The Investigation of Capsular Tension Rings in Intraocular Lens Rotation
Phase: NA
Conditions: Cataract, Ophthalmoplegia, Ophthalmologic Complication
Sponsor: Rachel Lieberman

Document Date: 2/15/2022
NCT: NCT04436198
The Investigation of Capsular Tension Rings in Intraocular Lens Rotation

EIRB Protocol Template (Version 1.10)
1.0
General Information
*Please enter the full title of your study:
The Investigation of Capsular Tension Rings in Intraocular Lens Rotation
*Please enter the Protocol Number you would like to use to reference the protocol:
FWH20200112H
* This field allows you to enter an abbreviated version of the Protocol Title to quickly identify
this protocol.
Is this a multi-site study (i.e. Each site has their own Principal Investigator)?
No
Does this protocol involve the use of animals?
Yes
No
2.0
Add Site(s)
2.1 List sites associated with this study:
Primary 
Dept?
Department Name
USAF - 99 MDG/MOFMC
3.0
Assign project personnel access to the project
3.1 *Please add a Principal Investigator for the study:
Lieberman, Rachel Anne, MD
Select if applicable
Student
Site Chair
Resident
Fellow
3.2 If applicable, please select the Research Staff personnel:
A) Additional Investigators
B) Research Support Staff
N

BIRD, CHRISTOPHER W 
 Research Coordinator
Bogdanovich, Tracy Lee 
 Research Coordinator
Clark, Jill Marie, MBA/HCM 
 Research Coordinator
Crawford, Amanda J 
 Research Coordinator
Estrada, Jonica 
 Research Coordinator
Huffman, Sandra G 
 Research Coordinator
Moss, Jennie B 
 Research Coordinator
Shaffer, Daniel WILLIAM 
 Research Coordinator
3.3 *Please add a Protocol Contact:
 
Clark, Jill Marie, MBA/HCM 
Huffman, Sandra G 
Lieberman, Rachel Anne, MD 
The Protocol Contact(s) will receive all important system notifications along with the Principal 
Investigator. (i.e. The protocol contact(s) are typically either the Protocol Coordinator or the 
Principal Investigator themselves).
3.4 If applicable, please select the Designated Site Approval(s):
 
Add the name of the individual authorized to approve and sign off on this protocol from your Site 
(e.g. the Site Chair).
4.0
 
Project Information
4.1  
Has another IRB/HRPP reviewed this study or will another IRB/HRPP be reviewing this study?
* 
 If 
Yes, answer the questions according to the IRB/HRPP Determination.
  Yes   
  No
IRB Name
Review Date
Determination
No records have been added
4.2  
Is this a research study or a Compassionate Use/Emergency Use/HUD project?
* 
 Yes   
 No
4.3  What type of research is this?
Biomedical Research
Clinical trial (FDA regulated)
Behavioral Research

Educational Research
Psychosocial Research
Oral History
Other
4.4  Are you conducting this project in pursuit of a personal degree?
  Yes   
  No
4.6  
Is this human subjects research? (As defined by 32 CFR 219) 
* 
   Human subject means a living 
individual about whom an investigator (whether professional or student) conducting research: 
   (i) Obtains information or biospecimens through intervention or interaction with the individual, and 
uses, studies, or analyzes the information or biospecimens; or 
  (ii) Obtains, uses, studies, analyzes or generates identifiable private information or identifiable 
biospecimens.  
 Yes   
 No
4.7  
 Do you believe this human subjects research is exempt from IRB review?
*
  Yes   
  No
5.0
 
Personnel Details
5.1  List any Research Team members without EIRB access that are not previously entered in the protocol:
No records have been added
5.2  
Will you have a Research Monitor for this study?
Yes 
No 
N/A 
Research Monitor Qualifications
Ensure the individual has expertise consistent with the nature of risk(s) identified within your 
study and is independent of the team conducting the research.
Research Monitor Role:
Provide oversight throughout the investigation.  The monitor will work full-time at the study 
location and oversee the patient preoperative, intraoperative, and postoperative process.  The 
monitor will review data collection and analysis as well.  The monitor will ensure all informed 
consents are signed and all records suitably kept and stored securely.
If applicable, you may nominate an individual to serve as the Research Monitor:
David Moss
Selected Users

6.0
 
Data/Specimens
6.1  Does the study involve the use of existing data or specimens only (no interaction with human 
subjects)?
  Yes   
  No
7.0
 
Funding and Disclosures
7.1  Source of Funding:
Funding Source
Funding Type
Amount
No records have been added
Total amount of funding:
7.2  Do you or any other Investigator(s) have a disclosure of a personal interest or financial nature 
significant with sponsor(s), product(s), instrument(s) and/or company(ies) involved in this study?
  Yes   
  No
If Yes, complete and attach Conflict of Interest forms for all key personnel
8.0
 
Study Locations
8.1  Is this a collaborative or multi-site study? (e.g., are there any other institutions involved?)
  Yes   
  No
8.2  Study Facilities and Locations:
Institution Site Name
Site Role
FWA or DoD 
Assurance 
Number
Assurance 
Expiration 
Date
Is there an 
agreement?
IRB Reviewing 
for Site
Air 
Force
99MDG
/Nellis 
AFB
Performance 
site
DHA000004
02/15
/2026
:
NMCSD 
IRB
Other:
Other 
Institution 
Site
Site Role
FWA or DoD 
Assurance 
Number
FWA or DoD 
Expiration 
Date
Is there an 
agreement?
IRB Reviewing 
for Site
No records have been added
8.3  Are there international sites?

Attach international approval documents, if applicable, when prompted. Note: Ensure local 
research context has been considered
  Yes   
  No
8.4  Is this an OCONUS (Outside Continental United States) study?
  Yes   
  No
Select  the area of responsibility:
Have you obtained permission from that area of responsibility? (This is a requirement prior to 
study approval)
  Yes   
  No
9.0
 
Study Details
9.1  Key Words:
Provide up to 5 key words that identify the broad topic(s) of your study
Capsular Tension Ring; intraocular lens; ophthalmology; cataract surgery; toric lens
9.2  Background and Significance:
Include a literature review that describes in detail the rationale for conducting the study. Include 
descriptions of any preliminary studies and findings that led to the development of the 
protocol.  The background section should clearly support the choice of study variables and 
explain the basis for the research questions and/or study hypotheses.  This section establishes 
the relevance of the study and explains the applicability of its findings

This study has the potential to improve surgical outcomes in cataract surgery with toric 
intraocular lenses. Twenty million people have cataract surgery annually worldwide, and 
approximately 30% have visually significant astigmatism and are candidates for toric intraocular 
lenses. In turn, postoperative uncorrected visual acuity depends on the toric axis. For every 
degree of rotation away from the target axis, there is a 3.3% decrease in the astigmatism 
correction. This means that if the toric intraocular lens is rotated 10%, there is a 30% decrease 
in the correction of astigmatism. This generally negates the benefit of the toric lens, requiring 
correction for the refractive error.
 Implanting a capsular tension ring is a simple surgical 
1-4
technique that has the potential to reduce toric rotation and improve refractive error.
 
Instead of a round cornea (like a basketball), some patients have a more oblong cornea (like a 
football). This is called astigmatism, and it can affect whether patients require glasses or other 
refractive correction in order to see clearly. Toric intraocular lenses are FDA-approved for use 
during cataract surgery to correct refractive error due to corneal astigmatism. This improves 
patients’ refractive error and makes it less likely that they will need glasses after cataract 
surgery. These intraocular lenses are shaped to provide astigmatism correction at a marked axis 
denoted with dots on the surface of the lens. The lenses are rotated to the desired target axis 
after placement in the lens capsular bag during surgery. Sometimes the lenses rotate out of 
place after the surgery, which reduces the effectiveness of astigmatism correction.
 
Many factors have been shown to affect intraocular lens position: lens material, axial length of 
the eye, size of the capsulorrhexis, presence of posterior capsulotomy or asymmetric contraction 
of the capsular bag, viscoelastic removal, and final lens axis.  Some surgeons have questioned 
5
whether a capsular tension ring (CTR) can reduce the amount of rotation. The capsular tension 
ring (CTR) is a thin, curved implant composed of polymethylmethacrylate. It stabilizes the 
capsular bag, equally distributing tension to centralize and stabilize the bag when zonules are 
weakened or missing.
 
The FDA has granted an Investigational Device Exemption (IDE# G190139) to approve the use 
of capsular tension rings in this study. This is considered a significant risk investigational device 
that is being used during routine cataract surgery as part of a clinical investigation. This extends 
the use of this device for eyes with normal, intact zonules and a stable lens capsule for the 
purposes of this study.
 
Previous studies have looked at rotational stability of toric IOLs with capsular tension rings and 
found that CTR improve stability. Rastogi 
randomized 50 eyes to Auroflex toric IOL alone or 
et al 
toric IOL plus CTR.  The eyes with a CTR rotated less than the eyes without the CTR, and the 
5
difference was statistically significant (1.85 ± 1.72° in eyes with a CTR and 4.02 ± 2.04° in eyes 
without CTR, P-value = 0.003).
 
Several case reports and studies have looked at the effect of CTR in rotational stability in 
patients with axial myopia. Increasing axial length is associated with increased toric IOL rotation.6
Zhao 
 studied 36 eyes with axial myopia, in which 16 were treated with CTR and 18 without.
et al
7
Acrysof SN6ATY IQ toric intraocular lenses were used.  There was significantly less rotation with 
the use of CTR. A case report of two patients with high axial length demonstrated rotation when 
no CTR was inserted, but stability with use of the CTR.  One patient had an AcrySof lens made 
8
by Alcon Laboratories, Inc. and one patient had Tecnis toric lens made by Johnson & Johnson 
Vision. An additional case report described an eye in which two CTR were required to prevent 
rotation in an AcrySof lens.9
 
The lens material can impact the amount of rotation.  AcrySof toric intraocular lenses (Alcon 
Laboratories, Inc.) have been shown to rotate less than Tecnis toric intracoular lenses (Johson & 
Johnson Vision), although other brands may rotate even less than both of those.
 
1, 10 
Comparison has shown that Precizon toric lenses (Ophtec) has slightly less rotation than Tecnis.11
However, no prospective studies have been published to date using capsular tension rings with a 
newly available lens, the Tecnis Eyhance Toric II  lens (Johnson & Johnson Vision). Johnson & 
Johnson Vision toric intraocular lenses are widely used in the United States due to some of their 
unique properties, including a square-edge design that reduces posterior capsular opacification, 
ease of use, and excellent optics. Since more research is needed to determine whether capsular 
tension rings reduce intraocular lens rotation, and no research has been done with this technique 
using Johnson & Johnson intraocular lenses, it is worthwhile to study whether capsular tension 
rings may play a helpful role in reducing rotation in these lenses.
9.3  
Objectives/Specific Aims/Research Questions:

Describe the purpose and objective(s) of the study, specific aims, and/or research questions
/hypotheses
Null Hypothesis: The use of a capsular tension ring inside the capsular bag will not reduce the 
degree of rotation of the toric intraocular lens, compared to lenses implanted without a capsular 
tension ring.
Alternative Hypothesis: The use of a capsular tension ring inside the capsular bag will reduce 
the degree of rotation of the toric intraocular lens, compared to lenses implanted without a 
capsular tension ring.
 Determine whether the use of a capsular tension ring inside the capsular bag will 
Objective 1:
reduce the degree of rotation of the toric intraocular lens, compared to lenses implanted without 
a capsular tension ring.
9.4  Study Design:
Describe study design in one to two sentences (e.g., prospective, use of existing records/data
/specimens, observational, cross-sectional, interventional, randomized, placebo-controlled, 
cohort, etc.). Specify the phase – Phase I, II, III, or IV – for FDA-regulated investigational drug 
research
To investigate whether implantation of a capsular tension ring device will affect the degree of 
rotation of an implanted toric intraocular lens following cataract surgery.
9.5  Target Population:
Describe the population to whom the study findings will be generalized
Active duty and DoD beneficiaries aged 30 years or older undergoing cataract surgery
Corneal astigmatism ≥ 1.0 D and a surgical plan that includes a toric intraocular lens for 
astigmatism correction.
9.6  Benefit to the DoD:
State how this study will impact or be of benefit to the Department of Defense
Uncorrected visual acuity affects warfighter capability to function in combat.  Improving 
uncorrected visual acuity is a goal of military eye care, as evidenced by the robust military 
refractive surgery program and use of premium intraocular lenses, including toric lenses, at 
military treatment facilities. Although few active duty members require cataract surgery, those 
who do may benefit from the outcomes of this study in improving astigmatism correction. 
Improved visual outcomes in military retirees will also benefit readiness, as many former military 
members remain in the Inactive Ready Reserves, serve in the Reserves or National Guard, work 
as contractors on deployed locations overseas, or serve as mentors, leaders, and ambassadors in 
the community to serve military needs and mission requirements.
10.0
 
Study Procedures, Data Management, and Privacy
10.1  Study Procedures:
Describe step-by-step how the study will be conducted from beginning to end
The study is a prospective, subject-blinded investigation of whether implanting capsular tension 
rings with intraocular lenses affects rotational stability of the lens. Male and female Active Duty 
and DoD beneficiaries who satisfy the inclusion/exclusion criteria will be offered an opportunity to 
participate. They will be recruited from the ophthalmology clinic located at the Mike O’Callaghan 
Military Medical Center, 99MDG with prior verbal or written authorization from the patient, the 
attending physician will refer the patient to the Research Team to obtain more detailed 
information concerning the study. No research-related procedures will be implemented without 
the subject first signing an Informed Consent and HIPAA Authorization Document. Each eye will 

be assigned a unique study code via a random number generator called the Subject Identification 
code (001, 002, 003, etc) and randomized independently to the treatment or control group. All 
of the below items are research-related unless marked as ‘standard of care’:
 
This study has been identified as a significant risk device under a Food and Drug Administration 
(FDA) approved Investigational Device Exemption (#G190139).
 
Preoperative 
:
Screening
Obtained Informed Consent and HIPAA Authorization.
Record the date of birth, age, gender, race, ethnicity, DoD ID number, phone number(s) 
and e-mail addresses (used for scheduling). (standard of care)
Review ocular exam and ocular history to verify the Enrollment Criteria. This will include 
review of previous ophthalmology encounters, ocular history, ocular exam, refractive 
error, and corneal astigmatism. (standard of care)
Potential subjects will be fully informed of the risks of the study. They will be clearly 
informed that the study requires dilation at postoperative visits, which adds about 30 
minutes to the duration of the visit. 
One additional note on the number of visits described in this study: The ICD states that the 
subject may have seven outpatient visits for the study, yet five outpatient visits are described in 
the Protocol and ICD.  This is because patients with both eyes enrolled will require visits on 
Postoperative Day #1 and Postoperative Week #1 for each eye.  That is, the first eye will be 
checked on Postoperative Day #1 and Postoperative Week #1, then the patient will undergo 
surgery for the second eye.  There will then be an additional five postoperative visits after the 
second eye has surgery (Postoperative Day #1, Postoperative Week #1, Postoperative Month 
#1, Postoperative Month #3, and Postoperative Month #6).  Please see the lists below for 
clarification.Patient with one eye enrolled will attend:
Postoperative Day #1 visit
Postoperative Week #1
Postoperative Month #1
Postoperative Month #3
Postoperative Month #6
Patient with both eyes enrolled will attend:
Surgery for the first eye
Postoperative Day #1 visit for the first eye
Postoperative Week #1 visit for the first eye
Surgery for the second eye
Postoperative Day #1 visit for the second eye
Postoperative Week #1 visit for the second eye
Postoperative Month #1 visit for both eyes
Postoperative Month #3 visit for both eyes
Postoperative Month #6 visit for both eyes
Criteria for Enrollment of one or both eyes:
Criteria will be applied to each eye individually in order to determine if one or both eyes 
may be enrolled in the study.
Patients will be permitted to enroll both eyes only if both eyes meet all criteria. 
For example, if only one eye meets criteria (for example, one eye has a surgical plan that includes 
a toric IOL and the other eye doesn’t), then only one eye will be enrolled in the study. However, if 
the fellow eye also meets criteria, then both eyes will be enrolled in the study.
 
Lens Selection: The patients will undergo standard of care preoperative measurements and 
planning. The surgeon will evaluate preoperative measurements and use lens calculations, as 
well as a discussion with the patient, to identify whether a toric lens will be used and to 
determine the IOL power, cylinder, and target axis (standard of care). Preoperative 
measurements will be taken using IOL-Master 700, with the addition of the Pentacam and 
automatic keratometry as needed (standard of care). The toric lens used will be either Tecnis 
toric II or the Tecnis Eyhance Toric II intraocular lense (Johnson & Johnson Vision). The surgeon, 
in conjunction with a thorough discussion with the patient, will decide whether to use the Tecnis 
Toric II or the Tecnis Eyhance Toric II lens based on the patient’s pre-existing ocular conditions 
(prior corneal refractive surgery, irregular corneal astigmatism, severe corneal dystrophy, 
macular disease, optic atrophy, etc.), refractive goals, lens status of the other eye, and other 
preoperative factors.  All lenses will be used on label (standard of care).
 

Capsular Tension Ring Selection: The capsular tension rings used in this study will be the 
MORCHER® EYEJET® CTR Types 14, 14A, and 14C. MORCHER® EYEJET® CTR is a preloaded 
single-use injector plus capsular tension ring. It is available in two variations: for implantation 
clockwise (right), and for implantation counterclockwise (left). The clockwise (right) variation will 
be used in this study.
 
As recommended by the MORCHER® Instructions for Use, the anatomy of the eye, specifically 
the bulbous (axial) length, will be taken into account in the selection of the proper CTR size. CTR 
model 14C is 13.0mm in overall diameter and has a compressed diameter of 11 mm. It is 
intended for implantation in eyes with axial length of 24-28 mm. CTR model 14 is 12.3 mm in 
overall diameter and compresses to 10.0 mm. It is intended for implantation in eyes with axial 
length less than 28 mm. CTR model 14A is 14.5 mm in overall diameter and compresses to 12.0 
mm. It is intended for implantation in eyes with bulbous length greater than 28 mm. 
Measurements taken preoperatively on the IOL Master 700 will be used to determine the axial 
length of the study eye. If the axial length cannot be determined using the IOL Master 700, then 
the axial length measured by non-contact immersion A-scan will be used. For this study, the 
following selection protocol will be used (standard of care):
Axial length > 28.0 mm: CTR model 14A
Axial length 24.0-28.0 mm: CTR model 14C
Axial length < 24.0 mm: CTR model 14
Labeling: The outer box of the capsular tension rings used in this study will be clearly labeled 
with the following statement: “CAUTION—Investigational Use. Limited by Federal (or United 
States) law to investigational use.”  This is in accordance with FDA-approved labeling 
procedures.  In addition, the capsular tension ring selected for each eye will be packaged with 
the chosen intraocular lenses and labeled with the patient’s name to prevent another patient 
receiving the device accidentally.
 
Randomization: Each eye undergoing cataract surgery will be randomized into a control or 
 group. If both eyes meet enrollment criteria, then each eye will be randomized 
treatment
independently. For patients able to enroll both eyes into the study, potential outcomes could be: 
a. one eye could be randomized into the control group and one eye could be randomized into the 
treatment group, b) both eyes could be randomized into the control group, or c) both eyes could 
be randomized into the treatment group.
Control group: toric IOL only
Treatment group: toric IOL plus capsular tension ring
Assignment of the eye to the control or treatment group will be revealed during the cataract 
surgery at the point of potential capsular tension ring insertion. The surgeon and clinical staff 
(ophthalmic technicians and nurses) will not know whether the eye is in the treatment/control 
group until after the cataract has been removed and it is time for potential capsular tension ring 
placement. The eye will have been previously assigned to the control or treatment group using a 
random number generator by clinical research personnel, who are not involved in patient care. 
The group assignment will be documented in an opaque, sealed envelope, which will be present in 
the operating room at the time of surgery. The envelope will be opened by operating room staff 
after lens removal, and the surgeon will be informed. If the capsular tension ring is to be 
implanted, the correct size will be selected and verified, then implanted. 
 
It was recommended by the reviewers during the FDA Investigative Device Exemption (IDE) 
approval process that the assignment to the control or treatment group should be revealed as 
late as possible (that is, during surgery immediately before the capsular tension ring would need 
to be inserted).  This is to prevent the surgeon’s technique during the first part of the cataract 
surgery from influencing the outcome.  For example, there is a point during the surgery where 
the surgeon makes a round, even opening in the lens capsule called a capsulorrhexis.  The size 
and contour of the capsulorrhexis have been thought to influence lens position and rotation later 
on, and therefore would affect the results of the study.  It is important that the surgeon make a 
round, even capsulorrhexis opening without being influenced by whether the eye is assigned to 
the control or treatment group.  It may also be helpful to know that the decision to implant a 
capsular tension ring for its usual indication (weakened or missing zonules) is often made during 
surgery, when zonular weakness is identified.  The method of our study therefore mimics a 
common use of capsular tension rings.
 
Surgery: Patients will undergo manual phacoemulsification small-incision cataract surgery. The 
preoperative axis for toric placement will be marked while seated upright in the preoperative 
holding area. Standard of care phacoemulsification cataract surgery through a manual clear 
corneal incision will then take place. For the treatment group, after completing removal of the 
lens and cortex, the capsular bag will be inflated with cohesive viscoelastic and the capsular 
tension ring inserted. The intraocular lens will be placed in the capsular bag. The viscoelastic 

material will be removed, with attention given to careful removal behind the IOL. The lens will be 
rotated to the final target axis. Care will be taken to ensure the final rotation occurs in the 
direction of haptic orientation (clockwise). The techniques used in the surgery will be standard of 
care.
 
If both eyes are enrolled in the study, there will be a minimum time of 7 days between surgery 
dates.
 
If both eyes are enrolled in the study, then the visits on post-operative day #1 and post-
operative week #1 will involve dilation and slip lamp photography only on the eye which has 
most recently had surgery. The rest of the post-operative visits (month #1, month #3, month 
#6) will be combined visits with dilation and slit lamp photography for both enrolled eyes. Please 
see the description of the study visits, below.
During the pre-operative anesthesia visit, which is standard of care for this surgery, subjects will 
receive either a standard of care pregnancy test or be asked about their ability to become 
pregnant and/or lactating. If they are pregnant or lactating, they will not be eligible for this 
research study.
 
Post-Operative Day #1 Visit:
The eye enrolled in the study will be dilated and slit lamp photography taken using retro-
illumination. A standard of care postoperative evaluation will be performed, including 
checking visual acuity, eye pressure, slit lamp exam, and the rest of the postoperative 
evaluation.
Dilation and slit lamp photography will be performed only on the post-operative day #1 
eye.
 
Post-Operative Week #1 Visit (5-10 days after surgery):
The eye enrolled in the study will be dilated and slit lamp photography taken using retro-
illumination. A standard of care postoperative evaluation will be performed, including 
checking visual acuity, eye pressure, slit lamp exam, and the rest of the postoperative 
evaluation.
Dilation and slit lamp photography will be performed only on the post-operative week #1 
eye.
 
Post-Operative Month #1 Visit (4-6 weeks after surgery):
The eye(s) enrolled in the study will be dilated and slit lamp photography taken using 
retro-illumination. A standard of care postoperative evaluation will be performed, 
including checking visual acuity, eye pressure, slit lamp exam, and the rest of the 
postoperative evaluation.
If both eyes are enrolled, dilation and slit lamp photography will be performed on both 
eyes.
 
Post-Operative Month #3 Visit (75-120 days after surgery):
The eye(s) enrolled in the study will be dilated and slit lamp photography taken using 
retro-illumination. A standard of care postoperative evaluation will be performed, 
including checking visual acuity, eye pressure, slit lamp exam, and the rest of the 
postoperative evaluation.
If both eyes are enrolled, dilation and slit lamp photography will be performed on both 
eyes.
 
Post-Operative Month #6 Visit (165-210 days after surgery):
The eye(s) enrolled in the study will be dilated and slit lamp photography taken using 
retro-illumination. A standard of care postoperative evaluation will be performed, 
including checking visual acuity, eye pressure, slit lamp exam, and the rest of the 
postoperative evaluation.
If both eyes are enrolled, dilation and slit lamp photography will be performed on both 
eyes.If both eyes are enrolled, dilation and slit lamp photography will be performed on 
both eyes.

MISSED STUDY VISITS: Research subjects will remain in the study and be contacted 
for follow up visits up to the post-operative month #6 visit (up to 210 days), 
regardless of how many post op visits that they have missed.
 
If the scheduled visit does not take place or the dilation and slit lamp photography are not 
performed (for example, if the patient misses an appointment or has to leave prior to dilation 
and photography), then the patient will be contacted to return and the dilation/slit lamp 
photography completed at the next available opportunity. This may involve dilation/slit lamp 
photography at other intervals than noted above. In addition, if the patient comes in for any 
additional post-operative visits, the investigator may request additional dilation and/or slit lamp 
photography during the visit, if the patient is agreeable.
 
The capsular tension ring will not be visible in the slit lamp photos or during the eye exams. The 
patient will be blinded as to which eye is in the treatment or control group. The slit lamp photos 
will be de-identified and used to determine the axis of the toric IOL by evaluators blinded to the 
patient identity and control/treatment group.  The toric axis will be identified using either ImageJ 
(NIH) or Adobe Illustrator by measuring the angle between a straight line drawn across the toric 
axis markers and a straight line at the horizontal axis (0 degrees).
10.2  Data Collection:
Describe all the data variables, information to be collected, the source of the data, and how the 
data will be operationally measured.
Standard of care preoperative testing (to include optical biometry measurements with the IOL 
Master 700 platform, Pentacam, and autokeratometry measurements) will be performed.
 
Visual acuity will be tested in each eye individually and measured at distance using a Snellen 
Chart. Preoperatively, the best-corrected visual acuity will be recorded. Postoperatively, the 
uncorrected visual acuity will be recorded at post-operative day #1 and post-operative week #1, 
and both uncorrected and corrected visual acuity will be recorded at the subsequent 
postoperative visits.
 
Eye pressure will be measured using Goldmann applanation. If Goldmann applanation cannot be 
obtained (for example, due to poor patient cooperation), then the Avia Tonopen will be used. The 
method of measurement will be documented in the patient chart.
 
The ophthalmologist will perform slit lamp photography to document the toric axis. Anterior 
segment photographs will focus on the intraocular lens toric axis markings and will be taken 
using a Haag Streit camera and EyeSuite program. In addition, the ophthalmologist will use the 
slit lamp light beam to manually measure the toric axis and record it in the patient chart. This 
will serve as a secondary method to document toric axis.
The study data collected will be entered into a spreadsheet.
At the conclusion of the study, only coded information will be sent for analysis.
10.3  At any point in the study, will you request, use, or access health information in any form, including 
verbal, hard copy and electronic?
 Yes   
 No
10.4  Review the definitions below and respond to the following two questions.  If you are not sure of the 
answers, email 
 for assistance.
DHA.PrivacyBoard@mail.mil
   The 
 is 
Military Health System (MHS)
defined as all DoD health plans and DoD health care providers that are organized under the 
management authority of, or in the case of covered individual providers, assigned to or employed by, 
  
the Defense Health Agency (DHA), the Army, the Navy, or the Air Force  
 
MHS workforce members
are employees, volunteers, trainees, and other persons whose conduct, in the performance of work 
  
for the MHS, is under the direct control of the MHS, whether or not they are paid by the MHS.  MHS 
 are persons or entities that provide a service to the MHS and require protected 
business associates
health information (PHI) to provide the service.
Are you an MHS workforce member?

Yes, I am an MHS workforce member 
No, I am not an MHS workforce member 
Are you an MHS business associate?
Yes, I am an MHS business associate 
No, I am not an MHS business associate 
10.5  Have you consulted with an MHS data expert to determine the data elements required for your study?
Consulting with a data expert often saves time later in the compliance process because the data 
expert can advise on the data available in the numerous MHS information systems, the quality of 
that data and the methods for encrypting and collapsing data.  To schedule a consult with an 
MHS data expert, send an email to: (
)
DHA.PrivacyBoard@mail.mil
Yes, then complete the questions below according to the data consult 
No, then complete the questions below according to the best of your knowledge 
10.6  Indicate how you will request data from the MHS.  Select all that apply.
Talking with MHS health care providers or MHS health plans about specific research 
participants
Obtaining MHS hard copy records specific to research participants
Obtaining data from an MHS information system(s)
10.7  If you are obtaining data from an MHS information system(s), indicate whether you plan to receive a 
data extract or whether you plan to access an MHS information system directly to create a data set.
A data extract is when the MHS or a contractor provides the data set directly to the 
researcher.  When receiving a data set through data extract, the researcher may indicate 
whether the data elements should be provided as is, encrypted or collapsed.  In contrast to a 
data extract, access to an information system means that the researcher may directly access an 
MHS information system and create a data set for the research study
Data Extract
Access
10.8  Do you intend to request de-identified data from the MHS in your research study? 
There are different two methods for de-identifying data pursuant to HIPAA:
1) Safe Harbor Method: Removing all of the identifiers listed in Table 1 below, provided that the 
researcher does not have actual knowledge that the remaining data can be used alone or in 
combination with other information to identify the individual who is the subject of the information
2) Statistical Method: An expert, with appropriate knowledge of and experience with generally 
accepted statistical and scientific principles and methods for rendering information not 
individually identifiable, determines that the data is not individually identifiable
  Yes   
  No
10.9  Indicate the MHS information system(s) from which you will seek to obtain data
If you do not know which system(s) contains the data elements you need, refer to the Guide for 
DoD Researchers on Using MHS Data or request guidance from an MHS data expert at: DHA.
.
PrivacyBoard@mail.mil
 
Below is a list of commonly used MHS systems. If the system from which you seek to obtain 
data is not listed below, list the name of the system in the “Other MHS Systems” category below
PHI Systems:
MHS Information System
Requesting Data

No records have been added
PII-Only Systems:
MHS Information System
Requesting Data
No records have been added
De-Identified Data & Other Systems:
Information System
Requesting Data
Other MHS System (May include PII and/or 
PHI)
List other system here:
MHS Geneisis
:
Yes
10.10  Do you intend to merge or otherwise associate the requested data with data from any sources 
outside of the MHS, including other DoD systems that are not part of the MHS?
Yes, will merge data  
No, will not merge data 
10.11  Indicate the data elements about research participants or relatives, employers, or household 
members of the research participants that you will request from MHS hard copies or from MHS 
information systems. 
If you will merge data, also indicate non-MHS data elements about research participants or 
relatives, employers, or household members of the research participants that you will have access 
to in any form or medium.
Data Element(s)
MHS
Non-MHS Systems
MHS Hard Copies
1. Names
2. Postal address 
with only town, 
city, state and zip 
code
3. Postal address 
with all geographic 
subdivisions smaller 
than a state, 
including street 
address, city, 
county, precinct, 
zip code and their 
equivalent 
geocodes, except 
for the initial three 
digits of a zip code 
if, according to the 
current publicly 
available data from 
the Bureau of 
Census: 1) the 
geographic unit 
formed by 

combining all zip 
codes with the 
same three initial 
digits contains 
more than 20,000 
people; and 2) the 
initial three digits of 
a zip code for all 
such geographic 
units containing 
20,000 or fewer 
people is changed 
to 000
4. Dates including 
all elements 
(except year) 
directly related to 
an individual, 
including birth date, 
admission date, 
discharge date, and 
date of death
5. Ages over 89 
and all elements of 
dates (including 
year) indicative of 
such age, unless 
you will only 
request a single 
category of “age 90 
or older”
6. Telephone 
numbers
7. Fax numbers
8. Electronic mail 
addresses
9. Social Security 
numbers (SSNs)
10. Medical record 
numbers
11. Health plan 
beneficiary numbers
12. Account 
numbers
13. Certificate
/license numbers

14. Vehicle 
identifiers and 
serial numbers, 
including license 
plate numbers
15. Device 
identifiers and 
serial numbers
16. Web Universal 
Resource Locators 
(URLs)
17. Internet 
Protocol (IP) 
address numbers
18. Biometric 
identifiers, 
including finger and 
voice prints
19. Full-face 
photographic 
images and any 
comparable images
20. Any other 
unique identifying 
number, 
characteristic, or 
code (Diagnosis, 
DEERS ID, EDI-PI, 
Rank)
If you are obtaining SSNs, provide a justification as to why and explain why a substitute cannot 
be used
10.12  Do you believe it is possible for the MHS data to become identifiable because of triangulation, a 
small cell size, or any unique data element(s)?
Triangulation means using different data elements that are not themselves identifiable but that 
when combined can be used to identify an individual. For example, triangulation would use rank 
and race together to determine the identity of an individual with a particular health condition.
 
Small cell size means that there is only a small number of eligible individuals that satisfy the 
category description. Guidance for acceptable cell size is available from the Centers for Medicare 
and Medicaid Services. For example, the rank category of four star generals with a particular 
diagnosis may be less than 30, so the rank category may need to be expanded to include lower 
ranks.
 
A unique data element includes any unique features that are not explicitly enumerated in the 
categories of data in rows 1 – 20 of the table above (in Section 10.10), but that could be used to 
identify an individual. Unique data elements include characteristics that are not themselves 

identifying, such as the rank of general or admiral, or a race or gender, but within the context of 
other information could be identifiable.
Yes, I believe there is a reasonable possibility the MHS data will become identifiable 
No, I believe there is no reasonable possibility the MHS data will become identifiable 
10.13  Have you completed and uploaded an appropriate HIPAA document ( i.e. HIPAA Authorization will 
be obtained or Waiver/alteration of HIPAA Authorization is being requested)?
Yes 
No 
N/A 
10.14  Managing Data (Data Management and/or Sharing Plan) and/or Human Biological Specimens for 
this Study:
Include in this section the plan for acquiring data (both electronic and hard copy), access during 
the study, data/specimen storage and length of time stored, shipment/transmission, and the 
plan for storage and final disposition at the conclusion of the study. Describe any data 
agreements in place for accessing data within and/or outside of your institution (e.g., Data 
Sharing Agreement, Data Use Agreement, Business Agreements, etc.)
We are obtaining data for this study directly from the subjects during their research visits. 
During the study, the Informed Consents, HIPAA Authorization Documents, source documents, 
participant registration documents, identifiable Master Key, and any other study documents 
utilized during the study will be stored in a locked cabinet or electronically on a CAC-enabled 
government computer and password protected.
 Medical records will be annotated with ICD-10 code Z00.6 to reflect the subjects’ participation in 
a research study, in which they are receiving a research-related treatment intervention.
 Long-term storage: When the IRB Study Closure Letter has been obtained from the IRB, the 
Informed Consents, HIPAA Authorization Documents, source documents, participant registration 
documents, identifiable Master Key, and any other study documents utilized during the study will 
be scanned into a CAC-enabled government computer and electronically maintained for a 
minimum of 6 years.
10.15  Managing Data (Data Management and/or Sharing Plan) and/or Human Biological Specimens for 
Future Research:
If the study involves collecting, storing, or banking human specimens, data, or documents 
(either by the Investigator or through an established repository) for FUTURE research, address. 
How the specimens/data will be used, where and how data/specimens will be stored (including 
shipping procedures, storage plan, etc.), whether and how consent will be obtained, procedures 
that will fulfill subjects’ request as stated in the consent, whether subjects may withdraw their 
data/specimens from storage, whether and how subjects may be recontacted for future research 
and given the option to decline, whether there will be genetic testing on the specimens, who will 
have access to the data/specimens, and the linkage, the length of time that data/specimens will 
be stored and conditions under which data/specimens will be destroyed.
Subjects will be asked to consent to have their coded research data placed in the “Mike 
O'Callaghan Military Medical Center General Research Data Repository” (FWH20180064E), the 
coded data will be retained for possible use in future research.  Subjects may choose either to 
not allow any further use of their coded data or give consent now for the use of the coded data 
to be used in future studies.  This future research may be in the same area as the original study 
or it may be for a different kind of study.  Any future research using retained data will require a 
research protocol for the proposed study approved by an Institutional Review Board or other 
authorized official responsible for protecting human subjects of research.
11.0
 
Statistical/Data Analysis Plan

11.1  Statistical Considerations:
List the statistical methods to be used to address the primary and secondary objectives, specific 
aims, and/or research hypotheses.  Explain how missing data and outliers will be handled in the 
analysis.  The analysis plan should be consistent with the study objectives.  Include any sub-
group analyses (e.g., gender or age group).  Specify statistical methods and variables for each 
analysis.  Describe how confounding variables will be controlled in the data analysis
The primary outcome and dependent variable will be the degree of toric rotation away from the 
target axis, and the time point of primary endpoint analysis will be when data for the last 
repeated measurement at 6 months has been obtained. The main treatment effect is a control 
group receiving a toric IOL only (Group 1) and a treatment group receiving a toric IOL plus 
capsular tension ring (Group 2). The statistical null hypotheses is as follows:
 
H01 — there is no difference in means of the degree of toric rotation away from the target axis 
between control and treatment groups
 
Subjects will be a random sample of left or right eyes of male and female patients seen in one 
Air Force medical treatment facility. The patients are presumed to be randomly selected from the 
population of patients obtaining similar care at this and other Air Force medical treatment 
facilities.
 
The study is organized as a mixed effects, randomized design. Subject (eye) is a random effect, 
as the patients whose eyes are the subjects of this study are presumed to have been randomly 
elected to obtain this treatment from the population of patients obtaining similar care at these 
Air Force medical treatment facilities, and the eyes are randomly assigned to treatment or 
control groups. Treatment is a fixed effect, as the effect of the intraocular lens and capsular 
tension ring cannot be generalized to other brands of toric intraocular lens or capsular tension 
rings.
 
Reference 5 states eyes treated with a CTR rotated a mean 1.85°(1.72 SD) and eyes without a 
CTR rotated a mean 4.02°(2.04 SD). The minimum clinically significant difference of toric 
rotation away from the target axis the researchers wish to detect in this study is 1.85°. Using 
these parameters, a priori power for a repeated measures n analysis of variance (rANOVA) was 
assessed using G*Power Version 3.1.9.3. (12). The results indicate 50 subjects (eyes) will have 
a power of 0.957 at = 0.05 to detect this minimum clinically significant difference between the 
treatment groups.
 
Total sample and treatment group means, standard deviations, medians, interquartile ranges 
(IQR) and ranges will be calculated for interval variables. Frequency distributions will be 
produced for nominal and ordinal variables. Visual acuity, toric power, intended toric axis, and 
other variables will be included in the analysis.
 
The null hypothesis, H01, will be tested by a mixed effects repeated measures analysis of 
variance (rANOVA) using a general linear model, yij= 0+ 1xij+ 2tij+ 0i+ ij , where x is the main 
treatment effect, t is time of repeated measure, and 0i represents the influence of individual i on 
his/her repeated observations.
 
Mr. Danny Sharon, Senior Research Biostatistician Subject Matter Expert for Clinical Research 
Management under contracts OMNI 0004 3-82 and OMNI 0005 3-126, is the statistical consultant 
supporting this study. Statistical analysis will be performed with R Version 3.5.1. (13)
11.2  Sample Size:
50 eyes (approximately 25 eyes in each group) -- We are enrolling by number of eyes. If 
subjects have one eye that meets enrollment criteria, then that eye will be randomized into the 
treatment or control group. If both eyes meet enrollment criteria, then each eye will be 
randomized independently.
11.3  Total number of subjects requested (including records and specimens):
50
11.4  If you are recruiting by study arm, please identify the arms of the study and how many subjects will 
be enrolled in each arm

Randomization: Each eye undergoing cataract surgery will be randomized into a control or 
treatment group. If both eyes meet enrollment criteria, then each eye will be randomized 
independently. For patients able to enroll both eyes into the study, potential outcomes could be: 
a. one eye could be randomized into the control group and one eye could be randomized into the 
treatment group, b) both eyes could be randomized into the control group, or c) both eyes could 
be randomized into the treatment group.
· Control group: toric IOL only
· Treatment group: toric IOL plus capsular tension ring
Assignment of the eye to the control or treatment group will be revealed during the cataract 
surgery at the point of potential capsular tension ring insertion. The surgeon and clinical staff 
(ophthalmic technicians and nurses) will not know whether the eye is in the treatment/control 
group until after the cataract has been removed and it is time for potential capsular tension ring 
placement. The eye will have been previously assigned to the control or treatment group using a 
random number generator by clinical research personnel, who are not involved in patient care. 
The group assignment will be documented in an opaque, sealed envelope, which will be present 
in the operating room at the time of surgery. The envelope will be opened by operating room 
staff after lens removal, and the surgeon will be informed. If the capsular tension ring is to be 
implanted, the correct size will be selected and verified, then implanted.
11.5  Please provide a justification for your sample size
Subjects will be a random sample of left or right eyes of male and female patients seen in one 
Air Force medical treatment facility. The patients are presumed to be randomly selected from the 
population of patients obtaining care at this Air Force medical treatment facilities.
 
The study is organized as a mixed effects, randomized design. Subject (eye) is a random effect, 
as the patients whose eyes are the subjects of this study are presumed to have been randomly 
selected to obtain this treatment from a population of patients obtaining care at this Air Force 
medical treatment facility, and the subjects (eyes) are randomly assigned to treatment or control 
groups. Treatment is a fixed effect, as the effect of the intraocular lens and capsular tension ring 
cannot be generalized to other brands of toric intraocular lens or capsular tension rings.
 
Reference 5 states eyes treated with a CTR rotated a mean 1.85°(1.72 SD) and eyes without a 
CTR rotated a mean 4.02°(2.04 SD). The minimum clinically significant difference of toric 
rotation away from the target axis the researchers wish to detect in this study is 1.85°. Using 
these parameters, a priori power for a repeated measures n analysis of variance (rANOVA) was 
assessed using G*Power Version 3.1.9.3. (12). The results indicate 50 subjects (eyes) will have 
a power of 0.957 at = 0.05 to detect this minimum clinically significant difference between the 
treatment groups.
11.6  Data Analysis Plan: Complete description: Background, Objectives, Design, Step by Step how the 
project is going to be done, Data analysis plan:

The primary outcome and dependent variable will be the degree of toric rotation away from the 
target axis, and the time point of primary endpoint analysis will be when data for the last 
repeated measurement at 6 months has been obtained. The main treatment effect is a control 
group receiving a toric IOL only (Group 1) and a treatment group receiving a toric IOL plus 
capsular tension ring (Group 2). The statistical null hypotheses is as follows:
 
H01 — there is no difference in means of the degree of toric rotation away from the target axis 
between control and treatment groups
 
Subjects will be a random sample of left or right eyes of male and female patients seen in one 
Air Force medical treatment facility. The patients are presumed to be randomly selected from the 
population of patients obtaining care at this Air Force medical treatment facilities.
 
The study is organized as a mixed effects, randomized design. Subject (eye) is a random effect, 
as the patients whose eyes are the subjects of this study are presumed to have been randomly 
elected to obtain this treatment from the population of patients obtaining similar care at these 
Air Force medical treatment facilities, and the subjects (eyes) are randomly assigned to 
treatment or control groups. Treatment is a fixed effect, as the effect of the intraocular lens and 
capsular tension ring cannot be generalized to other brands of toric intraocular lens or capsular 
tension rings.
 
Reference 5 states eyes treated with a CTR rotated a mean 1.85°(1.72 SD) and eyes without a 
CTR rotated a mean 4.02°(2.04 SD). The minimum clinically significant difference of toric 
rotation away from the target axis the researchers wish to detect in this study is 1.85°. Using 
these parameters, a priori power for a repeated measures n analysis of variance (rANOVA) was 
assessed using G*Power Version 3.1.9.3. (12). The results indicate 50 subjects (eyes) will have 
a power of 0.957 at = 0.05 to detect this minimum clinically significant difference between the 
treatment groups.
 
Total sample and treatment group means, standard deviations, medians, interquartile ranges 
(IQR) and ranges will be calculated for interval variables. Frequency distributions will be 
produced for nominal and ordinal variables.
 
The null hypothesis, H01, will be tested by a mixed effects repeated measures analysis of 
variance (rANOVA) using a general linear model, yij= 0+ 1xij+ 2tij+ 0i+ ij , where x is the main 
treatment effect, t is time of repeated measure, and 0i represents the influence of individual i on 
his/her repeated observations.
 
 
Mr. Danny Sharon, Senior Research Biostatistician Subject Matter Expert for Clinical Research 
Management under contracts OMNI 0004 3-82 and OMNI 0005 3-126, is the statistical consultant 
supporting this study. Statistical analysis will be performed with R Version 3.5.1. (13)
12.0
 
Participant Information
12.1  Subject Population:
Active duty and DoD beneficiaries aged 30 years or older undergoing cataract surgery. Patients 
who are pregnant or lactating will be excluded because the risks of surgery and post-operative 
medication to the unborn fetus are unknown.  Patients under 30 years of age will not be included 
because they are likely to have congenital, pediatric, or juvenile-onset cataracts, which is outside 
the scope of this study. Corneal astigmatism ≥ 1.0 D and a surgical plan that includes a toric 
intraocular lens for astigmatism correction.
12.2  Age Range:
Check all the boxes that apply. if the age range of potential subjects (specimens, records) does 
not match the range(s) selected, please specify in the text box.
0-17
18-24
25-34
35-44

45-54
55-64
65-74
75+
12.3  Gender:
Male
Female
Other
12.4  Special categories, check all that apply
Minors /Children
Students
Employees - Civilian
Employees - Contractor
Resident/trainee
Cadets /Midshipmen
Active Duty Military Personnel
Wounded Warriors
Economically Disadvantaged Persons
Educationally Disadvantaged Persons
Physically Challenged (Physical challenges include visual and/or auditory impairment)
Persons with Impaired Decisional Capacity
Prisoners
Pregnant Women, Fetuses, and Neonates
Non-English Speakers
International Research involving Foreign Nationals - Headquarters Review is necessary
You must also consider the requirements of DoDI 3216.02, Enclosure 3, paragraph 7.e.
12.5  Inclusion Criteria:
Order 
Number
Criteria
1 
Active duty and DoD beneficiaries aged 30 years or older undergoing 
cataract surgery
Corneal astigmatism = 1.0 D and a surgical plan that includes a toric 
intraocular lens for astigmatism correction.
The lenses used will be the Tecnis Toric II IOL and the Eyhance 
Toric II IOL (Johnson & Johnson Vision). The lenses will be used on 
label.
No observed zonular or capsular problems prior to, or at the time of, 
capsular tension ring insertion
 
12.6  Exclusion Criteria:
Order 
Number
Criteria
Patients who are pregnant or lactating

1 
Patients undergoing cataract surgery who do not have corneal astigmatism 
=1.0 D.
Any observed zonular or capsular problems prior to, or at the time of, 
capsular tension ring insertion.
Pre-existing ocular conditions, including:
Pseudoexfoliation syndrome in one or both eyes
Prior incisional ocular surgery
Lens subluxation
Poor dilation or inability to position at the slit lamp (making 
postoperative outcome measurements difficult or impossible)
Plans for extensive travel or to move away during the postoperative 
evaluation period
Other conditions that would influence the capsule or lens positioning
Surgical plan that includes other procedures at the time of initial cataract 
surgery, such as Limbal Relaxing Incisions (LRIs), Micro-Incisional 
Glaucoma Surgery (MIGS), etc.
Legally Authorized Representatives will not be utilized in this study
 
13.0
 
Recruitment and Consent
13.1  Please describe the recruitment process, including how subjects will be identified and selected for 
the study.
Providers will ask their patients if they are interested in being referred to the research 
department. If the subject agrees, the provider will provide the research department their name 
and phone number and/or give the patients the contact information for the research department. 
We will also post advertisements around the hospital. Some patients may be patients of the PI or 
AI; however, they will have another study staff recruit their patients to prevent any 
misconception of coercion or undue influence.
13.2  Compensation for Participation:
Subjects will not be paid for their participation.
13.3  Please describe the pre-screening process. If no pre-screening, enter Not Applicable in the text editor
N/A
13.4  Consent Process:   Revised Common Rule, Section 219.116:  General requirements for informed 
consent, whether written or oral, are set forth in this paragraph and apply to consent obtained in 
accordance with the requirements set forth in paragraphs (b) through (d) of this section. Broad 
consent may be obtained in lieu of informed consent obtained in accordance with paragraphs (b) and 
(c) of this section only with respect to the storage, maintenance, and secondary research uses of 
identifiable private information and identifiable biospecimens.
Are you requesting a waiver or alteration of informed consent?
  Yes   
  No
Please explain the consent process:
Informed Consent and HIPAA Authorization will be sought in advance of any screening and study-
related procedures from each prospective study subject and appropriately documented in 
accordance with 32 CFR 219.117. The subject may decline to consent without prejudice. At the 
subjects’ discretion, they may take the ICD home to discuss further with family members or 
another physician prior to making a decision. If the subject consents, a copy of the signed ICD 
and HIPAA Authorization Document will be given to the subject. 

13.5  DoDI 3216.02 requires an ombudsman to be present during recruitment briefings when research 
involves greater than minimal risk and recruitment of Service members occurs in a group setting. If 
applicable, you may nominate an individual to serve as the ombudsman.
N/A 
Propose ombudsman 
13.6  Withdrawal from Study Participation:
Explain the process for withdrawal and specify whether or not the subjects will be given the 
opportunity to withdraw their data their data/specimens in the event they wish to withdraw from 
the study
If a participant first agrees to participate and then changes their mind, they are free to withdraw 
consent and discontinue participation at any time. Their decision will not affect their ability to 
receive medical care and will not be penalized or lose any benefits to which they would otherwise 
be entitled. There are no risks from withdrawing. They will be advised in the Informed Consent 
process that if they decide to withdraw from the study early, we will ask them to discuss their 
decision with the study staff. The researcher may withdraw them from the study prior to the 
study’s end without their consent for one or more of the following reasons: Failure to follow the 
instructions of the researchers and study staff. The researcher decides that continuing their 
participation is not in their best interests. The study is cancelled. Other administrative reasons. 
Unanticipated circumstances. They become Pregnant or begin lactating. If they lose their status 
as a military health care beneficiary, they can no longer be included in the study.
 
Patients will be discontinued from the study if intraoperative complications or concerns are noted 
PRIOR to capsular tension ring insertion.
Intraoperative complications may include:
capsular bag tears or rents
anterior vitrectomy
phacodonesis
damaged zonules
use of non-toric intraocular lens
other intraoperative complications that would influence capsule or lens positioning or 
stability
Patients will continue to be enrolled in the study to further characterize the safety of the 
investigational device and treatment if intraoperative complications occur DURING OR AFTER the 
point of possible capsular tension ring insertion. This includes secondary surgical interventions 
such as repositioning of the IOL. These eyes will not be included in the data analysis after this 
point.
14.0
 
Risks and Benefits
14.1  
Risks of Harm:
Identify all research-related risks of harm to which the subject will be exposed for each research 
procedure or intervention as a result of participation in this study.  Consider the risks of breach 
of confidentiality, psychological, legal, social, and economic risks as well as physical risks.  Do 
not describe risks from standard care procedures; only describe risks from procedures done for 
research purposes

The risks listed below are inherent in cataract surgery, the use of a toric intraocular lens, and the 
use of a capsular tension device. 
 
More common and not serious::
Blurry vision
Photosensitivity (light sensitivity)
Posterior capsular opacity
Less common and 
:
more serious
Intraocular inflammation
Elevated intraocular pressure
Capsular tears
Iris tears or atrophy
Intraocular floppy iris syndrome (IFIS)
Vitreous problems
Floaters
Dropped lens
Decentered intraocular lens
Cortical remnants
Optic atrophy
Deposits on intraocular lens
Posterior synechiae
Glaucoma
Iridodonesis
Phacodonesis
Corneal edema
Fibrin in pupil
Cystoid macular edema (retinal swelling)
Need for additional surgery
Aphakia
Retinal tears or detachment
Loss of vision
Anterior vitrectomy
Dropped lens
Rotated lens
Need for spectacle correction
Astigmatism
Accidental breach of confidentiality.
 
A specific risk inherent to the capsular tension ring device is that it is also possible that the 
capsular tension ring could be placed incorrectly into the wrong part of the eye (sulcus or 
anterior chamber), which may lead to damage to the surrounding structures. 
14.2  
Measures to Minimize Risks of Harm (Precautions, safeguards):
For each research procedure or intervention, describe all measures to minimize and/or eliminate 
risk of harms to subjects and study personnel
The treatment intervention involves placement of a capsular tension ring. Risks will be minimized 
by the surgeons being experienced with capsular tension ring placement and techniques. Risks 
will also be minimized by excluding patients with any conditions such as pseudoexfoliation, 
capsular tears, or other surgical complications. If at any time one of the patients experiences a 
complication, the surgeon will address it surgically or during the postoperative period, depending 
on the treatment required.
 
If at any time the patient reports a side effect, they will be referred to one of the Investigators 
for care.
14.3  
Confidentiality Protections (for research records, data and/or specimens):

Describe in detail the plan to maintain confidentiality of the research data, specimens, and 
records throughout the study and at its conclusion (e.g., destruction, long term storage, or 
banking). Explain the plan for securing the data (e.g., use of passwords, encryption, secure 
servers, firewalls, and other appropriate methods). If data will be shared electronically with 
other team members/collaborators outside the institution, describe the method of transmission 
and safeguards to maintain confidentiality. Explain whether this study may collect information 
that State or Federal law requires to be reported to other officials or ethically requires action, e.
g., child or spouse abuse
During the study, the Informed Consents, HIPAA Authorization Documents, source documents, 
participant registration documents, identifiable Master Key, and any other study documents 
utilized during the study will be stored in a locked cabinet or electronically on a CAC-enabled 
government computer and password protected.
Medical records will be annotated with ICD-10 code Z00.6 to reflect the subjects’ participation in 
a research study, in which they are receiving a research-related treatment intervention.
Long-term storage: When the IRB Study Closure Letter has been obtained from the IRB, the 
Informed Consents, HIPAA Authorization Documents, source documents, participant registration 
documents, identifiable Master Key, and any other study documents utilized during the study will 
be scanned into a CAC-enabled government computer and electronically maintained for a 
minimum of 6 years.
For subjects who consent to have their coded research data placed in the “Mike O’Callaghan 
Military Medical Center General Research Data Repository” (FWH20180064E), the coded data will 
be retained for future use. The coded research data will not be utilized for further research 
activity beyond the protocol stipulations without additional IRB approval.
14.4  
Potential Benefits:
Describe any real and potential benefits of the research to the subject and any potential benefits 
to a specific community or society
If the individuals in the research are considered experimental subjects (per 10 USC 980), and 
they cannot provide their own consent, the protocol must describe the intent to directly benefit 
all subjects
Eyes treated with capsular tension rings may experience less risk of the toric lens rotating out of 
its intended alignment. This would lead to an improvement in refractive outcome and may 
reduce their dependence on glasses postoperatively. They may also have a reduced risk of 
undergoing a second surgery to adjust the position of the toric intraocular lens. None of these 
benefits are guaranteed.
14.5  
Privacy for Subjects:
Describe the measures to protect subject’s privacy during recruitment, the consent process, and 
all research activities, etc.
During the study, the research consents, HIPAA Authorization Documents, participant 
registration forms, identifiable Master Key, and any other study documents utilized during the 
study will be stored in a locked cabinet or electronically on a CAC-enabled government computer 
and password protected.
14.6  
Incidental or Unexpected Findings:

A.  
B.  
C.  
D.  
Describe the plan to address incidental findings and unexpected findings about individuals from 
screening to the end of the subject’s participation in the research. In cases where the subject 
could possibly benefit medically or otherwise from the information, state whether or not the 
results of screening, research participation, research tests, etc., will be shared with subjects or 
their primary care provider. State whether the researcher is obligated or mandated to report 
results to appropriate military or civilian authorities and explain the potential impact on the 
subject
If significant new findings develop during the course of this study that may relate to subjects’ 
decision to continue to participate in the study, they will be informed and/or their PCM will be 
notified.
15.0
 
Study Monitoring
15.1  Your study requires either Data and Safety Monitoring Plan (DSMP) or a Data and Safety Monitoring 
Board (DSMB).
DSMP 
DSMB 
Both 
Not Applicable 
16.0
 
Reportable Events
16.1  Reportable Events: Consult with the research office at your institution to ensure requirements are 
met. Describe plans for reporting unexpected adverse events and unanticipated problems. Address 
how unexpected adverse events will be identified, who will report, how often adverse events and 
unanticipated problems will be reviewed to determine if any changes to the protocol or consent form 
are needed and the scale that will be used to grade the severity of the adverse event. 
Consult with the research office at your institution to ensure requirements are met
 
• Describe plans for reporting expected adverse events. Identify what the expected adverse 
events will be for this study, describe the likelihood (frequency, severity, reversibility, short-
term management and any long-term implications of each expected event)
 
• Describe plans for reporting unexpected adverse events and unanticipated problems. Address 
how unexpected adverse events will be identified, who will report, how often adverse events and 
unanticipated problems will be reviewed to determine if any changes to the research protocol or 
consent form are needed and the scale that will be used to grade the severity of the adverse 
event
Adverse Events (AEs) are defined as “any untoward medical or surgical occurrence in the 
study eye, which does not necessarily have a causal relationship with the trial 
intervention.” AEs will be assessed at all visits and during the surgical procedure. AEs will 
be assessed using all available clinical modalities, including but not limited to: patient 
history, slit lamp examination, intra-operative observation, and ancillary clinical testing 
such as Optical Coherence Tomography (OCT), visual corneal topography, refraction, etc.
All AEs and Unanticipated Adverse Effects will be documented and records maintained, 
regardless of whether thought to be device-related, procedure/operation-related, or not.
Adverse Event: The investigator(s) on this protocol will complete an Adverse Event 
Reporting Form (also referred to as a Case Report Form) for each AE. The form will be 
reviewed by the Research Monitor and submitted to the governing IRB and FDA as 
consistent with all required policies.
Serious Adverse Event: An adverse event where the outcome is one of the following:
-Death

E.  
F.  
-Life-threatening, where the patient was at substantial risk of dying or continued use of the 
product might have resulted in death
-Hospitalization or prolongation of an existing hospitalization
-Disability or permanent damage, interfering with the patient’s ability to conduct normal life 
functions
-Congenital anomaly or birth defect
-Required intervention to prevent permanent impairment
Unanticipated Adverse Device Effect: An effect not outlined in study documents or an 
event that occurs more often than expected. Required policies as outlined in 21 CFR 
812.150 (a1) (b) involve submitting unanticipated adverse device effects to the FDA and 
IRB, with investigators required to submit the unanticipated ADE report less than or equal 
to working days of their own notification. Investigators may be required by the FDA to 
submit follow-up reports regarding an UADE. In the case of this proposed study, “The 
Investigation of Capsular Tension Rings in Intraocular Lens Rotation,” the sponsor is the 
investigator, eliminating one of the reporting steps. An AE may be reclassified as an UADE 
in the event the effect is revealed to be more frequent than expected.
Descriptions and Definitions of AEs:
-Relationship to device: definite, probably, possible, unlikely, etc.
-Relationship of event to implantation procedure or operation: definite, probably, 
possible, unlikely, etc.
-Severity of the event: mild, moderate, severe, vision-threatening, lifethreatening, etc.
-Subsequent treatments or interventions required: none, medical therapy, surgical or 
procedural intervention, hospitalization, etc.
-Resolution status: resolved without sequalae, resolved with chronic sequelae, ongoing 
without sequelae, ongoing with sequelae, etc.
 
Withdrawal of subjects due to adverse events: Patients will be discontinued from the study if any 
intraoperative complications or adverse events are noted prior to capsular tension ring insertion. 
Intraoperative complications may include capsular bag tears or rents, anterior vitrectomy, 
phacodonesis, damaged zonules, use of non-toric lens, or other intraoperative complications that 
would influence capsular bag or lens positioning or stability.
 
If intraoperative complications or adverse events occur after the point of possible capsular 
tension ring insertion, the patient will continue to be enrolled in the study to further characterize 
the safety of the investigational device and treatment. Complete and thorough pre-, intra-, and 
post-operative care will be provided for all patients regardless of enrollment status in the study. 
All patients, including patients who experience an adverse event, will continue in the study and 
receive appropriate treatment and/or monitoring throughout the duration required based on their 
clinical needs, regardless of whether the study eye is discontinued or an adverse event occurs.
17.0
 
Equipment/non-FDA Regulated Devices
17.1  Does the study involve the use of any unique non-medical devices/equipment?
  Yes   
  No
18.0
 
FDA-Regulated Products
18.1  Will any drugs, dietary supplements, biologics, or devices be utilized in this study?
Drugs
Dietary Supplements
Biologics
Devices
N/A
18.3  Device Details:

1.  
2.  
3.  
4.  
5.  
6.  
Are device(s) in this research being used in accordance to the approved labeling?
Are device(s) in this research being used in a manner other than its approved labeling?
When adding a device indicate in the details section of the device if the use is either used in 
accordance to the approved labeling or in a manner other than it's approved labeling
View Details
Device Name
MORCHER® capsular tension ring  
Manufacturer/Supplier of 
Device
MORCHER® EYEJET® CTR Types 14, 14A, and 14C 
Where will the Devices Be 
Stored
stored separately from clinic stock and labeled in 
accordance with FDA Investigational Device Exemption 
(IDE# G190139) 
Will Devices be supplied at no 
Cost
Yes 
Is this a HUD (HDE)
No 
HDE Number
 
Who holds the IDE
N/A  
IDE details
FDA approved Investigational Device Exemption (IDE# 
G190139)  
18.4  Reporting Requirements for FDA-regulated research under IND and IDE:
Describe the process for complying with FDA regulatory requirements for adverse event 
reporting and adverse device effects reporting to the sponsor
Adverse Events (AEs) are defined as “any untoward medical or surgical occurrence in the 
study eye, which does not necessarily have a causal relationship with the trial 
intervention.” AEs will be assessed at all visits and during the surgical procedure. AEs will 
be assessed using all available clinical modalities, including but not limited to: patient 
history, slit lamp examination, intra-operative observation, and ancillary clinical testing 
such as Optical Coherence Tomography (OCT), visual corneal topography, refraction, etc.
All AEs and Unanticipated Adverse Effects will be documented and records maintained, 
regardless of whether thought to be device-related, procedure/operation-related, or not.
Adverse Event: The investigator(s) on this protocol will complete an Adverse Event 
Reporting Form (also referred to as a Case Report Form) for each AE. The form will be 
reviewed by the Research Monitor and submitted to the governing IRB and FDA as 
consistent with all required policies.
Serious Adverse Event: An adverse event where the outcome is one of the following:
1. Death
2. Life-threatening, where the patient was at substantial risk of dying or 
continued use of the product might have resulted in death
3. Hospitalization or prolongation of an existing hospitalization
4. Disability or permanent damage, interfering with the patient’s ability to 
conduct normal life functions
5. Congenital anomaly or birth defect
6. Required intervention to prevent permanent impairment
Unanticipated Adverse Device Effect: An effect not outlined in study documents or an 
event that occurs more often than expected. Required policies as outlined in 21 CFR 
812.150 (a1) (b) involve submitting unanticipated adverse device effects to the FDA and 
IRB, with investigators required to submit the unanticipated ADE report less than or equal 
to 10 working days of their own notification. Investigators may be required by the FDA to 
submit follow-up reports regarding an UADE. In the case of this proposed study, “The 
Investigation of Capsular Tension Rings in Intraocular Lens Rotation,” the sponsor is the 
investigator, eliminating one of the reporting steps. An AE may be reclassified as an UADE 
in the event the effect is revealed to be more frequent than expected.
Descriptions and Definitions of AEs:

a.  
b.  
c.  
d.  
1.  
2.  
3.  
4.  
5.  
Relationship to device: definite, probably, possible, unlikely, etc.
Relationship of event to implantation procedure or operation: definite, probably, possible, 
unlikely, etc.
Severity of the event: mild, moderate, severe, vision-threatening, life-threatening, etc.
Subsequent treatments or interventions required: none, medical therapy, surgical or 
procedural intervention, hospitalization, etc.
Resolution status: resolved without sequelae, resolved with chronic sequelae, ongoing without 
sequelae, ongoing with sequelae, etc.
18.5  Sponsor (organization/institution/company):
N/A
If applicable, provide sponsor contact information:
19.0
 
Research Registration Requirements
19.1  ClinicalTrials.gov Registration:
Registration is not required 
Registration pending 
Registration complete 
“NCT” number:
NCT04436198
19.2  Defense Technical Information Center Registration (Optional):
Registration is not required 
Registration pending 
Registration complete 
20.0
 
References and Glossary
20.1  References:
Novis C. Astigmatism and toric intraocular lenses. 
 2000 Feb;11(1):
Curr Opin Ophthalmol.
47-50.
Shimizu K1, 
, 
 Toric intraocular lenses: correcting astigmatism while 
Misawa A Suzuki Y
controlling axis shift. 
 1994 Sep;20(5):523-6.
J Cataract Refract Surg.
Holland E1, 
, 
, 
, 
, 
. The AcrySof Toric 
Lane S Horn JD Ernest P Arleo R Miller KM
intraocular lens in subjects with cataracts and corneal astigmatism: a randomized, 
subject-masked, parallel-group, 1-year study. 
 2010 Nov;117(11):2104-
Ophthalmology.
11. doi: 10.1016/j.ophtha.2010.07.033. Epub 2010 Sep 16.
Felipe A, 
, 
, 
, 
. Residual 
Artigas JM Díez-Ajenjo A García-Domene C Alcocer P
astigmatism produced by toric intraocular lens rotation. 
 2011 
J Cataract Refract Surg.
Oct;37(10):1895-901. doi: 10.1016/j.jcrs.2011.04.036. Epub 2011 Aug 23
Rastogi A, Khanam S, Goel Y; Kamlesh, 
, 
. Comparative evaluation of 
Thacker P Kumar P
rotational stability and visual outcome of toric intraocular lenses with and without a 
capsular tension ring. 
 2018 Mar;66(3):411-415. doi: 10.4103/ijo.
Indian J Ophthalmol.
IJO_875_17.

6.  
7.  
8.  
9.  
10.  
11.  
Shah GD, 
, Vasavada AR, Vasavada VA, Rampal G, Shastry LR. Rotational 
Praveen MR
stability of a toric intraocular lens: influence of axial length and alignment in the capsular 
bag. 
 2012 Jan;38(1):54-9. doi: 10.1016/j.jcrs.2011.08.028. 
J Cataract Refract Surg.
Epub 2011 Nov 4.
Zhao Y, Li J, Yang K, Li X, Zhu S. Combined special capsular tension ring and toric IOL 
implantation for management of astigmatism and high axial myopia with 
cataracts? Semin Ophthalmol. 2016:1–6. doi: 10.1080/08820538.2016.1247181. 
[PubMed: 28005433]
Safran SG. Use of Capsular Tension Ring to Prevent Early Post-operative Rotation of a 
Toric Intraocular Lens in High Axial Myopia. JCRS Online Case reports.2015. [Last 
accessed on 2015 Aug 02]. Available from: http://www.dx.doi.org/10.1016/j.jcro. 
2015.02.001.
Sagiv O, Sachs D. Rotation stability of a toric intraocular lens with a second capsular 
tension ring. J Cataract Refract Surg. 2015;41:1098–9. [PubMed: 25937341]
Potvin R, Kramer B, Hardten D, Berdahl J. Toric intraocular lens orientation and residual 
refractive agtigmatism: an analysis. Clinical Opthalmology. 20 September 2016.
. 
, 
, 
, 
, 
. Comparison of clinical outcomes of 
Jung NY Lim DH Hwang SS Hyun J Chung TY
toric intraocular lens, Precizon vs Tecnis: a single center randomized controlled trial. BMC 
 2018 Nov 9;18(1):292. doi: 10.1186/s12886-018-0955-3.
Ophthalmol.
See Data Analysis Section 4 for Remaining References
12. Faul F, Erdfelder E, Lang A-G, Buchner A. G*Power 3: A flexible statistical power analysis 
program for the social, behavioral, and biomedical sciences. Behavior Research Methods. 2007; 
39 (2): 175-191.
13. R Core Team. R: A language and environment for statistical computing. R Foundation for 
Statistical Computing, Vienna, Austria. 2016 URL http://www.R-project.org/.
20.2  Abbreviations and Acronyms: