Patient Reported Outcomes on Vision Quality and Dry Eye Following Treatment With Wavelight LASIK
Conditions: Myopia
Sponsor: OVO LASIK + Lens

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Patient Reported Outcomes on Vision Quality and Dry Eye Following 
Treatment with Wavelight LASIK  
An investigator-initiated clinical trial 
1.  TITLE PAGE 
 
Protocol Number: 
ML-24-01  
Amendment Number 
Version 1.0 
IRB / ERC 
Advarra IRB 
6940 Columbia Gateway Drive, Suite 110 
Columbia, MD 21046 
 
 
Sponsor Name & Address: 
Mark C. Lobanoff, MD  
OVO Lasik and Lens LLC  
6099 Wayzata Boulevard Saint Louis Park, MN 55416 
 
(funding only, this is an investigator-initiated study 
IIT # 92645913) 
Alcon  
6201 South Freeway,  
Fort Worth, TX 76134-2099, USA  
 
 
Test Articles: 
WaveLight® EX500 
 
 
 
 
 
 
 
 
 

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2 . INVESTIGATOR AGREEMENT 
 
I confirm that I have read and that I understand this protocol and understand the 
use of the study products. I agree to conduct this study in accordance with the 
requirements of this protocol and also protect the rights, safety, privacy, and well-
being of study subjects in accordance with the following: 
 
• 
The ethical principles that have their origin in the Declaration of Helsinki. 
• 
All applicable laws and regulations, including, without limitation, data privacy 
laws and regulations. 
• 
Regulatory requirements for reporting serious adverse events defined in Section 
13 of this protocol. 
 
 
 
 
Signature of Investigator  (Date) 
 
Investigator Name (print or type) 
 
Investigator’s Title 
 
Name of Facility 
 
Location of Facility (City) 

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3.  GENERAL INFORMATION 
 
Objective 
To assess patient subjective response regarding satisfaction of vision 
following Wavelight LASIK.   
 
The hypothesis is that a high percentage of subjects will be completely 
satisfied/very satisfied with vision following Wavelight LASIK.  
 
Test Article(s)   
WaveLight® EX500 
Control Article(s) 
None. 
 
Sample size  
300 subjects 
Study Population 
Subjects 21 to 35 years (at the time of surgery) who underwent Wavefront 
Optimized or Phorcidies Planned Contoura LASIK for myopia or myopic 
astigmatism 12 to 15 months prior. 
 
Number of sites 
Four 
Study Design 
Multi-site, single-arm, ambispective, observational study 
Masking 
None 
Variables 
Primary:  Percentage of subjects satisfied (Completely Satisfied or Very 
Satisfied) with vision after Wavelight LASIK based on a modified 
PROWL Questionnaire (Question #1 only). 
 
Secondary: 
• 
Remaining questions on the modified PROWL Questionnaire 
• 
Mean postoperative OSDI and the percentage of patients 
asymptomatic (< 12).  
• 
Percentage of subjects using artificial tears or prescription dry eye 
medication.  
 
Duration / Follow-up 
12+ months postoperative. 
 
The study will be registered with clinicaltrials.gov.  
 
The study will be conducted in compliance with the protocol, GCP and applicable 
regulatory requirements 
 

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4.  TABLE OF CONTENTS 
1.  TITLE PAGE .............................................................................................................................. 1 
2 . INVESTIGATOR AGREEMENT .................................................................................................. 2 
3.  GENERAL INFORMATION ........................................................................................................ 3 
4.  TABLE OF CONTENTS .............................................................................................................. 4 
5.  INTRODUCTION ...................................................................................................................... 6 
6.  OBJECTIVE(S) .......................................................................................................................... 6 
7.  SUBJECTS ................................................................................................................................ 6 
7.1. Subject Population ...................................................................................................... 6 
7.2. Inclusion Criteria ......................................................................................................... 6 
7.3. Exclusion Criteria ......................................................................................................... 6 
8.  STUDY DESIGN ........................................................................................................................ 7 
8.1. Study Design ................................................................................................................ 7 
8.2. Methods Used to Minimize Bias .................................................................................. 7 
9.  STUDY PROCEDURE ................................................................................................................ 7 
9.1. Informed Consent / Subject enrollment ..................................................................... 7 
9.2. Visits and Examinations ............................................................................................... 8 
9.3. Study Methods and Measurements ............................................................................ 8 
9.4.  Unscheduled Visits ..................................................................................................... 8 
9.5.  Discontinued Subjects ................................................................................................ 8 
10.  ANALYSIS PLAN ..................................................................................................................... 9 
10.1. Analysis Data Sets ...................................................................................................... 9 
10.2. Statistical Methodology ............................................................................................ 9 
10.3. General Statistical Considerations ............................................................................ 9 
11.  SAMPLE SIZE JUSTIFICATION ................................................................................................ 9 
12. CONFIDENTIALITY/PUBLICATION OF THE STUDY .................................................................. 9 
13.  QUALITY COMPLAINTS AND ADVERSE EVENTS .................................................................. 10 
14. GCP, ICH and ETHICAL CONSIDERATIONS ........................................................................... 10 
14.1 Confidentiality .......................................................................................................... 10 
15.  STANDARD EVALUATION PROCEDURES ............................................................................. 11 
Table 15.1. Proposed Visits and Study Assessments ........................................................ 11 

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16. CONFIDENTIALITY ................................................................................................................ 11 
17. STUDY ENDPOINT CRITERIA ................................................................................................ 11 
17.1. Patient Completion of Study ................................................................................... 11 
17.2. Patient Discontinuation ........................................................................................... 11 
17.3. Patient Termination ................................................................................................ 11 
17.4. Study Termination ................................................................................................... 11 
17.5. Study Completion .................................................................................................... 12 
18. SUMMARY OF RISKS AND BENEFITS .................................................................................... 12 
18.1. Summary of risks ..................................................................................................... 12 
18.2. Summary of benefits ............................................................................................... 12 
19. MOBILE APP ........................................................................................................................ 12 
REFERENCES .............................................................................................................................. 14 
 
 
 

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5.  INTRODUCTION 
Early LASIK was associated with dry eye and often glare and halo complaints. This may 
have been due to microkeratome-cut flaps and the excimer ablation treatment patterns 
available at the time. Now, modern LASIK combines femtosecond laser-created flaps 
with more advanced excimer ablation treatment patterns. However, there are limited data 
on patient reported outcomes for dry eye symptoms and quality of vision for modern 
LASIK.  
 
The purpose of this study is to assess patient subjective response regarding satisfaction of 
vision following Wavelight LASIK.   
6.  OBJECTIVE(S) 
To assess patient subjective response regarding satisfaction of vision following 
Wavelight LASIK.   
7.  SUBJECTS 
7.1. Subject Population  
Eligible test subjects will be 21 to 35 years of age (at the time of surgery) and who 
underwent Wavefront Optimized or Phorcidies Planned Contoura LASIK for myopia or 
myopic astigmatism 12 to 15 months prior. 
 
A total of 300 subjects at four sites will be enrolled. Subjects must meet the inclusion 
criteria. Prior to enrollment, subjects will be provided information on the study and asked 
to sign a patient information and consent form to participate. The patient information and 
consent form will be approved by an appropriate ethics committee. 
7.2. Inclusion Criteria 
Subjects are eligible for the study if they meet the following criteria: 
Note: Ocular criteria must be met in both eyes. 
• Wavefront Optimized or Phorcidies Planned Contoura LASIK for myopia or 
myopic astigmatism 12 to 15 months ago 
• Age: 21 to 35 years of age at the time of surgery.  
• Preoperative myopic sphere of -1.00 D to -8.00 D 
• Preoperative regular astigmatism of 0.00 D to -3.00 D.  
• Stable refraction preoperatively defined as < 0.5 D of change over at least 1 year.   
• Refractive target of bilateral emmetropia. 
7.3. Exclusion Criteria 
If any of the following exclusion criteria are applicable to the subject or either eye, the 
subject should not be enrolled in the study. 

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• Corneal ectatic disorders.  
• Patients with a calculated residual stromal depth of < 300 um.  
• Pre-existing retinal or corneal pathology, or irregular astigmatism. 
• Pre-existing autoimmune diseases, dry eye, glaucoma, diabetes, etc. 
• Previous corneal surgeries prior to LASIK. 
• LASIK enhancements.  
The principal investigator reserves the right to declare a patient ineligible or non-
evaluable based on medical evidence that indicates they are unsuitable for the trial.  
8.  STUDY DESIGN 
8.1. Study Design  
This study is a multi-site, single-arm, ambispective, observational study of subject 
satisfaction, after successful bilateral LASIK surgery. Subjects will be assessed 12+ 
months post-operatively. Clinical evaluations will include administration of the OSDI, 
modified PROWL, and dry eye questionnaires. 
 
Primary:  Percentage of subjects satisfied (Completely Satisfied or Very Satisfied) with 
vision after Wavelight LASIK based on a modified PROWL Questionnaire (Question #1 
only). 
 
Secondary outcome measures are as follows: 
• Remaining questions on the modified PROWL Questionnaire 
• Mean postoperative OSDI and the percentage of patients asymptomatic (< 12).  
• Percentage of subjects using artificial tears or prescription dry eye medication.  
8.2. Methods Used to Minimize Bias  
As a single-arm study there is no expected bias. Patient selection will be based on the 
patient’s interest and the surgeon’s opinion as to whether they are a suitable candidate for 
inclusion. 
 
Questionnaire instructions will be provided to all patients in a similar manner. 
 
All data collection will be completed through provided Case Report Forms (CRFs) or 
computer files. All site personnel involved in the study will be trained in regard to 
conducting study-specific procedures. 
9.  STUDY PROCEDURE  
9.1. Informed Consent / Subject enrollment  
No subject will be enrolled into the study who does not meet the inclusion/exclusion 
criteria and does not sign the current approved informed consent document. Informed 
consent will be obtained prior to collecting any data for the study. The original signed 
documents will be maintained by the investigator as a permanent part of the subject's 
medical records. A signed copy will be provided to the subject.  

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9.2. Visits and Examinations  
Subjects will participate in 1 study visit, at least 12 months postoperative.  Details of each 
study visit, including testing to be conducted, are provided below.  
 
9.2.1. Screening and Questionnaires  
 
After subjects are consented, they will be qualified for the study (compared with 
inclusion/exclusion criteria) and assigned a study ID/subject number.  Subject 
numbers will be assigned sequentially at each site in the order of enrollment. 
 
Exams will include the tests described below: 
§ OSDI questionnaire, 
§ PROWL questionnaire, 
§ Dry eye questionnaire 
 
Measurements should be made as described in section 9.3 below.  
9.3. Study Methods and Measurements 
 
 
9.3.1. Questionnaire 
The PROWL, ODSI, and dry eye questionnaires will be administered to subjects 
through a mobile app.  
 
The mobile app asks patients questions from the The PROWL, ODSI, and dry eye 
questionnaires, and patients choose an answer from 4-5 choices.  The app records 
the patient's answer, which are subjective opinions about how the patient feels 
about their vision.  There are no measurements.  Accuracy of recording the 
answers is 100%. 
9.4.  Unscheduled Visits 
Unscheduled exams may be conducted at the discretion of the Investigator with all 
relevant information from the exam recorded in the source documents and on the 
Unscheduled Visit pages within the CRF booklet. 
9.5.  Discontinued Subjects 
Discontinued subjects are those who do not have an exit visit or who come into the office 
to be exited prior to the scheduled final study visit. Subjects may be discontinued from 
the study at any time if, in the opinion of the investigator, their continued participation in 
the study poses a risk to their health. Subjects can deactivate the app at any time, and 
investigators can suspend the app/survey at any time. 
 

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10.  ANALYSIS PLAN 
10.1. Analysis Data Sets 
All subjects who are enrolled in the study will be evaluated for safety.  Efficacy analyses 
will be performed based on data from those eyes that completed the study.   
10.2. Statistical Methodology 
A summary of the data will be prepared for all measurement time points.  
 
For variables measured on a continuous scale, these summaries will include the sample 
size, as well as the mean, standard deviation, median, minimum, and maximum. For 
variables measured on a categorical scale, summaries will provide the number and 
percentage of subjects in each category. These summaries will be provided for all eyes 
completing the study. 
10.3. General Statistical Considerations 
The statistical analyses will be performed using R, version 4.4.0 or higher.  Any 
statistical tests of hypotheses will employ a level of significance of alpha=0.05. 
11.  SAMPLE SIZE JUSTIFICATION 
We estimate that the study would require a sample size of 300 subjects to characterize 
patient subjective responses regarding vision, satisfaction of perceived outcomes, and dry 
eye symptoms following Wavelight LASIK surgery. 
12. CONFIDENTIALITY/PUBLICATION OF THE STUDY 
The existence of this Study is confidential and should not be discussed with persons 
outside of the Study. Results will be submitted for publication and presentation at 
national and/or international meetings. A manuscript will be submitted to peer-review 
journals for publication but there is no guarantee of acceptance. 
 
All study data will be collected on appropriate Case Report Forms (CRFs). No protected 
health information will be included on the forms. CRFs will be retained in the patient’s 
file for a minimum period of 3 years. Collected information will only be used for 
purposes of this study and no information will be sold to third parties. The following 
people will have access to your study records:  
 
•    Study Doctor and staff involved with the study 
 
•    Study Monitor or Auditor 
 
•    Sponsor Company or Research Institution 
 
•    Review boards or accrediting agencies 
 
•    Other State or Federal Regulatory Agencies 

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The de-identified data may be shared with other researchers for future analysis. 
 
13.  QUALITY COMPLAINTS AND ADVERSE EVENTS 
 
Study contact information is provided below. 
 
Table 13.3.-1:  
Contact Information for Study 
Project Manager 
Business Phone 
e-mail 
Mark C. Lobanoff 
952-204-9711 
mark.lobanoff@ovoeye.com 
 
 
14. GCP, ICH and ETHICAL CONSIDERATIONS 
This study will be conducted in compliance with Good Clinical Practices (GCPs), 
including International Harmonization (ICH) Guidelines, and in general, consistent with 
the 1996 version of the Declaration of Helsinki.  In addition, all applicable local, state 
and federal requirements will be adhered to. 
 
This study is to be conducted in accordance with Institutional Review Board regulations.  
The investigator will obtain appropriate IRB/ethics committee approval prior to initiating 
the study. 
 
The study will be registered with clinicaltrials.gov. 
 
14.1 Confidentiality 
The data collected will be data typical for the procedure(s) when performed on eyes 
outside the study. Any data collected will become part of the patient’s clinical record. 
The data will be subject to the same privacy and confidentiality as other data in the 
clinical record. 
 
Only the principal investigator, research consultant and clinic staff will have access to the 
data collected. All data shared outside the practice will be de-identified; patients’ 
protected health information will not be available and will not be reported in any analyses 
or publications. No data will be sold to third parties. De-identified data may be used for 
future research.  

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15.  STANDARD EVALUATION PROCEDURES  
Table 15.1. Proposed Visits and Study Assessments 
                  (visits are by patient, with both eyes tested) 
 
Activity 
Visit 1 
Informed Consent 
X 
PROWL Questionnaire 
X 
OSDI Questionnaire 
X 
Dry eye Questionnaire 
X 
Complete Exit Form1 
X 
 
1 Complete Exit Form upon termination of subject participation. 
16. CONFIDENTIALITY 
No protected health information (PHI), including the patient’s name and date of birth, 
will be collected; to ensure this, no PHI information is permitted to be entered on any of 
the Case Report Forms (CRFs). Subjects will only be identified by subject IDs and 
identities will be removed at the initial visit so that there is no further need to protect or 
destroy the information. Collected information will only be used for purposes of this 
study and no information will be sold to third parties. The non-PHI information collected 
may be used for future research, though there is currently no plan to do so.  
17. STUDY ENDPOINT CRITERIA 
17.1. Patient Completion of Study  
If a study patient has completed Visit 1, he/she is considered to have completed the study.  
 17.2. Patient Discontinuation  
Each study patient may voluntarily discontinue the study at any time they choose.  Study 
patients who cannot complete the study for administrative reasons (e.g., non-compliance, 
failure to meet visit schedule, etc.) will be discontinued from the study.  
 17.3. Patient Termination  
A study patient will be terminated if the study patient develops any severe adverse event 
that may be related to the study.  A study patient will receive appropriate treatment at the 
discretion of the investigator.  Notification of termination will be clearly documented.  
These study patients are considered to have completed the study and will not be replaced.   
17.4. Study Termination 
The investigator with appropriate notification may terminate the study.  If, after clinical 
observations, the investigator feels that it may be unwise to continue the study, he may 
stop the study.   

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17.5. Study Completion  
The study will be complete when all enrolled patients have completed Visit 1 or have 
been terminated from the study.   
18. SUMMARY OF RISKS AND BENEFITS 
18.1. Summary of risks 
There is no increased risk associated with the proposed study. 
18.2. Summary of benefits 
Previous studies have shown that the WaveLight® EX500 (Alcon, Fort Worth, Texas, 
USA) provides good visual outcomes for patients at distance.2,3  
19. MOBILE APP 
The mobile app is hosted on the Azure Cloud, leveraging an Infrastructure as a Service 
(IaaS) model. This approach allows the system to take full advantage of Azure’s scalable 
virtual machines, storage, and networking capabilities. By utilizing IaaS, the mobile app 
benefits from high availability, disaster recovery, and dynamic scaling, all without the 
complexity of managing physical hardware. 
 
With Azure Cloud in an IaaS configuration, the mobile app benefits from enhanced 
security and control: 
• Full Control: We manage all software layers, from the operating system to 
applications, allowing for customized security configurations. 
• Encryption Key Ownership: We maintain full ownership of encryption keys, 
ensuring complete data protection both at rest and in transit. Azure Key Vault or 
our own Key Management Service (KMS) can be utilized to secure key 
management. 
 
For authentication and authorization, the mobile app integrates two key technologies: 
• ASP.NET Core Identity: A robust membership system managing user accounts, 
roles, and security, supporting key features like user registration, password 
management, role-based access control, and claims-based identity. 
• IdentityServer4: A flexible OpenID Connect and OAuth 2.0 framework built on 
ASP.NET Core, enabling advanced scenarios such as single sign-on (SSO), API 
access delegation, and token issuance. 
 
In terms of data protection, Azure SQL Database and Azure Managed Disks offer 
encryption at rest through Transparent Data Encryption (TDE), which automatically 
encrypts data, backups, and transaction logs using AES-256 encryption. 
 
Additionally, all communication within the mobile app is secured over HTTPS, utilizing 
SHA-256 encryption for data in transit, ensuring robust protection both while stored and 
during transmission. 
 

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Study staff for each site will be trained on the app/survery technology.  They can answer 
any technical questions.  If they encounter a technical issue they don't know the answer 
to, the software designers of the app will be available to solve technical issues. 

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REFERENCES 
1. 
Kim T-i, Alió del Barrio JL, Wilkins M, Cochener B, Ang M. Refractive surgery. 
The Lancet. 2019;393(10185):2085-2098. 
2. 
Brunson PB, Mann II PM, Mann PM, Potvin R. Clinical Outcomes After 
Topography-Guided Refractive Surgery in Eyes with Myopia and Astigmatism – 
Comparing Results with New Planning Software to Those Obtained Using the 
Manifest Refraction. Clinical Ophthalmology. 2020;14:3975-3982. 
3. 
Stulting RD, Lobanoff M, Mann PM, 2nd, Wexler S, Stonecipher K, Potvin R. 
Clinical and refractive outcomes after topography-guided refractive surgery 
planned using Phorcides surgery planning software. J Cataract Refract Surg. 
2022;48(9):1010-1015.