Custom Anterior Surfacing of Scleral Lens for Vision Quality Improvement in Patients With Keratoconus
Phase: NA
Conditions: Keratoconus
Sponsor: University of Rochester

FLAUM EYE INSTITUTE
Department of Ophthalmology
August 21, 2018                                                      Page 1 of 12
Custom Anterior Surfacing of Scleral Lens for Vision Quality 
Improvement in Patients with Keratoconus
Principal Investigator: Tara Vaz, OD
I. PURPOSE OF THE STUDY AND BACKGROUND 
1. Purpose of the study
The goal of the study is to examine the effects of custom front-surface wavefront correction 
on visual performance, and on neutralization of higher order aberrations, in patients wearing a 
scleral lens device. We will study patients with keratoconus, the most common type of corneal 
ectasia, who have already been fitted with the BostonSight BSS (Boston Sight Scleral) for 
improved visual function.
2. Background
Despite the increasing pace of innovation in vision care, there are many vision ailments, 
which do not yet have effective therapies. These eye conditions can result in moderate to 
severe vision impairment or blindness, which have severe impacts on an individual’s quality 
of life. One such condition is corneal ectasia which is characterized by a progressive thinning 
of the cornea causing a distortion in its shape and consequential visual impairment1. Many 
specific conditions fall within this category include keratoconus, keratoglobus, pellucid 
marginal degeneration2, Terrien’s marginal degeneration, and post-operative complications 
related to LASIK, RK, PRK, or corneal transplantation3.
Distortions of the cornea from these corneal ectasias can result in increased levels of higher 
order aberrations4, 5. Higher order aberrations are types of optical defocus that cannot be 
corrected by conventional spherical and astigmatic spectacle correction. This makes standard 
spectacle and contact lens vision correction inadequate for all but mild corneal ectasias. More 
advanced corrections such as scleral lenses can help mask higher order aberration content 
using a fluid reservoir, but some higher order aberrations can remain uncorrected and 
contribute to the degradation of visual performance6. These remaining aberrations following 
correction are termed residual aberrations. Interest in corneal aberrations has increased with 
the development of customized contact lenses7 and customized corrective refractive surgery8, 
9. 
The goal of these treatment options is to improve visual performance beyond the results 
gained by only correcting lower order aberrations, namely the spherical and cylindrical 
refractive errors. These customized techniques require the reliable determination of both 
overall higher order corneal aberrations and specific higher order aberration terms. 

FLAUM EYE INSTITUTE
Department of Ophthalmology
August 21, 2018                                                      Page 2 of 12
Measurement of residual higher order aberrations after correction of lower order aberrations 
with a scleral lens is a necessary step towards aberration correction and visual performance 
improvement. The amount of aberration present in an eye can be quantified using a wavefront 
analyzer. This method allows for quick, noninvasive, objective assessment of the quality of 
the optics of the eye10.
Several previous studies have been conducted to study and correct the effects of residual 
aberration with scleral lenses. Rigid gas permeable corneal contact lenses with aspheric optics 
offer improved visual acuity.  Studies, including one from this center, have found that 
aspheric front surface contact lenses improved visual acuity when compared to conventional 
spherical contact lenses.11, 12, 13 Earlier work at Boston Sight, Flaum Eye Institute, and 
elsewhere, has established that it is possible to reduce higher-order aberrations in patients 
wearing a scleral lens device with custom wavefront correction; in this early work, visual 
performance did not achieve levels typical of the normal population.14, 15 This study is 
designed to allow for further refinement of customized correction for patients with aberrated 
optical systems. 
The current study is another collaboration between Flaum Eye Institute and Boston Sight 
with the addition of Ovitz Corporation. The goal of the study is to examine the effects of 
custom front-surface wavefront correction on visual performance, and on neutralization of 
higher order aberrations, in patients wearing a scleral lens device. Ovitz manufactures an 
FDA-registered wavefront sensing device capable of measuring the residual higher order 
aberrations being studied. BostonSight provides the capability of manufacturing the standard 
and Higher Order Aberration (HOA)-customized scleral lenses being studied. The study will 
use the BostonSight Scleral (BSS) lens which is similar to the PROSE device used in previous 
collaborative studies. The BSS lens is FDA-cleared and provides a commercial solution with a 
standardized fitting process. 
II. CHARACTERISTICS OF THE RESEARCH POPULATION 
1. Number of subjects
Up to 40 subjects may be enrolled in the study. This number has been chosen based on the limited 
number of patients that fulfill the eligibility for participation.
2. Gender of Subjects
Inclusion in the study will not be gender specific and will not necessarily be equally men and 
women.
3. Age of Subjects
The subjects must be 18 or older to participate in this study.

FLAUM EYE INSTITUTE
Department of Ophthalmology
August 21, 2018                                                      Page 3 of 12
4. Racial and Ethnic Origin 
Subjects will not be selected based on racial or ethnic origin. 
5. Inclusion Criteria
A person will be included in the study if he/she:
Is 18 years or older and has full legal capacity to volunteer.
Has been diagnosed with Keratoconus;
Has no other active ocular disease;
Is currently wearing the BostonSight BSS in at least one eye;
Has non-spherical BostonSight BSS haptic design in the study eye;
Has 20/400 or better best corrected visual acuity with pinhole 20/60 or better in the 
study eye;
Is not pregnant or nursing;
Has voluntarily agreed to participate in the study by signing the statement of informed 
consent;
6. Exclusion Criteria
A person will be excluded from the study if he/she:

Is under the age of 18;

Has best corrected visual acuity outside 20/400;

Pregnant or nursing at the time of enrollment in the study;
7. Vulnerable Subjects
There are no vulnerable subjects for this study. All subjects will be notified that their 
participation is voluntary and that they are free to withdraw from the study at any time.
III. METHODS AND PROCEDURES 
1.  Overview
This study will be a single center, double-masked collection of data taking place at the 
Flaum Eye Institute. Informed consent will be obtained from all subjects after a thorough 
explanation of the nature and possible risks of the study. Flaum Eye Institute electronic health 
records of existing patients will first be screened by an optometrist or ophthalmologist to 
verify that they do not fall under the exclusion criteria. Some study communication regarding 
scheduling will be done over the phone or email. The screening will be similar to a standard 

FLAUM EYE INSTITUTE
Department of Ophthalmology
August 21, 2018                                                      Page 4 of 12
eye exam (without eye dilation) and will include a slit lamp examination as well as visual 
acuity and basic vision evaluation.
The study eye will be chosen based on inclusion criteria; if both eyes qualify, the eye with 
worse best corrected acuity will be chosen. A new scleral lens that incorporates peripheral 
etched markings is needed for the second visit. These markings are used to determine the 
exact rotational and positional orientation of the lens on the eye when performing the HOA 
measurement in the second visit. If screening evaluation reveals that the current lens does not 
fully neutralize spherical refractive error or that the current lens is not positionally stable, a 
design of this new lens will be updated to these new optimized parameters. If no optimization 
is required, then an identical lens will be created with the orientation markings added. The 
subject will keep his or her original lens and wear it between study visits until the end of the 
study. The new scleral lenses that will be made for each subject will be kept at the Flaum Eye 
Institute between subject visits. The principle investigator along with the study team will be 
responsible for storage, dispensing, collection, accountability and disposal. BostonSight will 
be responsible for the creation of the lenses.
At the second visit, the patient’s vision and fit will be evaluated with the optimized 
baseline BSS lens. Visual acuity and device fit will be evaluated and recorded. If the BSS 
device fit is still not optimized, then a new device will be made, and the second visit 
evaluation will be rescheduled. Once the baseline lens design is determined to be satisfactory, 
the patient will have their wavefront aberration measured with a wavefront sensor. We will 
dilate the pupil pharmacologically with phenylephrine (2.5%) and tropicamide (1%) and take 
wavefront measurements of the optical aberrations of the subject’s eye wearing the baseline 
lens using a portable, non-invasive wavefront analyzer designed to measure highly aberrated 
eyes (Ovitz, P10/EyeProfiler). We will then design and manufacture a study lens that is 
identical in design to the baseline BostonSight BSS lens except for a custom front surface 
designed to neutralize the optical aberrations measured with the wavefront analyzer. This 
HOA-optimized lens will be created prior to the third visit.
At the third visit the patient’s vision and fit will be evaluated with the new HOA-optimized 
lens. A designated study team member will measure visual acuity and over-refraction of the 
patient. If an adjustment is needed for the lens, then a new device will be made, and the third 
visit evaluation will be rescheduled.
Once well-fitting baseline and HOA-optimized test lenses are established, both lenses will 
be remade and presented to the designated study team member in charge of evaluation and 
subject together in a masked fashion. During a fourth visit, the patient’s vision will be 
extensively evaluated using standard non-invasive optometric measurements with each of the 
two lenses. First the patient’s will undergo a basic evaluation with each lens to ensure that the 
fit is correct. The patient will then undergo basic visual acuity; high and low contrast visual 
acuity, contrast sensitivity, and subjective vision scoring with each lens. The subject’s 
wavefront aberration will also be measured again with each lens.

FLAUM EYE INSTITUTE
Department of Ophthalmology
August 21, 2018                                                      Page 5 of 12
The wide variety of visual assessments have been chosen to properly evaluate keratoconic 
eyes with heavy high order aberration presence. The inadequacy of high contrast visual acuity 
measurements as an index of visual quality has been previously discussed16. Therefore, 
studies have investigated other measures of vision in keratoconus, such as contrast sensitivity 
measurements17-19. It has been revealed that the loss of contrast sensitivity in keratoconus 
cannot be predicted from standard visual acuity measurements17, 20, 21. 
The relationship between contrast sensitivity, visual performance and aberrations has been 
researched. One study reported that while coma aberrations were correlated with letter 
contrast sensitivity, spherical aberrations were not.22 Another study reported that following 
LASIK, the induced changes in contrast sensitivity were associated with changes in total 
higher-order and spherical aberrations and that the changes in low-contrast visual acuity 
resulting from surgery were correlated with the changes in total higher-order, coma, and 
spherical aberrations23. Due to these considerations, a wide mix of different vision evaluations 
was included in the study to better understand the differences between the test and control 
lens.
As noted in each description, study visits may be repeated if the lens being tested at that 
visit is found to have a suboptimal fit. Visits that find suboptimal fitting lenses will take 30 
minutes or less. Each visit can be rescheduled a maximum of 3 times. The highest number of 
visits a patient can undergo is 10. Patients that require more than this number will be removed 
from the study as BostonSight is only willing to provide up to 10 lenses free of charge per 
subject; however, their collected data may be maintained with their continued consent.

FLAUM EYE INSTITUTE
Department of Ophthalmology
August 21, 2018                                                      Page 6 of 12
Table listing all procedures that will be completed and the expected duration of each visit.
Visit 1:Screening
Visit 2: 
Study Visit 1
Visit 3:
Study Visit 2
Visit 4:
Study Visit 3
Visit Duration
30-60 
min
60-120 min
30 
min
120-180 min
Visit Description
Screening and current 
BSS fit evaluation. A 
lens will be 
manufactured 
following the visit.
The new baseline lens 
is evaluated. If the fit 
is suboptimal another 
lens will be made and 
visit 2 rescheduled.  
Once the baseline fit is 
optimized then a 
wavefront 
measurement is done.
The HOA-
optimized lens is 
given to the subject. 
If the fit is 
suboptimal another 
lens will be made 
and visit 3 
rescheduled. 
Baseline and HOA-
optimized lenses are 
made anew. 
If the fit is 
suboptimal another 
lens will be made 
and visit 4 
rescheduled. 
Consent Process
X
Demographic Information 
Questionnaire
X
Slit Lamp Exam for Lens Fit
X
X
X
X
Visual Acuity and Basic Vision 
Evaluation
X
X
X
X
Wavefront Sensor HOA 
Measurement
X
X
Pharmacological Dilation
X
X
Extended Vision Evaluation 
(High and Low Contrast VA; 
Contrast Sensitivity)
X
Subjective Preference Evaluation
X
2.    Instruments
Portable Wavefront Sensor (P10/EyeProfiler) - Subjects will be sitting or standing in front of 
the trained member of the study team. The member of the study team will hold the Wavefront 
Sensor up to the subject’s eye where the orbit of the eye will make contact with a soft rubber 
eyecup. The subject will be asked to look forward at chart across the room and blink naturally 
while keeping the dim red spot (laser) “as clear as possible” throughout the measurement. The 
light reflected back out of the subjects’ eye is collected to obtain measurements of wavefront 
aberrations of the eye. The measurement and light exposure will take an average of 6 seconds 
with a maximum of 15 seconds.

FLAUM EYE INSTITUTE
Department of Ophthalmology
August 21, 2018                                                      Page 7 of 12
3.   Study Timeline:
   Each subject will undergo 4-6 study sessions taking 4-7 ½ hours. However, some subjects 
may require up to 9 ½ hours if unexpected refitting and repeated visits are required. A subject 
will not have more than 10 visits.
4.  Data Analysis and Monitoring
      Data from each of the subjects will be analyzed individually. 
Statistical analyses will be performed using conventional software package such as SPSS. 
At the end of each study visit, a team member will verify that the data obtained is readable 
and of sufficient quality for analysis. If the data is not usable, the subject may be asked to 
repeat the study on the same day or return on another day.
5.   Data Storage and Confidentiality
After individuals are consented and enrolled in the study, they will be assigned a de-identified 
number. The file containing their personal health information (PHI) will reside on a limited-
access shared drive with firewall and password protection and is restricted to individuals in 
the research team named on this application. The measurement data is transported on portable 
hard drives and analyzed on an encrypted, password-protected computer in the secured lab 
area. This data will be stored on desktops and portable hard drives that remain in offices in the 
limited access research area and are used for analysis on password-protected personal 
computers by members of the research team. Despite these measures, there is always some 
risk that patient information is unintentionally disclosed.
Screening exam results, ethnicity/race form and other printed PHI will be maintained in a 
locked office in the limited-access research area.
Identifiable PHI will be shared with BostonSight for the purposes of manufacturing the scleral 
lenses throughout the study. This will use the same Fit Connect secure computer system that 
is already used by Flaum Eye Institute and BostonSight for ordering Boston Sight Scleral 
lenses prescribed to regular patients. Data shared through this system is limited to name, date 
of birth, and lens parameters.
De-identified study information will be shared with Ovitz Corporation for the purposes of 
scientific analysis.
IV. RISK/BENEFIT ASSESSMENT 
1. Risk Category
Minimal risk is involved. 

FLAUM EYE INSTITUTE
Department of Ophthalmology
August 21, 2018                                                      Page 8 of 12
2. Potential Risk
When taking measurements, the subject’s eyes will be exposed to light or light flashes that are 
about the same or lesser intensity than those in a routine eye exam in an ophthalmologist’s 
office. Subjects may get tired from having measurements taken in their eyes.

For wavefront sensor measurement, subjects will require the use of eye drops that 
dilate the pupil. The eye drops we will use, Phenylephrine 2.5% and Tropicamide 1%, 
are routinely prescribed by ophthalmologists. The dilation drop may cause mild 
discomfort, stinging, and temporary redness in the eye. Exposure to light may be 
uncomfortable and vision may be blurred while the eye remains dilated for at least 5-7 
hours. Before the use of eye drops subjects will receive a screening exam in order to 
make sure that their eyes are not at risk for closed-angle glaucoma. Subjects recruited 
from the Flaum Eye Institute practices will already have been evaluated for closed-
angle glaucoma risk and therefore this step of recruitment may be waived. A small 
proportion of the population can develop an allergic conjunctivitis in response to 
topically applied eye drops.  This is a benign condition that is self-limited upon 
discontinuing the drops and will either spontaneously resolve in one to three days 
without treatment or can be treated with mild anti-inflammatory medications if 
needed. If the eye drops are contaminated, however, they could cause an infection, 
which could be treated with mild anti-inflammatory or antibiotic eye drop medication, 
or the subject may be referred for additional medical care. Study staff will administer 
the eye drops. The drops are instilled in the lower portion of the eye, and dilation 
occurs in approximately 20 minutes.
The effects of the eye drops used in this experiment have not been studied on pregnant 
women or fetuses; therefore pregnant women will be excluded from this study. 

For wavefront sensor measurement, the intensity of the laser diode is eye-safe 
according to the maximal permissible exposures allowed by the ANSI Standards. The 
light source will emit between 800-850nm of light. In this wavelength range, the eye 
can tolerate constant exposure of up to 400µW. The laser diode will operate at up to 
25µW output, which is more than 15 times less than the maximal permissible 
exposure. All light sources used in this study are less than the Maximum Permissible 
Exposure (MPE) specified by the American National Standard for the Safe use of 
Lasers (ANSI Z136.1-2000)].

Subjects in this study will already be wearers of BostonSight Scleral lenses and will 
have already been made aware of and exposed to the risks of their use. These risks 
can include but are not limited to discomfort, pain, tearing, redness, burning, 
sensitivity to light, and blurred vision when initially wearing the lenses. There is 
also a small chance of infection and corneal abrasion from normal usage. 

FLAUM EYE INSTITUTE
Department of Ophthalmology
August 21, 2018                                                      Page 9 of 12
Participation in this study requires subjects to undergo a new fitting process which 
carries an increased risk of corneal abrasion beyond normal use. This is because the 
lenses are applied and removed more frequently during the fitting process. Serious 
adverse events or infections attributable to the scleral lens device are rare.24-28 
Patients will be evaluated at every screening and study visit to ensure that all lenses 
being tested on the eye fit properly and are not causing corneal abrasions or other 
discomfort. Even when an identical lens is manufactured to one previously fit on the 
same patient, the lens fit will be re-evaluated. If any of the discussed complications 
arise an on-site Flaum Eye Institute optometrist will provide treatment.
3. Protection Against Risks
Care will be taken such that all screening and measurement procedures will be performed in a 
fashion consistent with best clinical practice. All potential risks of the study will be minimized 
as best as possible. A study team member will remain with the subject for the screening and 
measurement visits to allow the team to identify and appropriately manage any unexpected 
developments. 
An optometrist will either monitor the subject or be available when the subject is at the study 
site. Subjects will be provided with a phone number for the study team available for 24 hours. 
In the unlikely circumstance that a subject has an issue after leaving the study site, he or she 
can contact the study team. The subject will be managed appropriately by an attending 
ophthalmologist at the University of Rochester Flaum Eye Institute.
The research team will bring adverse events, unanticipated problems or other study-related 
safety information, and protocol deviations and amendments to the Principle Investigator’s 
attention as they occur during the study. The Principle Investigator will bring all of these 
issues and changes to the attention of the RSRB with amendments submitted appropriately as 
they arise.
4. Potential Benefits to the Subjects
 If the patient prefers the optimized test lens created during the trial, then they will be 
provided with is lens free of charge. There are no other benefits from being in this study.
5. Alternatives to Participation
Participation is entirely voluntary. The subject may choose to not participate at any time.

FLAUM EYE INSTITUTE
Department of Ophthalmology
August 21, 2018                                                      Page 10 of 12
V. SUBJECT IDENTIFICATION, RECRUITMENT AND CONSENT/ASSENT 
1. Method of Subject Identification and Recruitment
Subjects will be recruited through their medical records and will either be approached by their 
optometrist  at their next regularly scheduled appointment or by a designated study team 
member over the phone. The study will be explained in detail to the potential subject and any 
questions that the subject may have about the study will be answered. Patients may also be 
recruited when they come to their optometrist for their eye exam checkup without prior 
review of their records. If the subjects express interest in the study, they will be put in contact 
with the member of the study team who will then answer further questions or set up a 
screening visit for the potential subject.
2. Process of Consent
Prior to enrollment subjects will have ample time to review the consent form, and any 
questions or concerns will be addressed. Prior to the first study session, the designated study 
team member obtaining consent will explain the procedures for the visit in detail and address 
any additional questions. Details of each study session will be explained greater detail before 
subjects start interventions. The participant will be explicitly told that he/she may stop 
participation at any time. Written consent will be obtained on the appropriate RSRB-stamped 
consent forms. The subject will be offered a copy of the signed consent form.
3. Subject Capacity
Only subjects with the capacity to give informed consent will be recruited into this study.  
4. Consent Forms
The Principle Investigator, together with the team members, is responsible for ensuring that 
valid consent is obtained and documented for all subjects on the stamped consent form prior 
to start of study procedures. 
5. Documentation of Consent
The subject signs the consent and a copy is offered to the subject. The original consent form 
will be housed in an office file cabinet in a locked office of the limited access research area. 
6. Costs to the Subject
The subject will incur no costs a result of participating in the study. 
7. Payment for Participation
Study patients will not be compensated for their participation in the study. 

FLAUM EYE INSTITUTE
Department of Ophthalmology
August 21, 2018                                                      Page 11 of 12
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FLAUM EYE INSTITUTE
Department of Ophthalmology
August 21, 2018                                                      Page 12 of 12
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