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

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.

IRB_ResearchPlan_AdultConsentForm_hw_Answers

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