Header of section Validation Document EyeCare Screening & Detection Solve and scale unsolved problems

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Internal | RBIN/BUD RBEI/BUD | 14/08/2014 | © Bosch Limited 2014. All rights reserved, also regarding any disposal, exploitation, reproduction, editing, distribution, as well as in the event of applications for industrial property rights.

Header of section

Validation Document

EyeCare Screening & Detection

Solve and scale unsolved problems

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References:

Multiple studies have been conducted globally to aid qualification &

acceptance of the product including FDA & CE certifications for the

underlying platform

Disclaimer:

The studies & references herewith mentioned are not necessarily for the

current version of Bosch handheld device and may include feedback on

previous versions of the platform

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STUDY-1

Sample images comparison with canon CR-DGi. Picture material

courtesy Dr P Bonnet

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Sample images with Bosch Handheld and Other

Camera

Canon CR-DGi

Bosch Handheld

Glaucoma and Cataract

Macular degeneration and cataract

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Sample images with Bosch Handheld and Other

Camera

Canon CR-DGi

Bosch

Glaucoma and Cataract

Optic nerve hemorrhage (early stage of glaucoma)

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Sample images with Bosch Handheld and Other

Camera

Canon CR-DGi

Bosch Handheld

Optic nerve superior fiber defect (early stage of glaucoma)

Diabetic retinopathy – early stage

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Sample images with Bosch Handheld and Other

Camera

Canon CR-DGi

Bosch Handheld

Diabetic retinopathy – advanced stage

Macular Drusen – early stage of macular degeneration

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Sample images with Bosch Handheld and Other

Camera

Canon CR-DGi

Bosch Handheld

Cataract – patient over 75 yrs

Advanced glaucoma

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Sample images with Bosch Handheld and Other

Camera

Bosch Handheld

Optic nerve edema

Choroidal melanoma

Toxoplasmic scar

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STUDY-2

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Impressions of the Handheld Non Mydriatic Fundus

Digital Imaging Device - Kenneth R. Mueller, OD

“The new hand-held wireless cameras, weighing in at only one pound, has found a home in our busy practice over the past year. Here is why you may want to give it a look.

The hand held device is a small, surprisingly affordable, high-tech camera with excellent image quality. It is quick and easy to use, is very portable and takes nice, reflection free anterior and posterior images. Cobalt blue light can be used for anterior shots for use with fluorescein dye. Hand held fundus camera features include auto and manual focus, zoom, plus and minus 20 diopter range, infra-red focusing, infra-red and white light images, simultaneous red-free images, and a 40 degree fundus view. Images are stored in the device in standard jpeg format and can be easily downloaded to computer or into many EMR software programs by simply placing the unit onto its base.

In our practice, the hand held fundus camera is highly valued in several different situations. We utilize the hand held fundus camera for imaging patients with limited mobility-for instance, supine and obese patients for whom our standard fundus camera does not work. It is excellent for our babies and very small children who, likewise, are ill-suited to our standard fundus camera. The device is invaluable for nursing home and hospital visits, and has proved quite handy on screenings and mission trips. Smaller satellite offices without room or budget for a large stationary fundus camera would also be an excellent fit.

The device is a quick and easy-to-use camera with excellent image quality. It has been completely reliable, is loaded with features, and would be an excellent value for many practice situations.

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STUDY-3

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Testimonial- Bosch Handheld Fundus Camera

I have a large paediatric and adolescent diabetes practice of over 1000 patients and see between 4 and 15 per day. We have a doctor and a diabetes educator doing routine annual diabetes eye screening.

We found the camera easy to use and train on. The pictures we get are more than adequate for diabetic eye screening and allow for repeat testing and comparison over time.

The children ranging from 6 years of age to late teens are able to co-operate with the testing requirements and obtaining decent quality images is not difficult.

My overall assessment is very positive having done extensive side by side comparisons with the competitor products and I do not regret my choice.

Regards

Dr David Segal

Paediatric Endocrinologist

WITS DonaldGordon Medical Centre

Parktown

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STUDY-4

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Testimonial – Bosch Handheld Fundus Camera

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In my optometry practice of over 30 years, I had been missing the ability to provide digital images for fundus & eye-surface. Main reasons for not having introduced digital-imaging facility so far in my clinic were:

1. Space available in office

2. Barriers to learning the required skills

3. Consideration of extra chair-time to be spent on this procedure 4. Barrier towards dilation of pupils

5. Cost and break-even time

All the points listed above and much more was addressed in very simple way. a) Space: This instrument can fit into drawers of clinic

b) New skill set : After a few minutes of instructions, I could click very good images of eye-surface and fundus

c) Extra chair time: It takes less than one minute for each eye to have quality images. We went a step ahead and acquired a stand-alone photo printer. From in-to-out time for a patient, within 10 to 15 minutes the eyes are imaged and patient walks away with printed photographs.

d) Dilation: This is non-mydriatic camera and does not need dilation. Covers upto 40 degrees of retina.

e) We have been able to break-even our initial investment in just 1 year by doing only 3 patients per working day.

I am very satisfied with this instrument and recommend that in countries like India, where the optometrist does not dilate pupils, funds are limited, office-space is less and professional-will to upgrade is high, this instrument is a boon.

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Testimonial - Bosch Handheld Fundus Camera

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Among other applications, this camera is portable and therefore images can be clicked at patient’s home. Images can be clicked whether patient is sitting or lying down. In eye-camps and in physicians’ diabetic camps, several patients can be imaged during the event and then images can be analyzed by experts later. Each patient can be assigned different folder number. Once charged, the battery lasts for about 40 to 50 patients.

With blue-light feature, fluorescein patterns of tricky fits can be imaged. We can use this in keratoconus fitting and scleral lens fitting to seek opinion from peer group.

The images clicked by this digital camera can be zoomed and edited. These can also be emailed anywhere for opinion. Images can be compared over an interval when clicked at different times. We found this camera very useful in cases of RGP contact lens fitting, diabetic retinopathy, hypertensive retinopathy, glaucoma and several other conditions. We have slit-lamps in our clinics as a professional necessity. I am hopeful that soon such instruments will also become equally important in optometry setups.

Rajesh Wadhawa

Consultant Optometrist, Orthoptist

Contact Lens Specialist

Wadhwa Optikos,

Delhi

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STUDY-5

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Testimonial – Statement for Bosch Handheld

Fundus Camera

Patients who have been examined consists of children aged between 3 months and 18 years with different optic nerve and macular diseases.

Based on my usage experience:

The overall quality of the product is good

Image quality is good enough for documentation Ease of use is satisfactory

Suitability for screening and diagnosing optic nerve and macular diseases is good Suitability for follow-up and remote consultation purposes is good

Name: Anna Majandar

Title: Ophthalmologist, MD, PhD

Organization: Helsinki University Central Hospital, Paediatric Ophthalmology Unit Signature:

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STUDY-6

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Testimonial – Statement for Bosch Handheld

Fundus Camera

Based on my experience:

• The overall quality of the product is good. I know that there are many more fancy cameras available, but considering the prices I have seen, I think this camera is an excellent value

• Image quality is sufficient for my purpose, which have involved emailing of fundus photos to retina specialists in several distant locations

• Ease of use is one of the main benefits of this camera. I just picked it up and started using it immediately. Downloading images to the computer was no different than with any digital camera. I got decent pictures of the very first patients I imaged and whatever learning curve I experience was minutes, and not hours.

• Another benefit that this camera takes very little space which is a big advantage for us because we really do not have space to dedicate to a camera that requires its own table.

It has certainly been helpful in my practice, and I really like that it requires a lower overhead compared to other cameras both in purchase price and floor price.

Name: Michael Seward, MD Title: Ophthalmologist

Organization: CBM, Papua New Guinea Signature:

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STUDY-7

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Testimonial – Statement for Bosch Handheld Device

It is an easy to use device for medical units of all sizes, can be used in primary care as well as at an ophthalmologist's or optometrist’s office.

The modular size makes it easy to carry along and even use it in remote locations. Connecting the camera to a PC and downloading images is effortless and does not require IT know-how.

The device is suitable for screening purposes for diseases such as diabetic retinopathy and AMD. ES1 optics module gives extra added value to the product with the ability to take pictures and video of the exterior parts of the eye with both white and blue illumination

Professor Alvydas Paunksnis

Eye clinic of Lithuanian University of Health Sciences, Head, Telemedicine Centre

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STUDY-8

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Testimonial- Statement for Bosch Handheld Device

The prime benefits of this instrument are:

• Low weight and portability makes it easy to carry for camps and also ensures a tireless examination of the patients

• The non mydiratic imaging is of definite advantage when examining a glaucoma patient.

• The red free imaging enables good visualization of the nerve fibre layer and is an added pearl for glaucoma diagnosis

• For neuro-ophthalmology, non-mydriatic imaging enables preservation of pupillary signs and red free imaging enables nerve fibre bundle defect detection

• While using for diabetic screening, the device has the ability to take large field of view at high resolution and post processing and magnification of the images, to be of value. Even single microaneurysmscan be observed and diagnosis can be reached at with certainty. Following up such patients is also easy with the PC software provided to store sequential images,

• It is a beneficial tool as it enables quick single click fundus photography and is its manoeuvrability makes it simple to take photographs in a slightly uncooperative child or child under general anaesthesia.

Dr. Digvijay Singh

MBBS, MD (AIIMS) Senior Resident

Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences,

Ansari Nagar, New Delhi – 110029

Telephone: 011- 26593185, +91-9811664647 [email protected]

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STUDY-9

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A randomized study to compare the efficacy of a hand held portable non

mydriatic fundus camera with a non portable non mydriatic fundus camera in

diagnosing Diabetic Retinopathy in an urban slum population

AUTHORS/INSTITUTIONS: A. Rogye, S. Mohan, A. Sivaram, R. Srinivasan, S. Natarajan, Ophthalmology, Aditya Jyot Foundation for Twinkling Little Eyes, Mumbai, Maharashtra, INDIA; A. Rogye, S. Mohan, A. Sivaram, R. Srinivasan, S. Natarajan, Ophthalmology, Aditya Jyot Eye Hospital Pvt. Ltd., Mumbai, Maharashtra, INDIA;

ABSTRACT BODY:

Purpose: This study was done to find if the new portable hand held camera could be used as a screening device for the detection of Diabetic Retinopathy in the urban slum population of Mumbai.

Methods: 150 eyes of 75 patients underwent dilated retinal examination to screen for the presence of Diabetic Retinopathy among the Diabetic population in the slums of Mumbai.

Comparison was made between the images obtained using the non mydriatic non portable Visucam 500 fundus camera(Carl Zeiss, Germany) and the non mydriatic portable hand held camera

Photographs were taken on both the handheld camera, and the Visucam 500 camera, Zeiss, by the same examiner and transferred to a computer. These images were later assessed by 2 examiners.

Results: Kappa values of correlation of agreement in the diagnosis and grading between the examiners was 0.85.

Of the 31cases of Diabetic Retinopathy, 19 eyes were diagnosed with early retinopathy changes, of which 8 were missed on the Handheld portable camera, but were detected on the Zeiss non portable device.

10 eyes were found to have advanced NPDR and PDR which were easily detected on both instruments.

2 eyes were found to have retinopathy changes which could not be conclusively graded due to media opacities using either instrument. Hence the handheld camera showed a sensitivity of 70% in detecting early retinopathy change in diabetic patients as opposed to 100% sensitivity of the Zeiss non portable device in eyes with minimal media opacities.

Both devices showed equal sensitivity to detect advanced retinopathy changes in diabetic retinopathy.

Conclusions: We concluded that the handheld non mydriatic fundus camera can be used as a screening device for the detection of Diabetic Retinopathy in remote areas, due to its portability and good sensitivity.

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STUDY-10

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Use Of Non-mydriatic Cameras For Diabetic Retinopathy Screening In Community-based Settings, Centre for Eye Research Australia, Melbourne, Australia & Radboud University Nijmegen Medical Centre, The Netherlands

AUTHORS/INSTITUTIONS: Anke Lenferink, Health Technology Assessment Centre for Eye Research Australia, Melbourne, Australia Radboud University Nijmegen Medical Centre, The Netherlands

ABSTRACT BODY:

Purpose: These recommendations are written in order to choose a suitable non‐mydriatic camera (NMC) for diabetic retinopathy (DR) screening in community‐based settings. There is also a ranking made for seven cameras which include both a non‐mydriatic as well as a fluorescein angiography function. This function is a pre‐requisite for laser treatment, but not necessary in DR screening.

• The cameras were ranked for their portability, field‐readiness,

ease of use, and performance. The costs were also taken into account. The portability depended on the weight to take it away and facilitate handling. It was divided into four categories to rank the NMCs for portability (‘+’ ≥ 30kg; ‘++’ 20‐30 kg; ‘+++’ 10‐20 kg; ‘++++’ <10 kg). Other requirements to consider are transport and survival of long road trips, training, duration of the screening project, maintenance, software provided, database, equipment, and instructions or a manual.

• A NMC needed to perform quick imaging, screen a high

patient number and be time‐efficient and comfortable for

patients. Performance was dependent on the image quality of captured images on the camera monitor or the PC monitor. Image quality consisted of (a) image clarity, because there is a need to give sufficient detail for retinopathy grading; and (b) adequate field definition, which shows the desired field of view for retinopathy grading (disc and macula). An indicator can be the visibility of macular vessels.

Recommendations Non Mydriatic Camera:

The Handheld camera (Bosch Platform), DRS, & VI-NM1, were found to be the most suitable cmaera’s to screen for DR in community based settings.