual impairment among adults in the United States. Arch Ophthalmol. 
2004 Apr;122(4):477-85.
4. Hassan SE, Lovie-Kitchin JE, Woods RL. Vision and mobility performance of subjects 
with age-related macular degeneration. Optom Vis Sci. 2002 Nov;79(11):697-707.
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5. Waxman A, Norum KR. Why a global strategy on diet, physical activity and health? The 
growing burden of non-communicable diseases. Public Health Nutr. 2004 May;7(3):
381-3.
6. Lamoureux EL, Hassell JB, Keeffe JE. The determinants of participation in activities of 
daily living in people with impaired vision. Am J Ophthalmol. 2004 Feb;137(2):265-70.
7. Sasaki JE, John D, Freedson PS. Validation and comparison of ActiGraph activity 
monitors. J Sci Med Sport. 2011 Sep;14(5):411-6. doi: 10.1016/j.jsams.2011.04.003. 
Epub 2011 May 25.
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