IRB_ResearchPlan_AdultConsentForm_hw_Answers

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UCSD Human Research Protections Program New Biomedical Application RESEARCH PLAN Instructions for completing the Research Plan are available on the HRPP website. The headings on this set of instructions correspond to the headings of the Research Plan. General Instructions: Enter a response for all topic headings. Enter “Not Applicable” rather than leaving an item blank if the item does not apply to this project. Version date: 9/30/2013 1. PROJECT TITLE Study of a Hand-held Device Plus Mobile App Versus Standard Eye Care Devices in Measuring Refractive Error of the Eye 2. PRINCIPAL INVESTIGATOR James Peace, MD 3. FACILITIES United Medical Research Institute 4. ESTIMATED DURATION OF THE STUDY 1 day- 1 visit will be enough 5. LAY LANGUAGE SUMMARY OR SYNOPSIS (no more than one paragraph) The EyeQue Corporation has developed a hand-held device plus an app to measure the refractive error of the eye. The refraction values will be captured using 2 devices – Auto refractor and EyeQue VisionCheck. These refractive values will be used to prepare 2 sets of trial lens frames. n. Best-corrected visual acuity will be assessed using the ETDRS eye chart. For each subject, BCVA LogMAR scores will be collected for OD, OS, and OU for each of the 3 trial lens frames. They will also be asked a question regarding overall satisfaction with visual acuity using each of the 3 trial lens frames. Subjects will be monitored for adverse events and adverse device effects during the study 6. SPECIFIC AIMS 1. The primary objective of this study is to determine whether EyeQue VisionCheck is statistically non- inferior to the phoropter as assessed by best corrected visual acuity (BCVA) for each eye independently, measured using trial lens frames that correct the refractive error measured by each device, for the age stratum 45 through 65 years. 2. Assessing the similarity of refraction values (sphere, cylinder, axis) from the EyeQue VisionCheck compared with the phoropter through comparative plots and Pearson correlations 3. Determining whether EyeQue VisionCheck is statistically non-inferior to the autorefractor as assessed by BCVA measured using trial lens frames that correct the refractive error measured by each device 4. Determining whether EyeQue VisionCheck is statistically non-inferior to the phoropter as assessed by BCVA measured using trial lens frames that correct the refractive error measured by each device, for the age stratum 30 through 65 years. 5. To evaluate the safety of EyeQue VisionCheck compared with the phoropter and the autorefractor 7. BACKGROUND AND SIGNIFICANCE Uncorrected refractive errors account for more than 40% of the major causes for visual impairment globally The most common types of refractive errors include myopia, hyperopia, presbyopia, and astigmatism. When an individual has an uncorrected refractive error, symptoms may include blurred vision, double vision, haziness, squinting, headaches, and eye strain. Refractive error correction is accomplished through the use of eye glasses, contacts, or refractive surgery. However, not all of the population has access to optometrists/ophthalmologists and these diagnostic devices or can afford these exams. Additionally, for some instances it may be more convenient to be able to obtain refraction values outside of the clinic. The EyeQue Corporation is developing an inexpensive, portable, self-administered device to measure refraction values that can be used outside of the clinic. This device is a monocular refraction system consisting of 3 components: a mobile app, a cloud-based processing platform, and the VisionCheck optical device that attaches to a compatible smartphone owned/operated by the end user. The EyeQue app guides the subject through interactive measurements with the EyeQue VisionCheck device in order to determine refractive error. 8. PROGRESS REPORT

Page 2 The QC review comments are added by the National Library of Medicine (NLM). These comments indicate the location of apparent errors, deficiencies, or inconsistencies. These errors need to be corrected for further submission of the trial . 9. RESEARCH DESIGN AND METHODS This is a single-center, open-label, prospective study in healthy volunteers desiring refraction for correction of visual acuity to compare the EyeQue VisionCheck with the phoropter and autorefractor. Prior to enrollment of study subjects, both the phoropter and autorefractor devices will be calibrated following standard practice The subject will complete the following assessments and procedures at Screening to confirm eligibility. Once eligibility is confirmed, the subject will be enrolled and proceed with study testing procedures. The refraction values (sphere, cylinder, axis) for each subject (OD and OS) will be assessed using 2 additional devices: autorefractor and the EyeQue VisionCheck. Subjects will be assessed with the autorefractor using standard device methodology. The refraction values generated from the EyeQue VisionCheck, the autorefractor, and the phoropter (during screening) will be used to prepare 3 sets of trial lens frames. Pupillary distance, measured using the autorefractor, will be recorded for all subjects and will be used for preparation of trial lens frames. All subjects will be trained on how to use the EyeQue VisionCheck device prior to initiating testing. In order to obtain refraction values using the EyeQue VisionCheck, the subject will be required to take 1 practice test followed by a minimum of 3 saved tests for each eye using the EyeQue VisionCheck device and mobile app. After completion of a set of tests (1 test for each eye), the subject may elect to save or discard that set of tests. They may choose to discard for any reason which may include not following instructions, pressing the wrong button in error, etc. Each test consists of the subject looking through the EyeQue VisionCheck device and using the app controls to fully overlap red and green bars at 9 different angles. After completion of all tests (1 practice test and 3 saved tests with each eye), the refraction values will be displayed on the mobile app. These values will be used for preparation of the trial lens frames. If the EyeQue system determines that the overall test results are unreliable, subjects may have to complete 3 additional tests per eye before the system may be able to provide refraction values. Subjects will not be allowed to complete more than 6 saved tests and 1 practice with each eye. The system evaluates the statistical spread of the test results taken by the subject. If the spread is too large, the results are considered to be unreliable and values will not be provided. Such spread can be due to testing errors, improper instruction, etc. After the collection of refraction values from each device (phoropter, autorefractor, and EyeQue VisionCheck), the 3 trial lens frames will be prepared and given to the subject in a masked fashion. Best-corrected visual acuity will be assessed using the ETDRS eye chart. For each subject, BCVA LogMAR scores will be collected for OD, OS, and OU) for each of the 3 trial lens frames. Subjects will also be asked a question regarding overall satisfaction with visual acuity using each of the 3 trial lens frames. Subjects will be monitored for adverse events (AEs) and adverse device effects (ADEs) during the study The EyeQue VisionCheck is a self-administered, portable, monocular refraction system consisting of 3 main components: a mobile app, a cloud-based processing platform, and the VisionCheck optical device that attaches to a compatible smartphone owned/operated by the end user. The EyeQue app guides the subject through interactive measurements with the EyeQue VisionCheck device in order to determine refractive error. The device and mobile app operate on the inverse Shack-Hartmann principle described in patent US 8783871 B2, “Near Eye Tool for Refraction Assessment” (Pamplona V, US Patent, 2014). The EyeQue VisionCheck device is manufactured for EyeQue Corporation. This device is considered a nonsignificant risk medical device study that is subject to abbreviated investigational device exemption (IDE) regulations, and exempt from the requirement to submit an IDE application. The study will be conducted in accordance with GCP as contained in the US CFR governing the protection of

Page 3 human subjects 10. HUMAN SUBJECTS Approximately 200 subjects will be enrolled in this study to achieve a minimum of 100 evaluable subjects. The initial cohort included 39 subjects; therefore, approximately 160 additional subjects will be enrolled in the study. Subjects will be enrolled to obtain a population of approximately 35% in the age range of 30 through 44 years and approximately 65% in the age range of 45 through 65 years. Subjects will be screened for study participation and, if enrolled, will complete the testing procedures at the same visit. 11. RECRUITMENT AND PROCEDURES PREPARATORY TO RESEARCH Subject Inclusion Criteria Subjects must meet all of the following inclusion criteria to be enrolled in the clinical study: 1. Male or female 2. Age 30 through 65 years at time of consent 3. Binocular vision 4. Subject desires refraction for correction of visual acuity and vision (OU) can be corrected to 20/20 (LogMAR 0.0) 5. Willing and able to give informed consent and follow all study procedures and requirements 6. Ability to speak and understand the English language Subject Exclusion Criteria The presence of any of the following exclusion criteria excludes a subject from study enrollment: 1. Spherical correction > +8 or < -10 2. Using anticholinergic medications (including first-generation antihistamines) or other medications known to affect visual acuity within the greater of 3 days or 5 half-lives prior to enrolling in this study 3. Using an investigational drug or approved therapy for investigational use within the greater of 3 days or 5 half-lives prior to enrolling in this study 4. Has initiated any new medication in the past 2 weeks that, in the best medical judgment of the investigator, would impact their participation in the study or ability to use the EyeQue VisionCheck device 5. Eye disease, including but not limited to: • Glaucoma (≥ 22 mmHg intraocular pressure) • Cataracts (≥ 1+ nuclear sclerotic cataract, ≥ 1+ cortical, posterior subcapsular cataract [any grade using the Lens Opacities Classification System III]) • Macular degeneration (retinal pigmented epithelium mottlin g and/or any drusen within 500 µm of macula) • Eye infection (corneal ulcer, corneal infiltrates, superficial punctate keratitis) • Keratoconus • Diabetic neuropathy/retinopathy (≥ mild nonproliferative diabetic retinopathy) • Cytomegalovirus retinitis • C olor blindness (any color deficiency) • Diabetic macular edema (evidence of fluid) • Amblyopia • Chronic or acute uveitis (cells and/or flare in anterior chamber) • Strabismus (exotropia, esotropia, and hypertropia) • Abnormal astigmatism (mild to severe, > 5 diopters) • Macular hole 6. Eye surgery within the last 12 months (including Lasik or lens replacement) 7. Subject does not have the physical dexterity to properly operate the EyeQue VisionCheck device or the EyeQue app on the smartphone in the inves tigator’s opinion Screening procedures The subject will complete the following assessments and procedures at Screening to confirm eligibility: • demographics/medical history/concomitant medication review, • slit -lamp biomicroscopy, • laser retinal scan or fundoscopy, • optical coherence tomography (OCT) (retina and anterior chamber), • tonometry (non contact), • Ishihara color test, • cover test, • retinoscopy, • phoropter refraction, and • visual acuity with phoropter correction. During the OCT and laser retinal scan/fundoscopy, images will be taken of the retina, anterior chamber, and fundus. All eye procedures will be completed without dilation using standard

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Page 4 procedures. Retinoscopy will be used as a basis for further refinement by phoropter refraction. Refraction values (sphere, cylinder, axis) for oculus dexter (OD, right eye) and oculus sinister (OS, left eye) will be recorded for each subject using the phoropter 12. INFORMED CONSENT Subjects will not undergo any study-specific screening or testing procedures until written informed consent is obtained. A subject will be enrolled in the study after confirming that the subject has met all of the inclusion criteria and none of the exclusion criteria. 13. ALTERNATIVES TO STUDY PARTICIPATION Subjects may be withdrawn from treatment or assessment for the occurrence of an adverse effect or any other conditions that may create a safety risk. Subjects may also be withdrawn at the discretion of the investigator. Subjects can withdraw consent at any time for any reason without effect on subsequent care. Any enrolled subjects desiring to discontinue prior to study completion should be encouraged to discuss his or her reasons and concerns with the investigator. A subject who discontinues during the study visit prior to completion of all study procedures may be replaced. 14. POTENTIAL RISKS The device risk analysis and risk assessment were conducted in compliance with 21 CFR 820. Based on this assessment, the EyeQue VisionCheck is non-invasive and considered a low-risk device that requires periorbital surface contact. Even if the EyeQue VisionCheck is misused, the likelihood it will cause harm is low. The comparators in this study, phoropter and autorefractor, are used as part of standard eye exams. Most of the anticipated adverse effects are generally well tolerated and would be expected to occur infrequently. The risk and impact of these adverse effects is low. Based on the design and the intended use of the EyeQue VisionCheck, and given the low risk of potential adverse effects, this is considered a nonsignificant risk medical device study that is subject to abbreviated investigational device exemption (IDE) regulations, and exempt from the requirement to submit an IDE application. The following adverse effects may potentially occur with the use of the EyeQue VisionCheck device itself, the comparators, or the procedure used for the device: • Transient blurred vision • Transient dizziness • Headache • Transient eye irritation • Superf icial eye or periorbital infection 15. RISK MANAGEMENT PROCEDURES AND ADEQUACY OF RESOURCES The following approaches have been used to minimize risk in this investigation: • Subjects will be screened before receiving treatment to ensure they meet the protocol -defined inclusion and exclusion criteria. The inclusion and exclusion criteria have been developed to ensure appropriate subjects are included in the studied population and subjects with confounding conditions or conditions that could put them at risk are excluded from participation. • The test articles (i nvestigational and comparator devices) are intended for measuring refraction values and/or accessing BCVA. To minimize risk during the evaluations, the site staff will be trained on all devices and subjects will be instructed on how to use each device. The phoropter and autorefractor are both operated by the site staff. The EyeQue VisionCheck device will be operated by the subject and subjects will be trained in advance of completing testing with the device. The mobile app provides detailed instructions on how to operate the EyeQue VisionCheck device. Detailed instructions for the site staff to provide to subjects about the EyeQue VisionCheck are provided in the study operations manual. • To minimize the risk of eye irritation or infection, the devices will be sanitized between users.

Page 5 • Adverse device effects will be monitored throughout the study by site staff. The following concomitant medications and therapies are prohibited for the duration of the study and cannot be used within the greater of 3 days or 5 half- lives prior to enrolling in this study, unless otherwise specified: • Anticholinergic medications (including first- generation antihistamines) • Medications known to affect visual acuity • Investigational drugs or approved therapies for investigational use Medical Monitor and Emergency Contact Information: Rho, Inc. Medical Monitor Email: MedicalMonitorSupport@rhoworld.com Serious Adverse Event Reporting Contact Information: Rho, Inc. Safety Group Email: rho_productsafety@rhoworld.com Serious Adverse Event Help Line: 1-888-746-7231 Serious Adverse Event Fax Line: 1-888-746-3293 The investigator is responsible for informing the IRB of SAEs and UADEs as per local requirements, as well as according to applicable regulations 16. PRIVACY AND CONFIDENTIALITY CONSIDERATIONS INCLUDING DATA ACCESS AND MANAGEMENT According to ICH Good Clinical Practice (GCP) guidelines, the sponsor of the study is responsible for ensuring the proper conduct of the study with regard to protocol adherence and validity of data recorded on the eCRFs. The sponsor or its designee is responsible for assigning the study monitor(s) to this study. The investigator shall permit the study monitor to review study data as frequently as deemed necessary to ensure that data are being recorded in an adequate manner and that protocol adherence is satisfactory. The investigator shall access medical records for the study monitor so that entries in the eCRFs may be verified. The investigator, as part of his/her responsibilities, is expected to cooperate with the sponsor or designee in ensuring that the study adheres to GCP requirements. The investigator may not recruit subjects into the study until such time that a site visit has been made by an EyeQue or designee monitor to conduct a detailed review of the protocol and eCRF and study instructions. Prior to the start of the study, the investigator is responsible for ensuring that the protocol and informed consent form (ICF) have been reviewed and approved by a relevant IRB/IEC. The IRB/IEC shall be appropriately constituted and perform its functions in accordance with FDA, ICH GCP, and local requirements as applicable. The IRB shall approve all protocol amendments (except for logistical or administrative changes), written ICFs and documents updates, subject recruitment procedures (e.g. advertisements), written information to be provided to the subjects, available safety information, information about payment and compensation available to subjects, the investigator’s curriculum vitae and/or other evidence of qualifications and any other documents requested by the IRB and regulatory authority (competent authority) as applicable. 17. POTENTIAL BENEFITS There are no potential benefits from the device. It would just give hands on use of the device and app. 18. RISK/BENEFIT RATIO There is very minimal risk and minimal benefit and hence the ratio being very small 19. EXPENSE TO PARTICIPANT No expenses would be needed for the participants to pay. 20. COMPENSATION FOR PARTICIPATION It is a 1 visit program and a compensation of $40 would be given to each participant who finishes the entire procedure successfully along with food. 21. PRIVILEGES/CERTIFICATIONS/LICENSES AND RESEARCH TEAM RESPONSIBILITIES Conduct the investigation in accordance with the agreement, the investigational plan, 21 CFR Part 812, and other applicable regulatory requirements, and conditions of approval imposed by the reviewing institutional review board/independent ethics committee and appropriate regulatory agencies. 22. BIBLIOGRAPHY

Page 6 Pascolini D, Mariotti SP. Global estimates of visual impairment: 2010. Br J Opthalmol. 2012 May; 96(5): 614- 8. Pamplona V., Menezes de Oliveira Neto M., Mohan A., Raskar R. U.S. Patent No. US8783871 B2. 2014. World Health Organization (WHO). Blindness and vision impairment fact sheet. 11 October 2018. Online. 23. FUNDING SUPPORT FOR THIS STUDY EyeQue Corporation 39608 Eureka Drive Newark, CA 94560 24. BIOLOGICAL MATERIALS TRANSFER AGREEMENT No biological materials are involved in the trial. 25. INVESTIGATIONAL DRUG FACT SHEET AND IND/IDE HOLDER No drugs are involved. 26. IMPACT ON STAFF The staffs are held responsible for the training of the subjects to use the device and anything involved with the assessment of the device when the subject is using it. 27. CONFLICT OF INTEREST None 28. SUPPLEMENTAL INSTRUCTIONS FOR CANCER-RELATED STUDIES No cancer is involved in the studies 29. OTHER APPROVALS/REGULATED MATERIALS Not Applicable 30. PROCEDURES FOR SURROGATE CONSENT AND/OR DECISIONAL CAPACITY ASSESSMENT Not Applicable

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Page 7 [Instructions: Choose Edit...Select All, or click and drag to select all text below, then copy this text and paste it into your word processor consent document. Fill in the information noted in blue.] University of California, San Diego Consent to Act as a Research Subject Study of a Hand-held Device Plus Mobile App Versus Standard Eye Care Devices in Measuring Refractive Error of the Eye Who is conducting the study, why you have been asked to participate, how you were selected, and what is the approximate number of participants in the study? James Peace, MD, United Medical Research Institute is conducting a research study to find out more about a Hand- held device supported by a mobile application for solving refractive errors such as astigmatism . You have been asked to participate in this study because I have been having astigmatism . There will be approximately 120 participants at this site and approximately 230 participants at all sites. Why is this study being done? The purpose of this study is to evaluate the performance of a hand-held device supported by a mobile application compared with standard eye care diagnostic devices in measuring refractive error of the eye What will happen to you in this study and which procedures are standard of care and which are experimental? If you agree to be in this study, the following will happen to you: At first, an eligibility procedure will be performed like cover test, laser retinal test, retinoscopy, and such procedures. Once eligibility is confirmed, the subject will be enrolled and proceed with study testing procedures. The subjects will be trained to use the device and the app. Once this is done, different values will be measured to check the refractive error of the eye . [ If randomization is used to assign subjects to a study group include] You will be assigned by chance to a study group. Your chance of being assigned to each group is [fill in with the chance of assignment such as 1 in 3] . Neither you nor the researcher(s) can choose the group to which you will be assigned. [For each study group, fill in with an explanation of what will happen in the group indicating clearly the interventions that are different from standard of care] . - It was not a randomized experiment. We were placed in groups based on the age groups. [If a standard of care procedures are associated with the study, the following guidelines should be used to describe those standard procedures: a) If the standard procedure is not explicitly required by the study protocol, the consent form need not describe the procedure; or b) If the standard procedure is the main focus of the study (e.g., one or more of the study groups are randomized to standard of care) or is explicitly required by the study, the consent form must include a full description of the procedure.]

Page 8 The standard procedure was mentioned in the consent form. How much time will each study procedure take, what is your total time commitment, and how long will the study last? The experiment started on May 7 th 2019. The duration for the procedure is just 1 visit. All the procedures will be completed in 1 visit. What risks are associated with this study? Participation in this study may involve some added risks or discomforts. These include the following: Based on this assessment, the EyeQue VisionCheck is non-invasive and considered a low-risk device that requires periorbital surface contact. Even if the EyeQue VisionCheck is misused, the likelihood it will cause harm is low. The comparators in this study, phoropter and autorefractor, are used as part of standard eye exams. Most of the anticipated adverse effects are generally well tolerated and would be expected to occur infrequently. The risk and impact of these adverse effects is low. Based on the design and the intended use of the EyeQue VisionCheck, and given the low risk of potential adverse effects, this is considered a nonsignificant risk medical device study that is subject to abbreviated investigational device exemption (IDE) regulations, and exempt from the requirement to submit an IDE application. The following adverse effects may potentially occur with the use of the EyeQue VisionCheck device itself, the comparators, or the procedure used for t he device: • Transient blurred vision • Transient dizziness • Headache • Transient eye irritation • Superficial eye or periorbital infection [If this study involves exposure to radiation, please include the following two paragraphs:] During your participation in this research study, you will be exposed to radiation from scheduled x-rays and/or imaging scans. The total exposure resulting from these imaging studies is calculated to be approximately [fill in with appropriate amount of exposure] mSv. This amount is [more/less/equal — choose one] than you would receive from one year of natural exposure in the San Diego area, which is approximately 1.6 mSv. Cumulative exposure from radiation may increase your risk of developing certain types of cancer in the future. The principal investigator for this research study has determined and verified that [all/most/some — choose one] of the x-rays and/or imaging scans prescribed for this study would typically be performed as part of the standard medical care required to adequately monitor your current illness. [Investigator may be specific here by listing the scans that are considered standard of care if applicable or deemed to be useful information for the research subject. In addition, non- radiation producing imaging alternatives would be included here if described in the Research Plan.] If you are especially concerned with radiation exposure, or you have had a lot of x-rays or imaging scans already, you should discuss this with the principal investigator for this study, Dr. [fill in with name of principal investigator] , or your regular doctor. Study doesn ’t involve any radiation. Because this is a research study, there may be some unknown risks that are currently unforeseeable. You will be informed of any significant new findings. What are the alternatives to participating in this study? The alternatives to participation in this study are - Subjects will be screened before receiving treatment to ensure they meet the protocol-defined inclusion and exclusion criteria. The inclusion and exclusion criteria have been developed to ensure appropriate subjects are included in the studied population

Page 9 - To minimize risk during the evaluations, the site staff will be trained on all devices and subjects will be instructed how to use each device. The phoropter and autorefractor are both operated by the site staff. The EyeQue VisionCheck device will be operated by the subject and subjects will be trained in advance of completing testing with the device. The mobile app provides detailed instructions on how to operate the EyeQue VisionCheck device What benefits can be reasonably expected? There may or may not be any direct benefit to you from these procedures. The investigator(s), however, may learn more about the efficiency of the device, and usage of an app. Can you choose to not participate or withdraw from the study without penalty or loss of benefits? Subjects may be withdrawn from treatment or assessment for the occurrence of an adverse effect or any other conditions that may create a safety risk. Subjects may also be withdrawn at the discretion of the investigator. Subjects can withdraw consent at any time for any reason without effect on subsequent care. Any enrolled subjects desiring to discontinue prior to study completion should be encouraged to discuss his or her reasons and concerns with the investigator. A subject who discontinues during the study visit prior to completion of all study procedures may be replaced. You will be told if any important new information is found during the course of this study that may affect your wanting to continue. Can you be withdrawn from the study without your consent? You may be withdrawn from the study for the following reasons: • The subject is non -compliant with the study protocol • The subject has no refraction values produced with the EyeQue VisionCh eck device • At the investigator’s discretion, continued testing is medically contraindicated. You may also be withdrawn from the study if you do not follow the instructions given you by the study personnel. Will you be compensated for participating in this study? In compensation for your time and travel, you will receive $40 for participating in this research. The payment will be given to the participants at the end of all the 3 procedures. If a person withdraws from the study in between, then no compensation will be given. Are there any costs associated with participating in this study? There will be no cost to you for participating in this study. What if you are injured as a direct result of being in this study? [If this is an industry-sponsored study, please use the following:] If you are injured as a direct result of being in this study, treatment will be available. The costs of such treatment will be covered by the EyeQue Corporation or the study sponsors Paul TanPiengco and Noam Sapiens depending on a number of factors. . You may call the Human Research Protections Program Office at 858-246-HRPP (858-246-4777) for more information about this, to inquire about your rights as a research subject or to report research-related problems. In a medical emergency requiring immediate attention, study center staff will apply appropriate medical intervention, according to standards of care. An investigator shall notify the Medical Monitor and the reviewing IRB of any deviation from the investigational plan to protect the life or physical well-being of a subject in an

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Page 10 emergency. Such notice shall be given as soon as possible, but in no event later than 1 business day after the emergency occurred. Except in such an emergency, prior approval by the sponsor is required for changes in or deviations from a plan. All deviations must be documented. Medical Monitor and Emergency Contact Information: Rho, Inc. Medical Monitor Email: MedicalMonitorSupport@rhoworld.com Serious Adverse Event Reporting Contact Information: Rho, Inc. Safety Group Email: rho_productsafety@rhoworld.com Serious Adverse Event Help Line: 1-888-746-7231 Serious Adverse Event Fax Line: 1-888-746-3293 The investigator is responsible for informing the IRB of SAEs and UADEs as per local requirements, as well as according to applicable regulations What about your confidentiality? Research records will be kept confidential to the extent allowed by law. All participating subjects will be required to signify their approval to permit inspection of their medical records by representatives of EyeQue, the IRB/IEC, and regulatory agencies, as needed The investigator shall be provided with standardized eCRFs and shall ensure that all data from subject visits are promptly entered into the eCRFs in accordance with the specific instructions given. The investigator must sign each eCRF to verify the integrity of the data recorded. The investigator must maintain all source documents The investigator shall maintain adequate records for the study including copies of eCRFs for individual subjects, medical records, consent forms, test article disposition records, safety reports, information regarding participants who discontinued, and other pertinent data. The investigator shall maintain these records for a period of at least 2 years after the last approval of a marketing application and until there are no pending or contemplated marketing applications, or at least 2 years have elapsed since the formal discontinuation of clinical development of the test article. These records should be retained for a longer period if required by the applicable regulatory requirements or by an agreement with the sponsor. The sponsor will inform the investigator/institution as to when these records no longer need to be retained. [If the study includes investigator(s) who is/are not a “mandated reporter” of child or elder abuse, please use the following:] The investigators are not child or elder abuse. All subjects who enter the study will be assessed for safety. Safety will be monitored by observation of and direct inquiry regarding AEs during the study visit We may need to report information about known or reasonably suspected incidents of abuse or neglect of a child, dependent adult or elder including physical, sexual, emotional, and financial abuse or neglect. If any investigator has or is given such information, he or she may report such information to the appropriate authorities. [If the study involves genetic testing, please include the following:] Federal and State laws generally make it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. This law generally will protect you in the following ways: a) Health insurance companies and group health plans may not request your genetic information that we get from this research. b) Health insurance companies and group health plans may not use your genetic information when making decisions regarding your eligibility or premiums. c) Employers with 5 or more employees may not use your genetic information that we get from this research when making a decision to hire, promote, or fire you or when setting the terms of your employment. Be aware that these laws do not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long- term care insurance.

Page 11 We do not have any genetical testing. ClinicalTrials.gov Identifier: NCT03929588 Other Study ID Numbers: EYEQUE – 001 A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time. Who can you call if you have questions? James Peace, MD United Medical Research Institute has explained this study to you and answered your questions. If you have other questions or research-related problems, you may reach James Peace, MD United Medical Research Institute has at 6583197273 You may call the Human Research Protections Program Office at 858-246-HRPP (858-246-4777) to inquire about your rights as a research subject or to report research-related problems. Your Signature and Consent You have received a copy of this consent document and a copy of the “Experimental Subject's Bill of Rights” to keep. You agree to participate. Daksha Ramananda ________________________________________________ 04-03-2022_____________ Subject's signature Date