Attachment_1_Statement_of_Work-amended.pdf

Optical Microscope

Endothelial Layer Imaging

Statement of Work

Project Title: All-in-one Specular Microscope

Document Date: 18 April 2018

Objective: USAFSAM FECO requires a device to be used for candidate evaluation for flight and post-operative endothelial cell count/density/posterior corneal eye health.

Scope: To give the ophthalmologist a device that can measure endothelial cells for aviators and aviation candidates. This is not a research device, but will be used in conjunction with management groups that are followed if the tested aviator is found to have a defect that requires treatment. USAFSAM FECO requires a specular microscope that can obtain imaging of the entire endothelial layer of the cornea.

Background: The FDA approved a device in 2017 that is used to treat keratoconus (corneal degenerative disease), but in order to have that procedure accomplished, the Optical Microscope is required before and after surgery to measure endothelial cells. Due to the UV exposure that is required to make the procedure work, endothelial cells will be lost, and this is the only device on the market we can use to get an accurate pre/post op measurement of how much of an effect the procedure had on the posterior of the cornea. Without this device we cannot complete the medically required/TriCare approved procedure. The ACS/MFS/FCI see rare diagnoses and has had three instances this year alone where accurate diagnosis of a rare medical condition would have been greatly helped by having an imaging capability of the endothelial cells. The diseases that require such imaging include: Fuchs' Endothelial Corneal Dystrophy, Posterior

Polymorphous Corneal Dystrophy, Iridocorneal Endothelial Syndrome at its subsets (Iris Nevus

Syndrome, Chandler's Syndrome, and Essential Iris Atrophy), Pseudophakic and Aphakic

Bullous Keratopathy, Congenital Glaucoma, and forceps delivery birth trauma.

Tasks/Scientific Goals: As the aviation program managers of the procedure to correct and treat this disease, our goal is to provide a quality pre and post op screening and plan of treatment for aviators. All findings will be logged into the candidate’s medical record.

Minimum requirements: This will be a one-time purchase order where the vendor will provide an All-in-one Specular Microscope which meets the below requirements:

1. All-in-one specular microscope that provides the surgeon with an endothelial cell count when performing corneal cross linking with the AVEDRO system, the only FDA approved device to treat keratoconus.

2. Non Contact- no physical touching of the eye to any part of the machine.

3. Range of 0.25 mm X 0.54 mm

Optical Microscope

Endothelial Layer Imaging

4. Automatic analysis- from a photographic scan the machine will count the endothelial cell density.

5. Captures at least 6 different peripheral points

6. Corneal thickness measurement accuracy +/- 10 microns

7. Measure number of cell/density/standard deviation/max cell area/coefficient of variation

8. LAN and printer outputs

9. DICOM Compatible to be linked to our enclave device for digital transfer of raw data for management group tracking and uploading into the electronic medical record

Delivery Schedule:

One-time delivery of all items no later than 60 calendar days after contract award.