valley contax
CUSTOM STABLE | SPOTLIGHT
CASE STUDIES, TIPS & RESOURCES - JULY 20‌17 EDITION
FDA CLEARANCE CASE REPORT
A Closer Look At How The Custom Stable Received 510(k) Clearance
James Deom O.D., M.P.H., F.A.A.O.
Medical Director of The Scleral Lens Institute The Dry Eye Center of Northeastern Pennsylvania Hazleton and Stroudsburg Eye Specialists
Valley Contax recently received 510(k) clearance by the U.S. Food and Drug Administration (FDA) for our Custom Stable line of scleral contact lenses indicated for the therapeutic management of several ocular conditions and also achieved clearance for the management of dry eye syndrome. In this issue we’re sharing one of the case reports we used to achieve this goal.
Patient 65 Year Old Female Initials: CD
Indication: Dry Eye Disease
Medical History: Hypertension, Hypercholesterolemia , Diabetes, Rheumatoid Arthritis
Ocular History: Artificial tear use every hour ou while awake. Cyclosporine .05% BID OU. Unable to read for more than 5 minutes due to eye burning from severe dry eye. Uses Omega 3 supplements, eye lid washes BID ou with baby shampoo, and warm compresses BID ou for 10 minutes each application.
Spectacle Rx
OD -1.50 sph
OD -3.50 sph
add
+2.50
+2.50
D
20/30
20/30
N
20/30
20/30
Figure 1 : Grade 3 keratitis from severe dry eye disease OD.
Figure 2: Grade 3 keratitis from severe dry eye disease.
Uncorrected VA (distance and near):
Distance: OD: 20/60, OS: 20/60
Near: OD: 20/30, OS: 20/30
Slit lamp photos with device
Figure 1, 2, 3: Custom Stable Aurora displaying acceptable vault OD, edge alignment temporal OD, edge alignment temporal OS.
Figure 4, 5: Resolution of keratitis post Custom Stable wear OD , Resolution of keratitis post Custom Stable wear OS.
Device Parameters: Custom Stable Aurora
OUTCOME
Visual Acuity with Custom Stable Aurora
Distance: OD: 20/20, OS: 20/20
Near: OD: 20/20, OS: 20/20
Clincial Evaluation: Wear time – 12 hours of continuous wear with no discomfort. Excellent vision and comfort distance and near through the entire wear period. CD was for the first time in many years able to read the newspaper and novels for hours at a time. She also dramatically reduced her artificial tear use to QID OU. She continues to take cyclosporine .05% drops bid ou. She notes stable and comfortable vision far superior to her spectacles she wore prior. CD was never a contact lens wearer prior to her Custom Stable lenses.
Custom Stable Fridays: Hands-on Education
Want to hit the fast track to learning how to fit the Custom Stable™? Join us for one of our Custom Stable Friday sessions. This is a hands-on approach to learning everything you need to know about fitting, application and removal at our state of the art facilities in Springfield, Oregon. Check our website or contact us for available dates and more info.
The Custom Stable™ is a life changing scleral lens that can transform your practice. It fits easy, has exceptional visual acuity and provides all day comfort. With its ability to vault the cornea and create a natural tear lens the Custom Stable™ is a great fit for regular and irregular corneas that need the best in comfort and performance. Contact Valley Contax today to get started.
valleycontax.com | 800-547-8815 | contax@valleycontax.com
For superior performance and comfort Valley Contax recommends Optimum GP materials by Contamac for the Custom Stable line of lenses.
FIRST FREE RISK FREE
FITTING SET OFFER
60 DAY MONEY BACK GUARANTEE + FIRST FIT FREE
Order our 12 lens Custom Stable Elite fitting set at the discounted price of $300 and we’ll give you your first pair free! Plus if you’re not completely satisfied, return the fitting set within 60 days for a full refund! Call, email or chat live via our website to take advantage of this amazing offer!
800-547-8815 | contax@valleycontax.com | valleycontax.com
AMIGOS EYE CARE
We are proud to promote Amigos Eyecare, a student led organization at Pacific University College of Optometry which provides medical eyecare to underprivileged areas around the world. Averaging seven trips worldwide per year, one of the slated trips will be to Tanzania, east-Africa in December 20‌16.

With the assistance of the The Oregon Sight and Hearing Foundation(a project of the Lions Club) and many other groups which help to collect ‘old glasses’, students and doctors are able to examine & dispense glasses to those who would otherwise not have access to medical eye care and vision services.
This is an area of the world with great need, many of the nomadic people (the Maasai) have never seen a doctor of any sort in their lives. The amount of pathology & blindness in Tanzania is staggering. Ultraviolet light exposure is the leading cause of cataract formation, it can also contribute to macular degeneration and pterygium formation. These three causes of blindness could be reduced significantly by wearing non-prescription sunglasses.
amigos@pacificu.edu | amigoseyecare.org
custom stable | Tranning Course
You Tube
Want to learn to fit the Custom Stable lens? It’s easy, just visit our website and take the Custom Stable Training Course. It’s free, just watch the 17 minute video and complete the quiz. You’ll receive a certificate of completion and a coupon once you’ve passed.
This is a publication of Valley Contax, the world’s leading independent custom contact lens manufacturer. If you enjoy these case studies be sure to subscribe so you never miss an issue.
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About Valley Contax
Valley Contax is the world’s leading independent custom contact lens manufacturer. Since 1981 we’ve built a reputation and following for exceptional products and customer service. From our state-of-the-art facilities in Springfield, Oregon we staff the industry’s most talented lab technicians, customer care specialists and lens consultants. Contact us today, we’d love to get to know you.
valley contax
valleycontax.com | 800-547-8815 | contax@valleycontax.com