M&S Clinical Trials Run Like Clockwork

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YEARS ® Run Clinical Trials Like Clockwork with the right technology Computerized Visual Function Testing for Ophthalmic Clinical Trials Automated ETDRS Linear Sine Wave Defocus Curve Contrast Acuity • Retina • IOL Therapeutic and Device Clinical Trials • G laucoma • C ontact Lens A Hilco Vision Company The First Choice in Vision Testing Systems

For almost 35 years, M&S Technologies software and hardware technologies have brought state-of-the-art computerized testing to vision care. Since our inception, we’ve invested millions of dollars in research and development. This has resulted in comprehensive testing features with unsurpassed accuracy and ease-of-use in all the products we provide to the field of vision care.

Runs clinical trials like clockwork with the right technology

Over 20 years ago, M&S Technologies was selected by a leading pharmaceutical company to develop computerized clinical trial testing to eliminate chart boxes, paper forms, and errors in reporting.

Today, the Clinical Trial Suite (CTS) provides researchers and sponsors a multitude of testing algorithms customized to meet the requirements of simple to complex clinical trials.

In compliance with the FDA, CTS test results are supported by validated studies that are peer reviewed and published by prominent universities and industry professionals. More than 50+ sponsors in 43 countries have used CTS in close to 200 clinical trials.

Table of Contents Your Global Testing Partner 1 Error-Free Data Transfer 2 Compliance 2 Automated ETDRS 3 DVA-5000 5 Automated ETDRS Contrast Sensitivity Testing Reference Chart 7 EVA e-ETDRS Electronic Visual Acuity 9 Defocus Curve 10 Contrast Acuity and Contrast Threshold Testing 11 Automated Contrast Sensitivity Function System (ACSFS) 12 Linear Sine Wave Grating 13 Glare Testing System (GTS) 14 5.5" Ultra High-Resolution Display 15 Distance One™ 16 Tablet Controller 17 Luminance Sensor 18 Web-Based Vision Testing 19 eLVTTM Electronic Low Vision Test 20 Calibrated Optotypes 21 Technical Support 22 Validated Published Studies 23 Standardized Testing Validated Accuracy FDA Recognized mstech-eyes.com 847-763-0500 ® A Hilco Vision Company The First Choice in Vision Testing Systems

CTS Changes Everything

Transitioning to computerized testing with immediate and accurate results is CRITICAL

CTS offers:

• ZERO Paper Forms and Calculation Errors

• ZERO Protocol Deviations

• ZERO Stopping Rule Violations

• ZERO Erroneous Test Results

• ZERO Secondary Reviewer Costs

• Technicians cannot deviate from sponsors testing protocols

M&S | Clinical Trial Suite CTS

Product of choice by major Pharmaceutical Companies and Research Institutions

Your Global Testing Partner

Offering Clinical Trial testing in over 43 countries

• Any symbol set can be selected and inserted to accommodate international investigator sites

• 24/7 Worldwide support

• Comprehensive training and certification services for trial sites worldwide

• Each trial is assigned a dedicated CTS Technical and Administrative Specialist to assist with study protocols and implementation

• Software updates and new studies added remotely

• Includes software warranty and technical support for duration of the trial

• CE marked for distribution to the EU. Compliance with Medical Device Regulations (MDR) in process

• C TS has been used in over 170 clinical trials with over 50 sponsors worldwide

FDA recognized for use in all phases of Clinical Trials, including PMA Trials. Conforms to all ANSI, ISO guidelines for vision testing. CE marked for distribution in the European Union.

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XLM, CSV, PDF format

Test data is immediately transmitted without errors, enabling you to access trial results instantly with results being exported to an EDC or Reading Center

Standard and customizable reports include:

• E TDRS numerical score

• Visual Acuity

• Contrast Acuity Level

• Contrast Threshold Level

• LogMAR value

• Defocus Curve results

Automated, Error-Free Data Transfer Compliance through Validation

Bio-statisticians require minimal data preparation to conduct analyses.

CTS test results are recognized by the FDA for use in all phases of clinical trials, based on studies that have been validated, peer reviewed, and published by prominent industry professionals.

Testing complies with all recommendations made by the US Food and Drug Administration for Clinical Trials.

• Optotypes are precisely calibrated for both distance-to-subject and pixels-per-inch to strictly comply with ANSI 280.21-2010 (R2015), ISO 8596:2017, and ISO 10938 guidelines regarding size, spacing between optotypes, and spacing between lines

• Standardized, background luminance is set to 85 cd/m2 as recommended by the FDA (ANSI/ISO), and can be customized from 80 to 320 cd/m2 to accommodate any trial requirements

• Luminance levels, Distance calibration, and Optotype spacing conform to all ANSI, ISO and FDA guidelines for vision testing

• CE marked for distribution to the EU. Compliance with Medical Device Regulations (MDR) in process

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Accurate
esting System SEND Results
results immediately uploaded

FASTER TESTING FASTER RESULTS

M&S | Clinical Trial Suite CTS
Automated ETDRS
Tablet Controlled Data-Entry Ensures Accuracy See page 23 for CTS peer-reviewed and published study information
Product of Choice by Major Pharmaceutical Companies
(CTS-1500)
Test Distances: 40 cm - 4 m
3 Select easiest line to read Number of correct letters Select correct letters only
Eliminate technician errors, bias, & stopping rule violations

TECHNICAL SPECIFICATIONS

Testing includes:

Visual Acuity

• Automated ETDRS

- NEAR 40 cm

- INTERMEDIATE 66 cm

- DISTANCE 4 m

- (Customizable to sponsor requirements)

• EVA e-ETDRS

• Defocus Curve

• MNREAD® Minnesota Reading Test

• eLVT TM Electronic Low Vision Testing

Contrast

• Contrast Acuity

• Contrast Threshold

• Contrast SensitivityLinear Sine Wave Gratings

• ACSFS Sinusoidal Bulls Eye

• Contrast Sensitivity with/ without Glare Photopic

• Contrast Sensitivity with/ without Glare Mesopic

• Testing sequences are programmed to eliminate technician deviation errors, bias, and Stopping Rule violations.

• System eliminates manual “paper” recording, including circling of letters, manual calculations, and errors in data upload.

• Distance calibration is adjustable to accommodate any test distance from 40 cm to 4 m.

• Computer-automated testing quickly and accurately guides technicians through test protocol for consistency, accuracy, and unbiased results.

• Optotype precisely calibrated for both distance to subject and pixels-per-inch, strictly following ANSI Z80.21, ISO 8596:2017, ISO 10938, ISO 17979 guidelines regarding size, spacing between optotypes, and spacing between lines.

• Monitor luminance is precisely calibrated utilizing a computer- integrated photometer following FDA guidance. Room luminance is measured and can be programmed to specific luminance conditions as required by the sponsor. Specific environment luminance levels can be programmed into the system which ensures consistency from site to site and visit to visit.

• Mesopic testing at 3 cd/m2 is available by utilizing a neutral density filter.

• Choose Sloan letters (10), British Standard Institution letters (12), Euro-wide letters (12), Tumbling E’s, Landolt C Rings, LEA Symbols®, LEA Numbers®

• Complete randomization of all optotypes, specifically following FDA guidance.

• Expor t test results automatically in an XML or CSV format to any EDC or Reading Center for immediate analysis.

FDA recognized for use in all phases of Clinical Trials, including PMA Trials. Conforms to all ANSI, ISO guidelines for vision testing. CE marked for distribution in the European Union.

®

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Accurate Testing at the Highest Level

DVA-5000 for Retina Focused Clinical Trials

Eliminate Paper forms, protocol deviations, Stopping Rule violations, and calculation errors

Expedite Decision Making

Results are immediately uploaded to an EDC/Reading Center with no calculation errors, Secondary Reviewer or manual data entry delays

Test Distances: 2.5 m - 4 m

Accurate Tablet Controlled Data Entry

The Tablet Controller quickly and accurately guides technicians through computer-automated testing resulting in consistent, repeatable, and unbiased test results

5 M&S | Clinical Trial Suite CTS
Select easiest line to read Number of correct letters Select correct letters only

®

Testing includes:

NEW! Stay informed with Instant Outlier Alerts customized to your requirements

Visual Acuity

• Automated ETDRS

• EVA e-ETDRS

• Contrast Sensitivity

• Defocus Curve

• MNREAD® Minnesota Reading Test EVA e-ETDRS

• eLVT TM Electronic Low Vision Testing Contrast

• Contrast Acuity

• Contrast Threshold

• Contrast Sensitivity with/ without Glare Photopic

• Contrast Sensitivity with/ without Glare Mesopic

TECHNICAL SPECIFICATIONS

• Testing sequences are programmed to eliminate technician deviation errors, bias, and Stopping Rule violations.

• System eliminates manual “paper” recording, including circling of letters, manual calculations, and errors in data upload.

• Distance calibration is adjustable to accommodate any test distance from 40 cm to 4 m.

• Computer-automated testing quickly and accurately guides technicians through test protocol for consistency, accuracy, and unbiased results.

• Optotype precisely calibrated for both distance to subject and pixels-per-inch, strictly following ANSI Z80.21, ISO 8596:2017, ISO 10938, ISO 17979 guidelines regarding size, spacing between optotypes, and spacing between lines.

• Monitor luminance is precisely calibrated utilizing a computer- integrated photometer following FDA guidance. Room luminance is measured and can be programmed to specific luminance conditions as required by the sponsor. Specific environment luminance levels can be programmed into the system which ensures consistency from site to site and visit to visit.

• Mesopic testing at 3 cd/m2 is available by utilizing a neutral density filter.

• Choose Sloan letters (10), British Standard Institution letters (12), Euro-wide letters (12), Tumbling E’s, Landolt C Rings, LEA Symbols®, LEA Numbers®

• Complete randomization of all optotypes, specifically following FDA guidance.

• Expor t test results automatically in an XML or CSV format to any EDC or Reading Center for immediate analysis.

FDA recognized for use in all phases of Clinical Trials, including PMA Trials. Conforms to all ANSI, ISO guidelines for vision testing. CE marked for distribution in the European Union.

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Available Testing Algorithms

Visual Acuity Testing

Visual Acuity Testing

- Intermediate distance 66 cm

- Near distance 40 cm

DCVA - Distance 4 m

DCIVA - Intermediate distance 66 cm

DCNVA - Near distance 40 cm

UCDVA - Distance 4 m

UCIVA - Intermediate distance 66 cm

UCNVA - Near distance 40 cm

LLVA - Low Luminance/Mesopic testing - NDF filter required

High-Res Laptop

Contrast Sensitivity Testing

Contrast Sensitivity Testing

Contrast Acuity - LCVA

Contrast Threshold

Linear Sine Wave Gratings - Testing at 1.5, 3, 6, 12, and 18 cycles-per-degree, Photopic/Mesopic

ACSFS Sinusoidal Bulls Eye - Testing at 1.5, 3, 6, 12, and 18 cycles-per-degree, Photopic/Mesopic - LLCS

Mesopic Testing - NDF filter required

See page 23 for CTS peer-reviewed and published study information

M&S | Clinical Trial Suite CTS 7
Automated
X X BCVA
X X X BCIVA
X
X
X X X
ETDRS
- Distance 4 m
BCNVA
X
X
X
X X
X
X
X X EVA e-ETDRS Electronic Visual
X X X Glare Testing X X Defocus Curve X X MNREAD® X LOW VISION TESTING:
Vision Test X X
Acuity
eLVTTM Electronic Low
X X X
X
X
X
X X
CTS-1500
DVA-5000
System EVA System

Testing Distances - Custom distances available for each platform

Mesopic Testing at 3 cd/m2 available by utilizing an NDF filter

Integrated Photometer: software integration guarantees consistent and repeatable display luminance levels. Also measures room luminance according to sponsor requirements thereby providing consistent luminance levels from site-to-site and visit-to-visit. (not included on EVA System, option for DVA-5000)

Display Background Luminance Automatically Calibrated to FDA Guidance and is ANSI/ISO Compliant

• Calibrated to 85 cd/m2 with certification on brightness, contrast, color temperature - Customized levels from 80 to 320 cd/m2

• Consistent testing display levels from site to site and visit to visit Complaint with ANSI Z80.21, ISO 8596:2017, ISO 10938, ISO 17979

• Infinite randomization of all optotypes (memorization effect eliminated)

• Compliant with FDA Task Force recommendations in regard to infinite randomization of all optotypes (memorization effect eliminated), and target and background luminance levels

• Optotype Distance to Subject

• Optotype Size, spacing between optotypes and lines

• Available: Sloan letters (10), British Standard Institution letters (12), Euro-wide letters (12), Tumbling E’s, Landolt C Rings, LEA Symbols®, LEA Numbers®

Tablet Controller: computer-interfaced tablet provides high-level precision control ensuring outcome accuracy

Error-Free Data Transfer: XML, CSV, PDF - Automatically upload test data results to an EDC, Reading Center, or location of choice

Distance OneTM: Precision measurement device designed to maintain specified testing distances

FDA recognized for use in all phases of Clinical Trials, including PMA Trials. Conforms to all ANSI, ISO guidelines for vision testing. CE marked for distribution in the European Union.

FDA recognized for use in all phases of Clinical Trials

Conforms to all ANSI ISO guidelines for vision testing

28 cm - 66 cm 40 cm - 4 m 2.5 m - 4 m CTS-1500 High-Resolution Laptop 5.5" Ultra-High Resolution Display EVA System DVA-5000 System 2.5 m - 4 m ®
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The computerized EVA system is exclusively manufactured and distributed by M&S Technologies

EVA e-ETDRS

Electronic Visual Acuity System

• Configured to use e-ETDRS or AST Protocols

• Conforms to all ANSI and FDA guidelines for vision testing

• For Contrast Sensitivity testing, the symbol sets can be displayed at varying levels of contrast (2.5%, 5%, 10%, 25%)

• Monitor calibration set to ANSI, ISO specifications and FDA recommendations of 85 cd/m2 for visual acuity testing

• Utilizes an infinite number of chart randomizations

• Multiple hardware configurations

• Significantly reduces data collection expense

• CE marked for distribution to the EU

Tablet controlled data-entry for seamless integration

Symbol Sets Available

Any symbol set can be selected and inserted into the EVA protocol to accommodate international investigator sites

• Sloan Letters

• British Standard Institutional Letters

• Euro-Wide Letter Set

• Landolt C Rings

• Numbers

• Tumbling E

• LEA Symbols®

• HOTV

To accommodate international investigator sites, any symbol set can be selected and inserted into the EVA protocol.

See page 23 for CTS peer-reviewed and published study information

9 M&S | Clinical Trial Suite CTS

Defocus Curve

Automates Defocus ETDRS testing from the standard +2.0 diopters through -5.0

Customizable to sponsor requirements

• Defocus Curve automates ETDRS testing from the standard + 2.0 diopters through - 5.0 and is customizable to study specifications

• System calibration is set in meters at virtually any distance and is adjustable and precise

• Choose Sloan letters (10), British Standard Institution letters (12), Euro-wide letters (12), Tumbling E, Landolt C Rings, LEA Symbols, and Number

• Standardized background luminance is set to 85 cd/2m as recommended by the FDA (ANSI/ISO) and can be customized from 80 to 320 cd/m2 to fit any luminance levels for a study

• Optotypes are precisely calibrated for both distance-to-subject and pixels per-inch, strictly following ISO guidelines regarding size, spacing between optotypes and spacing between lines.

FDA recognized for use in all phases of Clinical Trials, including PMA Trials. Conforms to all ANSI, ISO guidelines for vision testing. CE marked for distribution in the European Union.

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DEFOCUS CURVE GRAPH Test Complete Press “Finish” on tablet (“END” on keyboard) for Main Menu Letters Contrast LogMAR diopters 100 95 90 85 80 75 70 65 60 55 50 45 40 35 30 -2.0 +1.5 +1.0 +1.5 0.0 -0.5 -0.1 -1.5 -2.0 -2.5 -3.0 -3.5 -4.0 -4.6 -5.0 (20/18) -0.3 (20/12) -.0.2 (20/25) -0.1 (20/75) 0.0 (20/100) 0.1 (20/125) 0.2 (20/125) 0.3 (20/125) 0.4 (20/125) 0.5 (20/150) 0.6 (20/175) 0.7 (20/180) 0.8 (20/200) 0.9 (20/230) 1.0 (20/250) 1.1 • • • • • • • •

Contrast Acuity

• Contrast Acuity Testing eliminates technician bias, calculation errors, and erroneous test results

• Memorization Effect is eliminated with an infinite number of computer randomized optotype, letter, and shape presentations ensuring consistent, repeatable and unbiased test results

• Standardized, background luminance is set to 85 cd/m2 as recommended by the FDA (ANSI/ISO)

• Mesopic testing at 3 cd/m2 is available by utilizing a neutral density filter

• Letter-contrast luminance as well as environmental room conditions are automatically calibrated and measured which allows for consistent shades of gray from site to site and visit to visit

• System calibration is set in meters at virtually any distance and is adjustable and precise

• Optotypes are precisely calibrated for both distance-to-subject and pixels-per-inch, strictly following ANSI Z80.21-2010 (R2015), ISO 8596:2017, and ISO 10938 guidelines regarding size, spacing between optotypes, and spacing between lines

• Expor t test results automatically in an XML or CSV format to any EDC or Reading Center for immediate access to statistical analysis - Results indicate ETDRS numerical score, contrast acuity level, and logMAR value

Results indicate:

- Contrast Acuity Level

- E TDRS Numerial Score

- LogMAR Value

Contrast Threshold

FIXED -SIZED letters are displayed at 20/100 size, and a 10% contrast level and will decrease by -0.1 log units until threshold is achieved

All luminance, sizing, calibration, and exportation of test results are consistent with all other testing algorithms within CTS

Results indicate:

- Contrast Acuity Level

- LogMAR Value

4m

Best Correction Light Level: Mesopic

4.6%

Score: 72

M&S | Clinical Trial Suite CTS
See
23 for CTS peer-reviewed and published study information Contrast Results Eye: Both Eyes Distance: 4m Correction: Best Correction Light Level: Mesopic Contrast: 4.6% Logmar: -1.34 Score: 72
Distance:
page
Contrast Results Eye: Both Eyes
Correction:
Contrast:
Logmar: -1.34
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Automated Contrast Sensitivity Function System (ACSFS)

Sinusoidal Bullseye

Testing

• Contrast levels start at 0.3 log units above normative data, allowing for expedited test time

• Conduct testing at 1.5, 3, 6, 12 and 18 cycles-per-degree at either photopic or mesopic luminance levels

• Average initial test time is less than 5 minutes per eye, followed by 2-3 minutes for existing subjects by starting at 0.3 log units above previously stored values

• Designed with the maximum response time to eliminate the focusing effect. Predetermined screen blanking time, allows the retina to refresh between displays

• Complies with FDA Task Force recommendations of target and background luminance levels

• Background luminance is standardized and calibrated to 85 cd/m2 to comply with ANSI and ISO testing. Certification on brightness, contrast and color temperature

• Eliminate patient bias with randomly presented optotypes that are not affected by higher order aberrations such as residual astigmatism, coma, trefoil, etc.

• Replaces biased testing methods for with-the-rule aberrations such as vertical astigmatism, vertical coma, and biased against aberrations such as against-the-rule and horizontal coma

• Test results compared to normative data and defined area under the curve

controller eliminates all manual calculations, technician error and bias

FDA recognized for use in all phases of Clinical Trials, including PMA Trials. Conforms to all ANSI, ISO guidelines for vision testing. CE marked for distribution in the European Union.

®
Average test-time is less then 5 minutes per eye
Tablet
12

Average test-time is less then 4 minutes per eye

Linear Sine Wave Grating

• Conduct Contrast Sensitivity Function testing at 1.5, 3, 6, 12, and 18 cycles-per-degree at either photopic or mesopic luminance levels

• Contrast levels start at 0.6 log units above normative data allowing for expedited test time

• Complies with FDA Task Force recommendations of target and background luminance levels

• Background luminance is standardized and calibrated to 85 cd/m2 to comply with ANSI and ISO testing, with certification on brightness, contrast and color temperature Mesopic testing at 3 cd/m2 is available by utilizing a neutral density filter

• Randomized presentations are precisely calibrated for both distance-to-subject and pixels-per-inch - Utilizes an infinite number of chart randomizations

• Test results can be automatically exported in an XML or CSV format to any EDC or Reading Center providing immediate access for statistical analysis

• System is fully customizable to accommodate any study requirements

• Conforms to all ANSI, ISO and FDA guidelines for vision testing

Tablet controller eliminates all manual calculations, technician error and bias

M&S | Clinical Trial Suite CTS
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Glare Testing System (GTS)

• Consistent luminance at required FDA testing distances

• Test with Contrast Sensitivity and Visual Acuity

Glare Testing System (GTS)

• Can be used at both Photopic and Mesopic luminance levels

• Used with any letter or symbol set available

• Easy to install and utilizes long-life, high intensity LED’s

• Virtually maintenance free

• GTS delivers repeatable results to effectively evaluate the effect of glare on contrast sensitivity and visual acuity

• Glare Testing System complies with the FDA task force recommendations on reducing the contrast function by .1+ log units across more than one cycle per degree without without washing out the subjects vision

• Proprietary lenses minimize the “light spray”, starburst and halo effects typically associated with conventional glare testing methods

• Test with Contrast Sensitivity and Visual Acuity

• Can be used at both Photopic and Mesopic luminance levels

• Long-life, high-intensity LEDs rated at 50,000 hours

• Consistent luminance at required FDA testing distances

• Patented technology allows for an equal amount of light to be dispersed over the surface of the eye for balanced luminance distribution. Peer review and publication(s) available for review

M&S Glare Testing System delivers consistent, repeatable results to effectively evaluate the effect of glare on contrast sensitivity and visual acuity

®
Tested and validated according to FDA regulation 21 CFR part 11, CFR part 820r and strictly adheres to ANSI & ISO standards.
mstech-eyes.com 1-877-225-6101 1-847-763-0500 Software development in USA ©2022 M&S and Smart System are registered trademarks of the Hilsinger Company Parent LLC. All rights reserved. The Hilsinger Company Parent LLC holds US Patents 7,354,155; 7,926,948; 8,425,040; 8,167,429; 8,419,184; 8,550,631; 8,992,022; 9,433,347; 9,820,644; 10,244,938 and 10,182,713. Other Patents Pending.
Close-up of single LED light
FDA recognized for use in all phases of Clinical Trials, including PMA Trials. Conforms to all ANSI, ISO guidelines for vision testing. CE marked for distribution in the European Union. 14
The First Choice in Vision Testing Systems

For the ultimate near vision testing experience

5.5" Ultra High-Resolution Display

High-resolution display for ultra-sharp optotypes

• Precision display of letters/symbols at near and intermediate testing distances

• Customized test distances from 66 cm to 28 cm

• Fully automated testing algorithm for both ETDRS and Contrast Sensitivity

• Seamless integration into Clinical Trial Suite

• Allows for testing down to 28 cm with clear optotypes

• Small footprint compared against ETDRS near charts

• Add the Distance OneTM measurement device to maintain precise display-to-subject distance

See page 23 for CTS peer-reviewed and published study information

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5.5
M&S | Clinical Trial Suite CTS
"
Tablet Controller ULTRA HD

Precision measurement device designed to maintain specified testing distances

• Ultrasonic distance detection accurately measures and maintains specified calibration distance from LED display-to-subject

• Sponsor can set the range of calibration distance

• Auto-Motion Detection will pause the test while notifying the technician based on participant deviation in distance to LED display

• Seamless integration with all CTS systems for both near, intermediate, and other customizable testing distances

FDA recognized for use in all phases of Clinical Trials, including PMA Trials. Conforms to all ANSI, ISO guidelines for vision testing. CE marked for distribution in the European Union.

Auto-Motion Detection pauses testing to notify technician of distance deviation

Distance
®
One™
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Eliminates:

• Manual Calculations

• Technician Error and Bias

Tablet Controller

Tablet controlled data-entry for the most accurate results

• Select subject responses on Tablet and confirm to verify

• Easy-to-follow instructions allow for more accurate and efficient testing

• Computerized testing with rapid tablet data entry reduces test time and improves accuracy

• The CTS tablet provides a high level of precision and repeatability from site-to-site and visit-to-visit

See page 23 for CTS peer-reviewed and published study information

17 M&S | Clinical Trial Suite CTS
Number of correct letters RETINA: Select correct letters only Select easiest line to read Sinusoidal Bullseye Linear Sine Wave Gratings

Luminance Sensor (Photometer)

Trusted, consistent, and repeatable luminance levels from site-to-site and visit-to-visit

• In accordance with FDA recommendations, the software-integrated photometer measures and calibrates background monitor luminance to 85 cd/m2 for brightness, contrast, and color temperature

• Luminance levels are certified, standardized, and compliant with ANSI and ISO standards

• Monitor luminance level can be customized and programmed from 80 to 320 cd/m2 to accommodate any trial requirements

• Room luminance levels can be customized to sponsor requirements

• The photometer ensures that room luminance is consistent. Testing will not be permitted if the level exceeds the sponsor requirement

Provides consistent luminance at required testing distances

All target and background luminance levels comply with FDA Task Force recommendations

FDA recognized for use in all phases of Clinical Trials, including PMA Trials. Conforms to all ANSI, ISO guidelines for vision testing. CE marked for distribution in the European Union.

18 ®

Web-Based Vision Testing

• Tests include: e-ETDRS, ATS/HOTV and screening protocols

• Convenient web-based testing on any computer or tablet

• Maintain regular status of patient’s vision

• Use for long-term and post-study observation

• Results are securely transmitted and stored on HIPAA compliant server

• Selected at-home tests reduce the costs associated with travel time to testing sites

• Remote pediatric participation is increased with flexible testing that does not impact school schedules

• Optional live technician observation

Web-based remote testing can substantially improve enrollment rates, retention, and engagement

See page 23 for CTS peer-reviewed and published study information

M&S | Clinical Trial Suite CTS • • • • • • • • • • • •
Straightforward
19
and Secure

eLVTTM Electronic Low Vision Test

The eLVT™ system eliminates counting fingers (CF) and hand motion detection (HM) for vision assessment to provide visual thresholds of low vision subjects with accuracy and repeatability

• Accurately determine VA levels greater than 20/10,000

• Test at 3 meters, 1 meter and 25 centimeters with proprietary technology

• Test targets include Sloan letters, Tumbling E’s, black with white gratings and black & white discrimination

NO
NO
NO
® 20
Hand Motion
Finger Detection
Bias

LETTERS

SYMBOLS

NUMBERS

Precisely calibrated optotypes for all testing algorithms

• Optotypes are precisely calibrated for both distance-to-subject and pixels-per inch

• Strictly follows ANSI 280.21-2010 (R2015), ISO 8596:2017, & ISO 10938 guidelines regarding size & spacing between optotypes, and spacing between lines

• FULLY RANDOMIZED utilizing an infinite number of chart randomizations to eliminate memorization effect.

• Any symbol set can be selected and inserted to accommodate international investigator sites

• For Contrast Sensitivity testing, these symbol sets can be displayed at varying levels of contrast (2.5%, 5%, 10%, 25%)

Symbol Sets Available

Sloan Letterset Landolt C’s Tumbling E’s LEA Symbols® LEA Numbers® M&S | Clinical Trial Suite CTS
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Professional Training

Comprehensive Training for World-wide Investigator Sites

• Training includes equipment installation, site certification, luminance validation, and technical training

• Certification of all technicians responsible for testing subjects

• Follow-up re-certification available

Superior Technical Support

The best service in the industry for over 30 years

“Spare-in-the-Air” Replacement Warranty Program assures replacement hardware within 24 hours (International delivery times vary)

Includes: Instant access to our technical support team 24/7, software warranty, and each trial assigned a dedicated CTS Technical and Administrative Specialist to manage study protocols and implementation

FDA recognized for use in all phases of Clinical Trials, including PMA Trials. Conforms to all ANSI, ISO guidelines for vision testing. CE marked for distribution in the European Union.

24/7 Worldwide Technical Support

®
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Validated Published Studies

Beck RW, Moke PS, Turpin AH, et al. A computerized method of visual acuity testing: adaptation of the early treatment of diabetic retinopathy study testing protocol. Am J Ophthalmol. 2003;135(2):194-205. doi:10.1016/s0002-9394(02)01825-1

Khanani AM, Brown SM, Xu KT. Normal values for a clinical test of letter-recognition contrast thresholds. J Cataract Refract Surg. 2004;30(11):2377-2382. doi:10.1016/j.jcrs.2004.05.027

McClenaghan N, Kimura A, Stark LR. An evaluation of the M&S technologies smart system II for visual acuity measurement in young visually-normal adults. Optom Vis Sci. 2007;84(3): 218-223. doi:10.1097/ OPX.0b013e3180339f30

van Gaalen, Kim W. MSc ; Jansonius, Nomdo M. MD, PhD; Koopmans, Steven A. MD, PhD; Terwee, Thom MSc; Kooijman, Aart C. PhD. Relationship between contrast sensitivity and spherical aberration: Comparison of 7 contrast sensitivity tests with natural and artificial pupils in healthy eyes. Journal of Cataract & Refractive Surgery: January 2009 - Volume 35 - Issue 1 - p 47-56 doi: 10.1016/ j.jcrs.2008.09.016

Chandrakumar M, Colpa L, Reginald YA, Goltz HC, Wong AM. Measuring contrast sensitivity using the M&S Smart System II versus the Pelli-Robson chart. Ophthalmology. 2013;120(10):2160-1.e1. doi:10.1016/j.ophtha.2013.07.022

Sanjeev Kasthurirangan, Carrie Garufis, Jay Rudd, Jonathan Solomon. Evaluation of an Electronic Visual Acuity and Contrast Sensitivity Test System for Use in Ophthalmic Clinical Trials. Invest. Ophthalmol. Vis. Sci. 2017;58(8):4229. POSTER

Liu JL, McAnany JJ, Wilensky JT, Aref AA, Vajaranant TS. M&S Smart System Contrast Sensitivity Measurements Compared With Standard Visual Function Measurements in Primary Open-Angle Glaucoma Patients. J Glaucoma. 2017;26(6):528-533. doi:10.1097/IJG.0000000000000659

Harris PA, Roberts LE, Grant R. Comparison of backlit and novel automated ETDRS visual acuity charts. Optom Vis Perf 2018;6(2):87-96. http://www.ovpjournal.org/uploads/2/3/8/9/23898265/ backlit.pdf

Harris PA, German Z, Roberts L. Normal values for mesopic and photopic contrast sensitivity function with and without glare using a sinusoidal bull’s-eye target. Optom Vis Perf 2019;7(3):138-48.

Yi Pang, Lauren Sparschu & Elyse Nylin (2020) Validation of an automated‐ETDRS near and intermediate visual acuity measurement, Clinical and Experimental Optometry. 103:5, 663-667, DOI: 10.1111/ cxo.13018

Pang Y, Sparschu L, Nylin E, Wang J. Validation of an Automated Early Treatment Diabetic Retinopathy Study Low-contrast Letter Acuity Test. Optom Vis Sci. 2020;97(5):370-376. doi:10.1097/ OPX.0000000000001506

Pang Y, Sparschu L, Wang J. Repeatability of an automated ETDRS contrast threshold measurement. Ophthalmic Physiol Opt. 2021;41(4):896-899. doi:10.1111/opo.12829

M&S | Clinical Trial Suite CTS
23 The First Choice in Vision Testing Systems
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