SOW_OptosCalifornia_200TDx_13MAR2020.docx

Statement of Work for the Two Optos California Ultra-Widefield Retinal Imaging System200DTx FA Prepared by Denise Cunningham, MS, Med, FOPS on March 13, 2020

1.1 BACKGROUND

The Imaging Services Section provides visual data for the ophthalmology investigators working in the Eye Clinic of the National Eye Institute (NEI) in support if the clinical Intramural Research Program (NEI-IRP), at the National Institutes of Health. An instrument used in a multitude of NEI studies, since 2012, is the Optos 200Tx Ultra-Widefield (UWF) Retinal Imaging System. In order to meet the demands of the NEI-IRP studies, the institute has two of these older devices and a newer Optos California 200TDx.

The Optos 200Tx instruments have reached their End-of-Life (EOL), effective December 31, 2020, and the vendor will no longer service and support the maintenance of these valuable devices (Attachment). To maintain the integrity of the research and support the volume of research subjects undergoing Optos imaging, it is necessary and imperative that these EOL devices be replaced.

1.2 PURPOSE

The reasons for obtaining two Optos California Ultra-Widefield Retinal Imaging System200DTx are based on the unique characteristics of the instrument, which are listed below:

· Only instrument compatible with our EOL Optos devices and imaging system platform

· Only instrument that will provide exact and precise follow-up on NEI research images taken since 2012

· Only technology that can produce a 200° single-capture retinal image

· Only technology that can capture a single retinal image in less than ½ second

· Provides non-mydriatic (undilated) imaging of the retina

· Presents images in a consistent geometry that accurately represents anatomy across the retina

· Enables pixel to pixel automatic image registration

· Allows comparisons of images across modalities and from visit to visit

· Scanning laser technology for imaging through most cataracts and small pupils (2 mm)

· Provides important clinical data from the retinal surface through the choroid.

· Minimizes patient light exposure with green laser autofluorescence

· Shows macula and optic nerve head detail with various wavelengths

· Offers browser-based HIPAA-compliant image review

· Provides access to data from any connected pc or tablet

· Provides distance (mm) and area (mm2) measurements for objective assessment of change over time

· Allows assessment of the optic nerve with stereoscopic disc imaging to diagnose and follow the progression of glaucoma

· Combines an image series into a single image showing up to 220° (97%) of the retina

· May be used as an investigational device when performing research with institutional review board (IRB) oversight

1.3 ANTICIPATED BENEFITS

Replacing our End-of-Life devices with two Optos California 200DTx Ultra-Widefield Retinal Imaging Systems will ensure that the NEI IRP clinician investigators’ research will be maintained. The following 20+ NEI research studies currently utilize the Optos EOL devices that must be replaced:

20-EI-0004: Adalimumab vs. Conventional Immunosuppression for Uveitis (ADVISE) Trial 19-EI-0056: A Survey Study of Retinitis Pigmentosa (RP) Clinical Measures and Repeatability Testing of Potential Outcome Measures 19-EI-0045: A Sub-Study to the Extension Study of NT-501 Ciliary Neurotrophic Factor (CNTF) Implant for Macular Telangiectasia (MacTel) (NTMT-01/02E) to Provide the Renexus Implant to Participants who Contributed a Single Eye Randomized to the Sham Procedure in the 18-EI-0142: A Phase 2, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Filgotinib in Subjects with Active Non-Infectious Uveitis 17-EI-0112: A Long-term Follow-up Study of Participants Enrolled in 11-EI-0147: Longitudinal Investigation of Dark Adaptation in Participants with Age-Related Macular Degeneration (DA_AMD) 17-EI-0071: Age-related Macular Degeneration (AMD) Ryan Initiative Study 16-EI-0159: A Phase I/II Trial for Intravitreous Treatment of Severe Ocular von Hippel-Lindau Disease Using a Combination of the PDGF Antagonist E10030 and the VEGF Antagonist Ranibizumab 16-EI-0169: A Pilot Study to Investigate Ustekinumab for the Treatment of Active Sight-Threatening Uveitis 16-EI-0090: Natural History of Spinocerebellar Ataxia Type 7 (SCA7) 16-EI-0046: Uveitis/Intraocular Inflammatory Disease Biobank (iBank) 15-EI-0128: The Genetics of Inherited Eye Disease 15-EI-0038: A Phase I/IIa Study of RS1 Ocular Gene Transfer for X-linked Retinoschisis 13-EI-0049: Genetics of Uveal Coloboma 12-EI-0203: Natural History of ABCA4-Related Retinopathies 12-EI-0042: NEI Intramural Biorepository for Retinal Diseases 11-EI-0245: Generation of Induced Pluripotent Stem (iPS) Cell Lines from Somatic Cells of Participants with Eye Diseases and from Somatic Cells of Matched Controls 11-EI-0147: Longitudinal Investigation of Dark Adaptation in Participants with Age-Related Macular Degeneration 11-EI-0264: A Pilot Study for the Evaluation of Minocycline as a Microglia Inhibitor in the Treatment of Central Retinal Vein Occlusions 11-EI-0263: A Pilot Study for the Evaluation of Minocycline as a Microglia Inhibitor in the Treatment of Branch Retinal Vein Occlusions 10-EI-0140: Genotype-Phenotype Study of Patients with Plaquenil -Induced Retinal Toxicity 03-EI-0033: X-Linked Juvenile Retinoschisis - Clinical and Molecular Studies

1.4 SOFTWARE OR TECHNOLOGY PRODUCTS PROPOSED

The newer Optos California 200DTx Ultra-Widefield Retinal Imaging Systems are compatible with the current software platform, Optos Advance.

1.5 BUSINESS PROCESSES IMPACTED

The small footprint of the newer Optos devices will free up some much-needed space in the clinic. Otherwise, no major changes will occur in the way that business will be conducted, once the new Optos California 200DTx Ultra-Widefield Retinal Imaging devices are installed.

1.6 CUSTOMERS / END USERS IMPACTED

Because of its small footprint and speedy capture time, research subjects, principal investigators, and ophthalmic photographers will all be positively affected by the addition and incorporation of the Optos California 200DTx UWF units into the workflow. The integrity of the National Institutes of Health’s clinical research imaging will be maintained.

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