The following pages contain information on the following updates

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1 April 22, Clinical Study Update The following pages contain information on the following updates 1. Published Studies a. MUSC Published b. Arnold Published c. Silbert/Matta Published 2. Pending Posters a. NECO/BCH ARVO Poster b. MUSC Poster 3. Recently Released Posters a. MUSC Poster b. Vanderbilt Poster c. Arnold Poster 4. Previously Released Posters a. Vanderbilt Poster 5. Studies in Progress a. CBO Study/Brazil b. NECO Studies c. Vanderbilt pediatric practice study d. MUSC prospective studies

2 1a Published Study - MUSC Prospective evaluation of the Spot vision screener as an autorefractor and in the detection of amblyogenic risk factors compared to Plusoptix and a comprehensive pediatric ophthalmology examination Author: Medical University of South Carolina Published: Ocular Surgery News, May 2013 Spot Software: Conclusion: Spot is an effective pediatric vision screener comparable to the Plusoptix. Proposed modifications to the manufacturers criteria may be useful for Spot and Plusoptix Key Results: Spot s capture rate was 98.8% compared Plusoptix 68.4%. Estimates of refraction with the Spot are comparable to that of the Plusoptix, and the MUSC data supports use of these devices as vision screeners with modified criteria. PVH Comments: Spot s capture shows a high level of reliability in this enriched population. Also supporting fewer peaks/valleys in sensitivity/specificity inherent with low capture rate devices.

3 1b. Published Study - Arnold Performance of four new photoscreeners on pediatric patients with high risk amblyopia Author: Arnold, Armitage Published: JPOS Jan/Feb 2014 (adapted from AAPOS 13 and AAP 13 posters) Spot Software: Conclusion: Even in high risk and young children, current instrument-based screeners can reliably screen for refractive and strabismic risk factors that lead to amblyopia. Some devices can reduce the proportion of inconclusive results in challenging cases. (Spot) Results: One hundred eight children aged 1 to 12 years participated, with 56% having amblyopia risk factors and 10% having autism. For the four devices, sensitivity, specificity, and inconclusive results were as fol- lows: PlusoptiX (83%, 86%, 23%), SPOT (80%, 85%, 4%), iscreen (75%, 88%, 13%) and iscreen (with Delta Center Crescent) (92%, 88%, 0%), and GoCheckKids (with Delta Center Crescent) (81%, 91%, 3%). PVH Comments: Most notable on this study are the inconclusive results. Spot had a low inconclusive result of 4%, iscreen 13% and Plusoptix 23%. The effect on sensitivity/specificity is significant when including or not including the exam results from the inconclusive results (automatic referrals). The impact on sensitivity/specificity for competing devices adjusted results to 60%/65% for iscreen and 52%/55% for Plusoptix.

4 1c. Published Study Silbert/Matta Performance of the Spot Vision Screener for the detection of amblyopia risk factors in children Author: Silbert, Matta Published: JPOS Mar/Apr 2014, adapted from AOA 12 and ARVO 13 posters Spot Software: Conclusion: The Spot is a fully portable, automated tool for the detection of amblyopia risk factors in children. In this study cohort it was found to reliably detect amblyopia risk in children when compared to the 2003 and 2013 AAPOS referral criteria. Results: Compared to the cycloplegic pediatric ophthalmology examination, the positive predictive value of the Spot to detect 2013 AAPOS referral criteria was 86%; the negative predictive value, 75%; the sensitivity, 87%; and the specificity, 74%. PVH Analysis: Highly enriched screening environment on patients currently under care for vision issues in an ophthalmology clinic; results from Spot consistent with photo-refraction devices. Adjustments to criteria settings can move sensitivity & specificity results on Spot

5 2a. Pending Release NECO/BCH Accuracy of the Spot Pediatric Vision Screener for Detection of Hyperopia, Astigmatism and Anisometropia Authors: Moore, Gaiser, Solaka, Ledoux, Sandoval, Shah, Rook, He Institutions: New England College of Optometry, Boston Children s Hospital Conclusions: With all three predictors combined, the AUC (0.87) was similar to results of other devices examined by VIP. The results for the most hyperopic meridian and for the eye with the most astigmatism, AUC 0.71 and 0.84, were also similar. Data collection for this study is still ongoing. The AUC for anisometropia, 0.66 was based on SER that may mask hyperopia and was also similar to results reported by the VIP. Results: Based on a single predictor, eye with most hyperopic meridian and eye with most astigmatism the AUC was 0.71, 95% CI (0.622, 0.796) and 0.84, 95% CI (0.77, 0.91), respectively. For anisometropia, interocular difference in SER, the AUC was 0.66, 95% CI (0.58, 0.75). The aggregate of all three predictors combined AUC was 0.87, 95% CI (0.80, 0.94). PVH Commentary: This study validates Spot on par with VIP results. First significant analysis of Spot where all passed and referred screenings were evaluated with a comprehensive eye examination. Discussions with the authors indicates that Spot has never before seen capture rates. Unlike the published studies to date, this study was conducted at multiple public screening environments which indicates results would likely be duplicated by lay-person screeners. Showing Spot to be commensurate with the device s intended use; implemented on a wide variety of environmental conditions and on a broad-base of ethnic backgrounds.

6 2b. Pending Release - MUSC Prospective Evaluation of autorefraction using the Spot and Plusoptix A09 vision screeners in children ages months for the detection of amblyogenic risk factors Authors: Davidson, Peterseim, Cheeseman, Trivedi, Papa, Kraus Institution: Medical University of South Carolina Conclusion: Preliminary results suggest that the Spot and the plusioptix are efficacious autorefractors for young children. The Spot is more effective at obtaining a reading, however is less accurate than the plusoptix when refraction is obtained. Results: Currently 9 children ages months (testability Spot 100%, plusoptix 44.4%), 13 ages months (Spot 64.7%, plusoptix 23.5%), and 33 age months (Spot 82.9%, plusoptix 48.6%) were included in analysis with a goal of 30 per group. Compared to cycloplegic retinoscopy, the Spot underestimates sphere by 0.89D +/-1.48 (p<0.001) and overestimates cylinder by 0.49D +/-0.89 (p<0.001). The plusoptix underestimates sphere by 0.53D +/-0.91 (p<0.009) and overestimates cylinder by /-0.56 (p<0.002). PVH Commentary: Spot continues to show its superior capture rates compared to the competition. While the study suggests that Plusoptix is more accurate (when able to capture), without seeing the ROC curves is it difficult to accurately comment. What is obvious is that Spot s refractive measurements are being analyzed on all of it captures, which are almost double that of Plusoptix. It is expected that ROC curves will show variances consistent with Spot s accuracy claims in the IFU for patients outside -3.00D and +3.00D ranges; patients Plusoptix is likely not capturing.

7 3a. Recently Released Posters Comparison of the Spot and plusoptix AO9 vision screeners for the detection of refractive error in various ethnic groups Spot Software: Author: Medical University of South Carolina Conclusion: The Spot and plusoptix vision screeners identify refractive error, and the results are comparable to cycloplegic refraction. They both overestimate cylindrical power in Hispanics and African Americans. Results: 30 Hispanic/Latinos (Hispanics), 133 African Americans (AA), and 203 non- Hispanic whites (Caucasians) with an average age of 5.96, 5.59, and 5.64 years were included. The percentage of patients with > 3.00 D cylinder on cycloplegic refraction is 23.3% for Hispanic/Latino, 5.26% for AA and 2.96% for Caucasians. The Spot overestimated cylinder by 0.33D +/- 0.60D (p< 0.007) in Hispanics and 0.43D +/ (p<0.001) in AA. The plusoptix overestimated cylinder by 0.82D +/ (p<0.001) in Hispanics and by 0.58D +/ (p<0.001) in AA. PVH Commentary: Spot showed more accurate in estimating cylinder measurements in most analysis. Accurate cylinder measurements not only have effects the estimation of astigmatism readings on photo-refraction devices, but are key to proper estimation of spherical equivalent. Spherical equivalent measurements impact the pass/refer results for hyperopia, myopia and anisometropia.

8 3b. Recently Released Poster Calibration of a new remote autorefractor, the 2WIN compared to PlusoptixS12 and SPOT with amblyopic patients Author: Bob Arnold Spot Software: Conclusion: The new 2WIN is a promising addition to portable photoscreeners for amblyopia detection and estimating refractive error. Results: 62 children, aged 1-10, mean 5.2, were screened with all three devices before cycloplegic examination. Refractive results were inconclusive due to pupil size, cooperation and out-of-range values. Values for sensitivity (91% and 78%), specificity (71% and 59%) and inconclusive rate (10% and 13%) for Plusoptix and SPOT. The 2WIN was cali- brated for this age range yielding 71% sensitivity, 67% specificity and inconclusive rate 5%. Regression comparing Plusoptix, SPOT and 2WIN to exam respectively for sphere was (r2: 0.76, 0.87, 0.58) for cylinder power (r2: 0.67 vs 0.56 and 0.50) and axis (r2: 0.71 vs 0.41 and 0.40). PVH Commentary: The promising tag from a clinical perspective does not indicate that a device is easily implemented into general screening protocols. Upon reviewing the poster during AAPOS 14, it was identified that the criteria thresholds were significantly altered from manufacture settings on both Spot and Plusoptix; significantly favoring Plusoptix by as much as 1.50D on some settings.

9 3c. Recently Released Poster Field evaluation of the SPOT and PlusoptiX S08 vision screeners Spot Software: Author: Vanderbilt University Conclusion: PlusoptiX with modified Arthur criteria produces good referral rate and PPV. Children missed by the plusoptix, but referred by SPOT are few in number and do not have advanced pathology. Results: Two thousand eight hundred and one children were screened using SPOT. Three hundred and seven (11.0%) were referred by SPOT and then screened by plusoptix. Of the 102 children who received adequate GSEs, 42 referred by SPOT had ARFs (PPV 41.2%), while the PPV for plusoptix was 69.6% (32/46). Ten of 56 children referred by SPOT had ARFs that would have been missed by plusoptix; two had amblyopia of two lines while the others had no amblyopia. PVH Commentary: A review of the poster at AAPOS indicates that Spot criteria were altered to present high sensitivity while the Plusoptix criteria were altered to present high specificity. The results do not appear to be apples-to-apples comparison to Plusoptix as 2,500 Spot screenings occurred without a Plusoptix screening. Only 307 were screened by both devices and 107 received eye exams. Of the 107 exams, 10 of the amblyopic risk patients accurately identified by Spot were missed by Plusoptix.

10 4a. Previously Released Poster Validation of Spot screening device for amblyopia risk factors in a pediatric ophthalmology clinic setting Spot Software: Author: Vanderbilt University Conclusion: The original manufacturer s software has demonstrated a very high sensi- tivity to detect ARFs, but a low specificty; the v software update has greatly in- creased the specificity with minimal impact on sensitivity. Results: 217 children were screened by Spot (n=80 had amblyopia, n=153 had ARFs); 157 children were referred, and 60 passed. Using the original software (v1.0.3), Spot had a sensitivity of 91% and a specificity of 73% to detect ARFs. The updated software (v1.1.51) was applied to 157 patient records in a masked manner, and specificity (83%) improved substantially while sensitivity (84%) was minimally affected. PVH Commentary: Vanderbilt University shared the eye exam data from this poster which allowed for PVH internal evaluation. A review document is being prepared to share with Vanderbilt for further data analysis.

11 5. Studies in Progress CBO Study 1. Study by reputable Ophthalmologist as part of the registration process for Spot in Brazil. Full details at release of study, expected upon completion of Envisa. New England College of Optometry 1. Additional analysis underway to expand on the ARVO 14 poster. Working towards a properly powered study of over 700 subjects, include eye examinations on 100% of the cohorts selected for the study. Vanderbilt University 1. Data capture from 12 pediatric practices in the Nashville area along with eye examinations. Expect 3,000 screens, 300 eye exams. Medical University of South Carolina 1. MUSC/Peterseim poster released at AAPOS 2013 is continuing analysis and evaluating the results with Spot s version software. Currently showing data on over 400 patients exists. MUSC indicates they will share exam data at the conclusion of the study.