A weekly e-journal by Art Epstein, OD, FAAO


Volume 18, Number 41

Monday, October 9, 2017


Inside this issue: (click heading to view article)
######### Off the Cuff: Is Hubble in Trouble?
######### Changes in Thickness of Central Macula and Retinal Nerve Fiber Layer in Severe Hypertensive Retinopathy: a One-year Longitudinal Study
######### Evidence for Cerebrospinal Fluid Entry Into the Optic Nerve Via a Glymphatic Pathway
######### Tolerable Rates of Visual Field Progression in a Population-based Sample of Patients with Glaucoma
######### News & Notes

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Off the Cuff: Is Hubble in Trouble?

Founded by fast-track millennials Ben Cogan and Jesse Horwitz, Hubble Contacts was inspired by disruptive consumer specialty marketers Dollar Shave Club and Harry’s. Hubble sells what are essentially generic daily-disposable lenses for about $30 a month. And while cheap contact lenses are an attractive proposition for many patients, you might be wondering what brand Hubble sells so cheaply. Nothing you are likely to be familiar with. St. Shine Optical in Taiwan makes Hubble contact lenses. I know, you’ve never heard of St. Shine.

You probably already figured out the potentially huge problem that Cogan, Horwitz and their equity fund backers missed. Contact lenses are medical devices regulated by the U.S. government. You can’t just mail out contact lenses willy-nilly like you would cheap razors. Unless Hubble can influence changes in Federal law permitting generic substation or find enough ODs and MDs interested in fitting their lenses—both of which are extremely unlikely, substituting Hubble lenses for a another brand without proper professional supervision would be both illegal and risky. Eventually, a Hubble wearer will end up with a nasty sight-threatening corneal ulcer. While I wouldn’t want to be that patient, I would like to be their attorney.

We’ve recently started receiving phone calls from an 844 number requesting verification of contact lenses that we’ve never fitted for patients whose names we either can’t make out or who have not been seen in our practice. In one case, the call just played several minutes of elevator music. While the company doesn't identify itself, our calls to its contact, Paul Rodgers, have gone unanswered.

I suspect these prescriptions are being filled under passive verification rules. As a result, our staff is instructed to immediately fax back a formal rejection of these inappropriate Rx verification requests. You should be doing the same. If you can’t recognize a patient’s name or other identifying information, you are obligated to decline verification, or accept medical and legal responsibility for a prescription you had nothing to do with.

So what is the long-term prognosis for Hubble? As I see it, the company has a very limited financial window. To get low pricing, Hubble had to make a deal with St. Shine, which committed to purchase (and sell) huge numbers of contact lenses—the cofounders say as much in this Forbes interview. And the private equity folks who lent them millions will soon be growing impatient, looking for a return on their investment that may never materialize. All of these challenges considered, Hubble might well be in trouble.

Arthur B. Epstein, OD, FAAO
Chief Medical Editor


Want to share your perspective? Write to Dr. Epstein at artepstein@optometricphysician.com.

The views expressed in this editorial are solely those of the author and do not necessarily represent the opinions of the editorial board, Jobson Medical Information LLC (JMI), or any other entities or individuals.



Changes in Thickness of Central Macula and Retinal Nerve Fiber Layer in Severe Hypertensive Retinopathy: a One-year Longitudinal Study
This study analyzed the longitudinal changes in the thickness of the central macula and retinal nerve fiber layer (RNFL) in patients with hypertensive retinopathy (HTNR) using spectral-domain optical coherence tomography (SD-OCT). This was a prospective cohort study. Researchers studied 18 eyes of patients with HTNR of grade IV who had been followed for more than one year, and 36 normal eyes (without any relevant medical history; the control group). Antihypertensive treatment successfully normalized the blood pressure of HTNR patients. The RNFL thickness and that of the central macula of HTNR patients were measured using a Cirrus HD-OCT instrument, and compared with those of the control group.

At 12 months of follow-up, the mean thickness of the RNFL and central macula was significantly lower in the HTNR group than in the control group (the RNFL was measured first, and then the central macular thickness (CMT): 77.4 ± 9.1 μm and 233.8 ± 30.8 μm vs. 94.1 ± 7.8 μm and 256.3 ± 28.1 μm, respectively). With time, the RNFL thickness and CMT became significantly less than that at the initial diagnosis.

Researchers concluded that severe HTNR caused a decrease in the thickness of the RNFL and central macula over time. Therefore, they added, the impact of retinal changes associated with systemic diseases such as hypertension should be considered in analyzing the thicknesses of the RNFL and central macula in ocular disorders, including retina, glaucoma and neuro-ophthalmologic diseases.

Lee HM, Lee WH, Kim KN, et al. Changes in thickness of central macula and retinal nerve fibre layer in severe hypertensive retinopathy: a 1-year longitudinal study. Acta Ophthalmol. 2017; Oct 4. [Epub ahead of print].

Review of Optometry's New Technologies and Treatments in Eye Care in Philadelphia, November 3-5, 2017 at Loews Hotel Philadelphia

Evidence for Cerebrospinal Fluid Entry Into the Optic Nerve Via a Glymphatic Pathway
The purpose of this study was to determine whether cerebrospinal fluid (CSF) entered the optic nerve via a glymphatic pathway and whether this entry was size-dependent. Fluorescent dextran tracers (fluorescein isothiocyanate [FITC]) of four different sizes (10, 40, 70 and 500 kDa) and FITC-ovalbumin (45 kDa) were injected into the CSF of 15 adult mice. Tracer distribution in the orbital optic nerve at one hour after injection was assessed in tissue sections with confocal microscopy. Tracer distribution within the optic nerve was studied in relation to blood vessels and astrocytes identified by isolectin histochemistry and glial fibrillary acidic protein (GFAP) immunofluorescence, respectively. Aquaporin 4 (AQP4) immunostaining was performed to assess astrocytic endfeet in relation to CSF tracer.

One hour following the tracer injection into the CSF, all tracer sizes (10 kDa to 500 kDa) were noted in the subarachnoid space surrounding the orbital optic nerve. In all cases, 10 kDa (n=4/4) and 40 kDa (n=3/3) tracers were noted within the optic nerve, while 70 kDa tracer was occasionally noted (n=1/4). Tracer found within the nerve was specifically localized between isolectin-labeled blood vessels and GFAP-positive astrocytes or AQP4-labeled astrocytic endfeet. The 500 kDa tracer was not detected within the optic nerve.

Investigators wrote that, to their knowledge, this was the first evidence of a glymphatic pathway in the optic nerve. CSF entered the optic nerve via spaces surrounding blood vessels, bordered by astrocytic endfeet. In addition, they determined that CSF entry into paravascular spaces of the optic nerve was size-dependent and that this pathway might be highly relevant to optic nerve diseases, including glaucoma.

SOURCE: Mathieu E, Gupta N, Ahari A, et al. Evidence for cerebrospinal fluid entry into the optic nerve via a glymphatic pathway. Invest Ophthalmol Vis Sci. 2017;58(11):4784-91.



Tolerable Rates of Visual Field Progression in a Population-based Sample of Patients with Glaucoma
Participants with open-angle glaucoma (OAG) in the Thessaloniki Eye Study (cross-sectional, population-based study in a European population) were included in this analysis to provide population-based data on the maximum tolerable rate of progression to avoid visual impairment (maxTRoP_VI) and blindness (maxTRoP_BL) from OAG. Visual impairment was defined as mean deviation (MD) equal to or worse than -12 dB and blindness as MD equal to or worse than -24 dB. Additional thresholds for visual impairment were tested. For each participant, maxTRoP_VI was defined as the rate of progression that would not lead to visual impairment during expected lifetime. MaxTRoP_BL was defined accordingly. Both parameters were calculated for each OAG subject using age, sex, MD and life expectancy data. The eye with the better MD per subject was included in the analysis.

Among 135 subjects with OAG, 123 had reliable visual fields and were included in the analysis. The mean age was 73 years ± 6 years, and the median MD was -3.65 dB ± 5.28 dB. Among the participants, 69.1% were found to have a maxTRoP_VI slower than -1 dB/year and 18.7% were found to have a maxTRoP_VI between -1 dB and -2 dB/year. Also, 72.4% were found to have a maxTRoP_BL slower than -2 dB/year. For all tested thresholds for visual impairment, approximately 86% of the OAG participants would not be able to tolerate a rate of progression equal to or faster than -2 dB/year.

The majority of patients with glaucoma in this study were found to have a maximum tolerable rate of progression slower than -1 dB/year in their better eye. Researchers concluded that patient-tailored strategies to monitor the visual field were important, but raised the issue of feasibility with regard to the number of visual field tests needed.

SOURCE: Salonikiou A, Founti P, Kilintzis V, et al. Tolerable rates of visual field progression in a population-based sample of patients with glaucoma. Br J Ophthalmol. 2017; Sep 28. [Epub ahead of print].

News & Notes
Ennco Offers Multi-option Product Configuration
Ennco Display Systems debuted a “product configurator” with a fully functional pricing module to its current ecommerce website. The company has been working to find a way to enable clients to select a basic item and then add color, frame display options, storage options, lighting options and more. Dispensing tables and complete panel systems are the first products to roll out with the new formats. Clients can shop options and price out dispensing tables and wall panel systems as they are made available. Read more.


SciFluor Releases Positive Phase I/II SF0166 Study Results
SciFluor Life Sciences released positive top-line results of its Phase I/II study of SF0166, the company’s lead drug in development for the topical treatment of diabetic macular edema. The primary outcome measure of safety was achieved with no drug-related serious adverse events throughout the 28-day course of treatment as well as during the follow-up period. The study assessed the safety and preliminary efficacy of SF0166 in 40 evaluable patients with DME who were randomized to one of two dose strengths (2.5% and 5% solutions) self-administered by patients as an eye drop twice a day for 28 days. Read more.

IOPtima Launches Lipitear Phospholipid Microemulsion
IOPtima announced the launch of Lipitear, a microemulsion formed by aqueous and lipidic phases that help to restore the proper microenvironment of the ocular surface, enhance the physiological process of corneal re-epithelization following ocular surgery, and reduce the typical symptoms and signs of ocular surface disorders. Read more.

Alcon AcrySof IOL Reaches 100 Million Implants
Alcon’s AcrySof intraocular lens platform for the treatment of cataracts has been implanted more than 100 million times. To mark the accomplishment, Alcon launched the 100 Million Moments Made campaign in global markets. The first recorded implantation of an AcrySof IOL was in the UK in 1990. Read more.

AAOF Awards Korb - Exford Dry Eye Career Development Grant
The American Academy of Optometry Foundation selected the inaugural recipient of the Korb - Exford Dry Eye Career Development Grant. Srihari Narayanan, OD, PhD, FAAO, professor at the University of the Incarnate Word Rosenberg School of Optometry, who is leading the study “Meibomian Gland Dysfunction management to relieve contact lens discomfort,” was chosen to receive the grant. Dr. Narayanan will be honored at the AAOF Celebration Luncheon during AAO’s annual meeting in Chicago. Read more.

Allergan Research Grant Recipient Named
AAOF, in partnership with the Allergan Foundation, has given the Allergan Research Grant to Rose Y. Reins, PhD, assistant professor at The Ocular Surface Institute, University of Houston College of Optometry. The $60,000 grant will support Dr. Reins’ project titled “Evaluation of Vitamin D Treatment for Dry Eye-induced Ocular Surface Inflammation.” The award is given to an optometrist or vision scientist and Academy member who is undertaking cutting-edge research in the areas of glaucoma or the anterior segment. Read more.

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Review of Optometry's New Technologies and Treatments in Eye Care in Philadelphia, November 3-5, 2017 at Loews Hotel Philadelphia




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Optometric Physician™ Editorial Board

Chief Medical Editor
Arthur B. Epstein, OD, FAAO

Journal Reviews
Shannon Steinhäuser, OD, FAAO

Contributing Editors
• Katherine M. Mastrota, MS, OD, FAAO
• Barry A. Weissman, OD, PhD, FAAO (Dip CL)

Editorial Board
• William Jones, OD, FAAO
• Alan G. Kabat, OD, FAAO
• Bruce Onofrey, RPh, OD, FAAO
• John Schachet, OD, FIOS
• Joseph Shovlin, OD, FAAO



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