Initial Correction Keratoconus: Scleral vs Corneal Gas Permeable Lenses SCOPE Study
Phase: NA
Conditions: Keratoconus
Sponsor: University of Illinois at Chicago

 
 
 
 
Initial Correction Keratoconus: Scleral vs Corneal Gas Permeable Lenses  
Principal Investigator: 
Ellen Shorter, OD 
Illinois Eye and Ear Infirmary 
Department of Ophthalmology and Visual Sciences 
University of Illinois at Chicago 
Chicago, IL 60612 
eshorter@uic.edu 
312-996-5410 
 
Co-Investigators: 
Joe Baker, MPH 
Department of Ophthalmology & Visual Sciences 
1855 W. Taylor St., Room 2186C, M/C 648 
Chicago, IL 60612 
jbaker7@uic.edu 
 
Dingcai Cao, PhD 
University of Illinois at Chicago Department of Ophthalmology and Visual Sciences 
1905 W Taylor Street 
Chicago, IL 60612 USA 
dcao98@uic.edu 
 
 

Initial correction keratoconus: corneal gas permeable vs scleral lens 
 
Version 6 
Page 2 of 23 
04/28/2022 
Bhavana Kolli, MHA 
Department of Ophthalmology & Visual Sciences 
1855 W. Taylor St. Room 2186C, M/C 648,  
Chicago, IL 60612 
bkolli2@uic.edu 
 
Angelica Scanzera, OD, MPH 
Illinois Eye and Ear Infirmary & Millennium Park Eye Center  
Department of Ophthalmology and Visual Sciences 
1855 W. Taylor St. & 30 N Michigan Ave, Suite 410 
University of Illinois at Chicago 
Chicago, IL 60612 & 60602 
ascanz@uic.edu 
312-996-5410 
 
Hannah Yoon, OD, MS 
Illinois Eye and Ear Infirmary 
Department of Ophthalmology and Visual Sciences 
University of Illinois at Chicago 
Chicago, IL 60612 
yoonh@uic.edu 
312-996-5410 
 
 
 

Initial correction keratoconus: corneal gas permeable vs scleral lens 
 
Version 6 
Page 3 of 23 
04/28/2022 
Jennifer Fogt, OD, MS 
Ohio State University College of Optometry 
1665 Neil Ave.   
Columbus, OH 43210 USA 
fogt.78@osu.edu 
 
Jennifer Harthan, OD 
Illinois College of Optometry 
3241 S. Michigan Ave 
Chicago, IL 60616 USA 
JHarthan@ico.edu 
 
Muriel Schornack, OD 
Mayo Clinic 
200 1st St SW 
Rochester, MN 55905 USA 
Schornack.Muriel@mayo.edu 
 
Cherie Nau  
Mayo Clinic 
200 1st St SW 
Rochester, MN 55905 USA 
Nau.Cherie@mayo.edu 
 
 

Initial correction keratoconus: corneal gas permeable vs scleral lens 
 
Version 6 
Page 4 of 23 
04/28/2022 
Study Locations: 
Illinois Eye and Ear Infirmary Contact Lens Service (UIC) 
Department of Ophthalmology and Visual Sciences 
University of Illinois at Chicago 
Chicago, IL 60612 
 
Illinois Eye Institute Cornea and Contact Lens Service  
3241 S. Michigan Ave 
Chicago, IL 60616 USA 
 
Millennium Park Eye Center (UIC)  
30 N Michigan Ave 
Suite 410 
Chicago, IL 60602 
 
Ohio State University College of Optometry 
338 W. 10th Avenue  
Columbus, OH 43210 USA 
 
Mayo Clinic 
200 1st St SW 
Rochester, MN 55905 USA 
 
 
 

Initial correction keratoconus: corneal gas permeable vs scleral lens 
 
Version 6 
Page 5 of 23 
04/28/2022 
Version: 6 
Date: 04/28/2022 
TABLE OF CONTENTS 
Page 
Table of Contents ............................................................................................................ 5 
List of Abbreviations ........................................................................................................ 6 
1.0 Project Summary/Abstract ................................................................................... 7 
2.0 Background/Scientific Rationale ......................................................................... 8 
3.0 Objectives/Aims .................................................................................................... 9 
4.0 Eligibility .............................................................................................................. 10 
4.1 Inclusion Criteria ........................................................................................... 10 
4.2 Exclusion Criteria .......................................................................................... 11 
4.3 Excluded or Vulnerable Populations ........................................................... 11 
5.0 Subject Enrollment.............................................................................................. 11 
6.0 Study Design and Procedures ........................................................................... 12 
7.0 Expected Risks/Benefits ..................................................................................... 15 
8.0 Data Collection and Management Procedures ................................................. 15 
9.0 Data Analysis ....................................................................................................... 15 
10.0 Quality Control and Quality Assurance ............................................................. 15 
11.0 Data and Safety Monitoring ................................................................................ 16 
12.0 Statistical Considerations .................................................................................. 16 
13.0 Regulatory Requirements ................................................................................... 16 
13.1 
Informed Consent ..................................................................................... 16 
13.2 
Subject Confidentiality ............................................................................. 16 
13.3 
Unanticipated Problems .......................................................................... 17 
Appendices ................................................................................................................... 19 
 

Initial correction keratoconus: corneal gas permeable vs scleral lens 
 
Version 6 
Page 6 of 23 
04/28/2022 
LIST OF ABBREVIATIONS  
 
 
COI 
 
 
Conflict of Interest 
DHHS  
 
Department of Health and Human Services 
DMC  
 
Data Monitoring Committee 
DSMB  
 
Data and Safety Monitoring Board 
DSMP  
 
Data and Safety Monitoring Plan 
FERPA 
 
Family Educational Rights and Privacy Act 
FDA  
 
Food and Drug Administration 
GCP  
 
Good Clinical Practice 
HIPAA 
 
Health Insurance Portability and Accountability Act 
IBC 
 
 
Institutional Biosafety Committee 
ICD 
 
 
Informed Consent Document 
ICH 
 
 
International Conference of Harmonization 
IDE 
 
 
Investigational Device Exemption 
IDS 
 
 
Investigational Drug Service 
IND 
 
 
Investigational New Drug  
IRB 
 
 
Institutional Review Board 
LAR  
 
Legally Authorized Representative 
OHRP  
 
Office of Human Research Protections 
OPRS  
 
Office for the Protection of Research Subjects 
PHI 
 
 
Protected Health Information 
PI 
 
 
Principal Investigator 
PPRA  
 
Protection of Pupil Rights Amendment 
QA/QI  
 
Quality Assurance/Quality Improvement 
SAE  
 
Serious Adverse Event 
SOP  
 
Standard Operating Procedure 
 
 

Initial correction keratoconus: corneal gas permeable vs scleral lens 
 
Version 6 
Page 7 of 23 
04/28/2022 
1.0 
Project Summary/Abstract 
 This is a multi-center, randomized interventional clinical trial with a 2x2 
crossover design of patients with keratoconus fit with corneal and scleral gas 
permeable contact lenses.   
 While both corneal gas permeable and scleral lenses have been show to 
improve visual acuity in individuals with keratoconus, it has yet to be 
determined if one option has superior comfort and overall patient satisfaction 
in patients new to gas permeable lens use.   

Initial correction keratoconus: corneal gas permeable vs scleral lens 
 
Version 6 
Page 8 of 23 
04/28/2022 
2.0 
Background/Scientific Rationale  
 
Keratoconus is a non-inflammatory, progressive disease in which corneal 
irregularity increases and thickness decreases.  It is thought to occur in 
approximately 1 of 2,000 individuals1 and has been associated with contact lens 
wear, eye rubbing, Down’s syndrome, atopic disease, connective tissue disease, 
and family history of corneal ectatic disease.2  As the condition develops, 
progressively more advanced forms of optical correction are needed to provide 
functional visual acuity for patients.  Until recently, corneal rigid gas permeable 
lenses were considered the primary mode of correction for patients with 
keratoconus.  Now, however, practitioners have multiple options for reducing the 
optical aberrations caused by keratoconus, including custom hydrogels, hybrid 
lenses, and scleral lenses.  As a consequence patients who previously could not 
be fit with lenses are able to wear them, decreasing the need for surgical 
intervention such as keratoplasty.   However, being able to use non-surgical 
strategies for keratoconus management may lead to an increased number of 
visits and complexity of decision-making during the contact lens fitting process.  
As of yet, no single option for optical correction has been identified as the 
preferred mode of correction in terms of overall patient satisfaction with vision, 
comfort, and ease of use.  The order in which various forms of optical correction 
would be most logically introduced has yet to be determined. 
 
 
Keratoconus is known to impact overall quality of life, as well as vision-related 
quality of life.3-5  We hypothesize that patient-reported quality of life may vary 
depending upon the prescribed form of contact lens correction.  Most studies, 
which investigate quality of life, are relatively small, and assess change in quality 
of life following a specific intervention.  
 
 
In this study, patients will be prospectively fit with both corneal gas permeable 
and scleral lenses according to standard clinical practice.    Both corneal gas 
permeable and scleral lenses are considered standard of care for patients with 
keratoconus.  In a previous study by Kumar et al, patients with keratoconus who 
were naiive to contact lens wear reported comparable improvement in visual 
function (including logMAR acuity, contrast sensitivity function, steroacuity using 
Howard-Dolman apparatus and higher-order wavefront abberations) for both 
corneal gas permeable and scleral lenses.6  The authors suggest that non-visual 
factors such as quality of lens fitting, wearing comfort and cost may be more 
important for determining lens preference among patients than visual 
performance.  Corneal gas permeable lenses were more difficulty to fit, and were 
not as comfortable, but were less expensive than scleral lenses.6 
 
An additional study evaluated subjective comfort between corneal gas permeable 
and scleral lenses in patients with keratoconus who were stable corneal gas 
permeable lens users .7  Subjective comfort scores were significantly higher in 

Initial correction keratoconus: corneal gas permeable vs scleral lens 
 
Version 6 
Page 9 of 23 
04/28/2022 
scleral lens wearers, however the final lens of choice in the study were similar 
with 53% opting to continue with their habitual corneal gas permeable lens and 
47% choosing the scleral lens instead.7 Similar to the study by Kumar et al., 
there was no significant difference in best corrected visual acuity or contrast 
sensitivity function between the two lens modalities.7  
 
 
3.0 
Objectives/Aims 
 
Specific Aim; 
 
This study will prospectively compare visual satisfaction and ease of use 
between corneal gas permeable and scleral lenses for patients with mild to 
moderate keratoconus who are naiive to lens use.   
 
 
Hypotheses to be tested: 
1. Participants will select scleral lens over corneal gas permeable lens as their 
preferred final lens type.  Scleral lens comfort will be rated higher than corneal 
gas permeable lenses.  
 
 
Primary Outcome Measure: 
 
1. The Primary outcome of this study is participant selected final lens choice for 
continued use for the management of keratoconus.   
 
 
Secondary Outcome Measures: 
 
 1. 
Best corrected Snellen visual acuity converted to logMAR  
 
2. 
Practitioner ease of lens fitting including number of visits, number of trial 
lens required for fitting and number of lenses ordered. 
 
3. 
Patient burden including time required to learn safe application and 
removal as well as daily time require for lens application and removal. 
 
4. 
Subjective comfort with lens use rated on comfort scale of 0 (not 
comfortable) to 10 (very comfortable) 
 
5. 
Dry eye symptoms assessed using the validated OSDI and CLDEQ do we 
get baseline meibography on each patient.  
 
6. 
Impact of lens cost on lens choice. 
 
Methods: 
 Patients will be consented and enrolled in the study during routine clinical 
visits.   
 At the first study visit, participants will be fit with corneal gas permeable and 
scleral lenses in both eyes. The OSDI and CLDEQ questionnaires will be 
assessed.  
 The patient will return for regularly scheduled fitting visits to maximize lens 
fitting and visual acuity.  
 At the 2nd study visit, patients will be randomized to receive lens application 
and removal training with lens type #1.  Patients will begin daily wear of lens 
type #1.     

Initial correction keratoconus: corneal gas permeable vs scleral lens 
 
Version 6 
Page 10 of 23 
04/28/2022 
 
At the 3rd study visit (2-4 weeks after dispensing of lens #1), visual acuity, ease of 
use and subjective comfort of lens #1 will be assessed. The OSDI and CLDEQ 
questionnaires will be repeated.   
 
 The participant will be trained in lens application and removal with lens #2.  Lens 
#1 will be returned to the study clinician unless the patient refuses (thus ending 
the study).   
 
At the 4th study visit (2-4 weeks after dispensing lens #2), visual acuity, ease of 
use and subjective comfort of lens #2 will be assessed.  The OSDI and CLDEQ 
questionnaires will be repeated. Participants will be asked to select their final lens 
of choice.  Participants unable to return for a study visit will be contacted to 
complete the surveys and final lens preference, 
 
4.0 
Eligibility 
 Potential participants will be identified and recruited from ophthalmology and 
optometry clinics at study sites during routine visits.   
 Individuals must have a diagnosis of keratoconus confirmed by clinical 
examination and topography. 
 Wiliness to return for a minimum of 4 study visits. 
 The principal and co-investigators will determine subject eligibility using study 
eligibility checklist.  
 
4.1 Inclusion Criteria 
 Age 18 or older. 
 Diagnosis of keratoconus. 
 Available baseline corneal topography and pachymetry. 
 Amsler-Krumeich keratoconus classification9 of stage 1 or higher 
 

Initial correction keratoconus: corneal gas permeable vs scleral lens 
 
Version 6 
Page 11 of 23 
04/28/2022 
 
 
 
 
4.2 Exclusion Criteria 
 No prior corneal transplantation or INTACTS. 
 No prior use of hybrid, corneal or scleral gas permeable lenses. 
 Presence of corneal scarring. 
 
4.3 Excluded or Vulnerable Populations 
 No vulnerable populations will be enrolled. 
 Non-English speaking subjects can be enrolled with the use of translation 
services.  
 
5.0 
Subject Enrollment 
 After identification, potential participants will be asked if they would like to 
hear more about the study during routine clinical visits. 
 A standardized recruitment script will be used by study investigators.   
 The informed consent document will be reviewed with potential participants.  
 Individuals with a diagnosis of keratoconus meeting all inclusion and 
exclusion criteria and willing to participate will be enrolled by the principle and 
co-investigators.     
 Participants will be compensated $40 (Visa gift cards) for each of the four 
study visits at the completion of the study. The patient will receive their final 
selected lens of choice at no cost. 
 
 
 

Initial correction keratoconus: corneal gas permeable vs scleral lens 
 
Version 6 
Page 12 of 23 
04/28/2022 
6.0 
Study Design and Procedures 
 Multi-center study sites will include: 
.1 
Illinois Eye and Ear Infirmary, Chicago IL.(UIC)  
.2 
Millennium Park Eye Center, Chicago, IL. (UIC) 
.3 
The Mayo Clinic, Rochester MN. 
.4 
The Ohio State University, Columbus OH.  
.5 
The Illinois College of Optometry, Chicago IL. 
 
 
 
 This is a prospective, multi-center, randomized interventional clinical trial with 
a 2x2 crossover design of patients with keratoconus fit with corneal and 
scleral gas permeable contact lenses.  The crossover design allows intra-
subject differences between two randomized groups with participants serving 
as their own controls. 
 This is a pilot study to determine sample size and feasibility of study protocol 
for a larger randomized study. 
 Each clinic will enroll up to 25 participants with a maximum of 125 
participants.  
 
 
Screening eligibility 
.1 
Patients age 18 or older with a diagnosis of keratoconus will be recruited 
during routine clinical exams at the Illinois Eye and Ear Infirmary.  
.2 
Available baseline corneal topography and pachymetry. 
.3 
Willingness to return for 4 study visits. 
 
Informed consent will be obtained by the principal investigator or co-investigators.   
 
 
Study visit number 1 (estimated 45-90 minutes) 
.1 
Patient demographics (age, race, age diagnosed with keratoconus) 
[standard of care] 
.2 
Past ocular and medical history including ocular procedures such as 
corneal collage crosslinking and corneal surgery. [standard of care] 
.3 
Best corrected visual acuity with manifest refraction [standard of care] 
.4 
Corneal curvature using topography [standard of care] 
.5 
Corneal pachymetry (thickness) [standard of care] 
.6 
Meibography [standard of care] ifalready performed and present in the 
patient’s medical record, the data will be gathered. However, it will not be 
completed solely for the purpose of this study. . 
.7 
Dry eye symptoms and contact lens comfort assessed using the validated 
12-item OSDI and CLDEQ questionnaire.  [for research purposes]  
.8 
 Research intervention: Fitting for keratoconus [standard of care] 
.8.1 
Both eyes will be fit according to standard practices with the RoseK 
2 corneal gas permeable and Synergeyes VS scleral lenses 
following manufacturer’s recommendations. 
 

Initial correction keratoconus: corneal gas permeable vs scleral lens 
 
Version 6 
Page 13 of 23 
04/28/2022 
.8.1.1 Over refraction and best corrected visual acuity.  
.8.1.2 Subjective comfort with lens use rated on comfort scale of 0 
(not comfortable) to 10 (very comfortable).  
 
 
Routine Follow up visits to evaluate lens fit and visual acuity according to 
standard practice until lenses are deemed adequate for dispensing. [standard of 
care]. 
 
 
Study visit number 2 (estimated 30-60 minutes) 
.1 
Randomize to dispense lens #1 vs lens #2. [for research purposes] 
.2 
Lens application and removal handling [standard of care]. 
.3 
Instructions on lens disinfection procedures. 
.4 
Best corrected visual acuity with lens #1 [standard of care] 
.5 
Subjective comfort with lens use rated on comfort scale of 0 (not 
comfortable) to 10 (very comfortable) [for research purposes]. 
 
 
Study visit number 3- wearing lens #1 between 2-4 weeks for minimum of 3 
hours (estimated 45-75 minutes) 
.1 
Best corrected visual acuity with lens #1 [standard of care] 
.2 
Hours of lens wear today, average hours of lens wear time, days per week 
of per week and daily time spent on lens application and removal (general 
question – patients will not need to keep track or a log) [standard of care] 
.3 
Subjective comfort with lens use rated on comfort scale of 0 (not 
comfortable) to 10 (very comfortable) [for research purposes]. 
.4 
Dry eye symptoms assessed (OSDI questionnaire), contact lens comfort 
assessed (CLDEQ).  [for research purposes] 
.5 
Lens #2 application and removal training [for research purposes].  
.6 
Best corrected visual acuity with lens #2 [standard of care]. 
.7 
Subjective comfort with lens use rated on comfort scale of 0 (not 
comfortable) to 10 (very comfortable) [for research purposes]. 
 
Study visit number 4- wearing lens #2 between 2-4 weeks for minimum of 3 
hours (estimated 15-45 minutes)  
.1 
Best corrected visual acuity with lens #2 [standard of care] 
.2 
Hours of lens wear today, average hours of lens wear time, days per week 
of per week and daily time spent on lens application and removal (general 
question – patients will not need to keep track or a log) [standard of care] 
.3 
Subjective comfort with lens use rated on comfort scale of 0 (not 
comfortable) to 10 (very comfortable) [for research purposes]. 
.4 
Dry eye symptoms assessed (OSDI questionnaire), contact lens comfort 
assessed (CLDEQ).  [for research purposes] 

Initial correction keratoconus: corneal gas permeable vs scleral lens 
 
Version 6 
Page 14 of 23 
04/28/2022 
.5 
Participant final selection of lens of choice #1 or #2 [for research 
purposes]. 
.6 
Participant final selection of lens of choice #1 or #2 given average self-pay 
cost of annual replacement [for research purposes]. 
 
 
Final participant preferences- participants can be contacted to complete the 
surveys and final lens preference, 
.1 
Dry eye symptoms assessed (OSDI questionnaire), contact lens comfort 
assessed (CLDEQ).  [for research purposes] 
.2 
Participant final selection of lens of choice #1 or #2 [for research 
purposes]. 
.3 
Participant final selection of lens of choice #1 or #2 given average self-pay 
cost of annual replacement [for research purposes]. 
 
 
Unscheduled visits 
Will tally unscheduled visits and current lens type. [standard of care] 
 
For Studies that Collect Prospective Data 
 
 Data will be collected prospectively from the electronic medical record 
using paper care report forms and RedCAP by the primary and co-
investigators at all study sites.   
 A master list will be used to code participants and maintain study 
documents with study ID only. The list will be maintained by the 
investigator at each study site. De-identified data only will be shared with 
co-investigators listed on the study and with the locations listed on this 
study. The list will be stored in a locked cabinet of a locked office.  
 At the completion of the study, the lists will be destroyed. 
 De-identified data only will be maintained for future research use. 
 
 
 
Survey studies  
 Participants will complete the validated 12-item OSDI10 and the Contact 
lens dry eye questionnaire-8 (CLDEQ-8) 11 and comfort scale of contact 
lens performance to assess dry eye symptoms at each study visit.    
 The OSDI Score is assessed on a scale of 0 to 100 with higher scores 
representing greater disability.   
 
Studies involving use of product  
 
Two products will be used in this study. 
o 
Contact lens #1: SynergEyes VS (Synergeyes, Inc., Carlsbad CA) which 
features bi-tangential toric peripheries with linear landing zones. The 
standard lens is 16.0mm and is available from 14.5 to 17.5mm diameters.   
o 
Contact lens #2: RoseK2 corneal gas permeable lens (Blanchard 
Contact Lens, Inc. Manchester, NH). The lens is available in with a base 

Initial correction keratoconus: corneal gas permeable vs scleral lens 
 
Version 6 
Page 15 of 23 
04/28/2022 
curve range from 4.30 to 8.60 mm, diameter of 7.90 to 10.40mm. 
 ·      Product information including lens order number, lens parameters, lens 
materials and verification will be tracked and maintained in the case report form 
and on RedCAP.  
 ·       Adverse events will be recorded and immediately reported to the clinic PI. 
o 
Potential adverse events include corneal scratch or abrasion related to 
lens handling, blurred vision, red or irritated eyes, pain in and around the 
eyes and excessive tearing. 
 
7.0 
Expected Risks/Benefits 
 There are potential benefits for participants including improved visual clarity. 
Contact lens prescription is the current standard of care for keratoconus.  
There are associated risks associated with contact lens use including eye 
pain, epithelial defects, microbial keratitis, corneal scarring and 
neovascularization.  
 There are potential risks associated with new contact lens wear including 
handling issues and loss of contact lens.  This may result in eye pain, 
epithelial defects, microbial keratitis, corneal scarring and neovascularization.  
These issues are not specific to the study but with wearing/using new contact 
lens in general.   
 
8.0 
Data Collection and Management Procedures 
 Paper case report forms will be completed at each site.  
 De-identified data only will be entered into the RedCAP database by each 
investigator.   
 De-identified data will be stored in RedCAP for future analysis and 
publication.  
 
9.0 
Data Analysis 
 Final lens selection will be calculated for each randomization group.   
 Descriptive statistics will be used to compare logMAR visual acuity, comfort (OSDI and 
CLDEQ) and number of lenses ordered to achieve fitting for lens #1 and lens #2. 
Meibography will be analyzed.   
 
10.0 Quality Control and Quality Assurance 
 
The principal investigator will provide training for all co-investigators on 
recruitment, obtaining informed consent and proper filling out of case report 
forms. 
 
The principal investigator will review de-identified data entered into RedCAP 
after every 5 participants for completeness. REDCap limits will be used to 
ensure responses fall within appropriate ranges.  

Initial correction keratoconus: corneal gas permeable vs scleral lens 
 
Version 6 
Page 16 of 23 
04/28/2022 
 
The principal investigator will review de-identified data from each study sites 
to ensure data completeness and accuracy.  
 
11.0 Data and Safety Monitoring 
 
There will not be a data and safety monitoring committee for this study.  All 
study related problems will be identified and reported to the principal 
investigator. All co-investigators will be responsible for reporting safety 
concerns to the PI within 48 hours of occurrence.  
 
Adverse Events (AEs) will be collected and reviewed by the principal 
investigator within one business day.  
 
Unanticipated problems (UPs) will be detailed by co-investigators and reported 
to the principal investigator within one business day. Any study related AEs or 
UPs outside of usual contact lens related or contact lens handling problems 
will be reported to the IRB. 
 
A participant may elect to withdraw or stop participating in the study at any 
time.  
 
12.0 Statistical Considerations 
 
 
This is a pilot study to determine feasibility for a future randomized clinical trial. 
Descriptive statistics will be compiled.  
 
13.0 Regulatory Requirements 
13.1 Informed Consent  
 Informed consent will be obtained by the investigators at each site during 
routine ophthalmology or optometry visits.  
 The principal investigator will train the co-investigators to use a script to 
obtain informed consent.  
 Paper copies of informed consent documents will be provided to the study 
participant and maintained by the principal investigator in a locked file 
cabinet of locked office.  
 No minors will be enrolled in this study.  
 In person translators will be used to enroll non-English speaking 
participants if applicable. If in person translators are unavailable, the study 
visit can be rescheduled until an in person translator is available.  
13.2 Subject Confidentiality  
 Study participants will be recruited and complete informed consent in a 
clinical exam lane with a closed door by the principal investigator or co-
investigator. 
 Only the principal and co-investigators will have access to the study data 
for each participant at their individual site. 

Initial correction keratoconus: corneal gas permeable vs scleral lens 
 
Version 6 
Page 17 of 23 
04/28/2022 
 Study data will be de-identified and entered into the REDCap database. 
 After completion of the study, the master list linking participants to their 
study will be destroyed. 
 De-identified data only will be maintained in RedCAP for analysis and 
publication.  
 PHI will be viewed during routine clinical visits while viewing the electronic 
medical record.  
13.3 Unanticipated Problems  
 Adverse Events (AEs) and unanticipated problems (UPs) will be collected 
and reviewed by the principal investigator within one business day. 
 Any study related AEs or UPs outside of the usual contact related or 
contact lens handling problems will be reported to the IRB. 

Initial correction keratoconus: corneal gas permeable vs scleral lens 
 
Version 6 
Page 18 of 23 
04/28/2022 
 14.0 References 
 
 
1. Kennedy RH, Bourne WM, Dyer JA. A 48-year clinical and epidemiologic study of 
keratoconus. Am J Ophthalmol. 1986;101(3):267‐273. doi:10.1016/0002-
9394(86)90817-2. 
2. Krachmer JH, Feder RS, Belin MW. Keratoconus and related noninflammatory 
corneal thinning disorders. Surv Ophthalmol. 1984;28(4):293‐322. 
doi:10.1016/0039-6257(84)90094-8. 
3. Ortiz-Toquero S, Perez S, Rodriguez G, de Juan V, Mayo-Iscar A, Martin R. The 
influence of the refractive correction on the vision-related quality of life in 
keratoconus patients. Qual Life Res. 2016;25(4):1043‐1051. doi:10.1007/s11136-
015-1117-1. 
4. Cingu AK, Bez Y, Cinar Y, et al. Impact of Collagen Cross-linking on 
Psychological Distress and Vision and Health-Related Quality of Life in Patients 
With Keratoconus. Eye Contact Lens. 2015;41(6):349‐353. 
doi:10.1097/ICL.0000000000000129. 
5. Tatematsu-Ogawa Y, Yamada M, Kawashima M, Yamazaki Y, Bryce T, Tsubota 
K. The disease burden of keratoconus in patients' lives: comparisons to a 
Japanese normative sample. Eye Contact Lens. 2008;34(1):13‐16. 
doi:10.1097/ICL.0b013e3180515282. 
6. Kumar P, Bandela PK, Bharadwaj SR. Do visual performance and optical quality 
vary across different contact lens correction modalities in keratoconus? 
[published online ahead of print, 2020 Mar 29]. Cont Lens Anterior Eye. 
2020;S1367-0484(20)30052-7. doi:10.1016/j.clae.2020.03.009. 
7. Levit A, Benwell M, Evans BJW. Randomised controlled trial of corneal vs. 
scleral rigid gas permeable contact lenses for keratoconus and other ectatic 
corneal disorders [published online ahead of print, 2020 Jan 7]. Cont Lens 
Anterior Eye. 2020;S1367-0484(19)30268-1. doi:10.1016/j.clae.2019.12.007. 
8. Belin MW, Duncan JK. Keratoconus: The ABCD Grading System. Keratokonus: 
Das ABCD-System zur Stadieneinteilung. Klin Monbl Augenheilkd. 
2016;233(6):701‐707. doi:10.1055/s-0042-100626. 
9. Naderan M, Shoar S, Kamaleddin MA, Rajabi MT, Naderan M, Khodadadi M. 
Keratoconus clinical findings according to different classifications. Cornea. 
2015;34(9):1005–1011. 
10. Schiffman RM, Christianson MD, Jacobsen G, Hirsch JD, Reis BL. Reliability and 
validity of the Ocular Surface Disease Index. Arch Ophthalmol. 2000;118:615-
621. 
11. Chalmers RL, Begley CG, Moody K, Hickosn-Curran SB. Contact lens dry eye 
questionnaire-8 (CLDEQ-8) and opinion of contact lens performance. Optom Vis 
Sci. 2012; 89(10):1435-1442.

Initial correction keratoconus: corneal gas permeable vs scleral lens 
 
Version 6 
Page 19 of 23 
04/28/2022 
APPENDICES 
 
 
A. Eligibility Checklist 
-Diagnosis of keratoconus confirmed by slit lamp and topography. 
-No history of corneal surgery or INTACS (history of CXL okay) 
-No prior history of prior hybrid, corneal or scleral gas permeable lens use. 
-Age 18 or older 
-Willing to return for 4 study visits.  
Recruitment script: 
“You may qualify to participate in a research study for patients with keratoconus with 
corrective contact lenses. As part of the study, participants are fit with two types of 
contact lenses and asked questions about their experience with each lens type.  If 
you are interested in hearing more about the study I can provide more information 
and a copy of the written informed consent which outlines more details of the study.  
If you are not interested in participating in the study there will be no negative impact 
on your ongoing care.   
 
 
 
B. Data Collection Forms 
Study ID # 
Date of signed informed consent 
Randomization lens #1#2 or lens #2#1  
*Odd # study id will begin with lens #1. 
 
 
Study visit number 1  
.1 
Patient demographics 
.1.1 
Age 
.1.2 
Race 
.1.3 
Age diagnosed with keratoconus 
.2 
Past ocular and medical history including ocular procedures such as 
corneal collage crosslinking and corneal surgery. 
.3 
Best corrected visual acuity with manifest refraction  
.4 
Corneal curvature using topography   
.5 
Corneal pachymetry (thickness)  
.6 
Meibography  

Initial correction keratoconus: corneal gas permeable vs scleral lens 
 
Version 6 
Page 20 of 23 
04/28/2022 
.7 
OSDI questionnaire 
.8 
CLDEQ questionnaire  
.9 
Lens fitting data 
.9.1 
Trial lens 
.9.2 
CL fitting evaluation 
.9.3 
Over refraction and best corrected visual acuity. 
.9.4 
Subjective comfort with lens use rated on comfort scale of 0 (not 
comfortable) to 10 (very comfortable)  
 
 
Study visit number 2   
.1 
Randomization: lens type corneal gas permeable or scleral lens 
.2 
Time started/finished lens application and removal handling  
.3 
Best corrected visual acuity with lens #1   
.4 
Subjective comfort with lens use rated on comfort scale of 0 (not 
comfortable) to 10 (very comfortable)   
 
 
Study visit number 3 
.1 
Best corrected visual acuity with lens #1   
.2 
Hours of lens wear today, average hours of lens wear time, days per week 
of per week and daily time spent on lens application and removal  
.3 
Subjective comfort with lens use rated on comfort scale of 0 (not 
comfortable) to 10 (very comfortable)   
.4 
OSDI questionnaire 
.5 
CLDEQ questionnaire  
.6 
Time started/finished application and removal handling 
.7 
Best corrected visual acuity with lens #2   
.8 
Subjective comfort with lens use rated on comfort scale of 0 (not 
comfortable) to 10 (very comfortable)   
 
 
Study visit number 4  
.1 
Best corrected visual acuity with lens #2   
.2 
Hours of lens wear today, average hours of lens wear time, days per week 
of per week and daily time spent on lens application and removal   
.3 
Subjective comfort with lens use rated on comfort scale of 0 (not 
comfortable) to 10 (very comfortable)   
.4 
OSDI questionnaire 
.5 
CLDEQ questionnaire  
.6 
Participant final selection of lens of choice #1 or #2  
.7 
Participant final selection of lens of choice #1 or #2 given average self-pay 
cost of annual replacement. 
 

Initial correction keratoconus: corneal gas permeable vs scleral lens 
 
Version 6 
Page 21 of 23 
04/28/2022 
 
 
 
 
 
Non-study visits 
 
Lens #1- number of lenses needed to finalize  
 
Lens #2- number of lenses needed to finalize 
 
 
 
Unscheduled visits 
.1 Study ID 
Date 
Reason for unscheduled visit 
Lens type unscheduled visit is related to (corneal gas permeable or scleral lens) 
Lens loss 
Lens breakage 
Other problem (describe) 
Len cessation advised? Yes/No 
 
 
 
Adverse Event reporting 
Study ID 
Date 
Type of adverse event: 
Medical treatment required: 
Len cessation advised? Yes/No 
 
Questionnaires 
OSDI 12  
CLDEQ-8  

Initial correction keratoconus: corneal gas permeable vs scleral lens 
 
Version 6 
Page 22 of 23 
04/28/2022 
 
 

Initial correction keratoconus: corneal gas permeable vs scleral lens 
 
Version 6 
Page 23 of 23 
04/28/2022