Optometry critical of nontraditional eye exams

With the recent launch of alternative methods for patients to obtain prescriptions for contact lenses and glasses, optometrists are expressing doubt about the technologies and the message such practices send to patients about eye health.

Online refractive exam Opternative launched at the end of July, and Blink, an in-home vision test, was launched by EyeNetra in April. The American Optometric Association (AOA) has voiced “serious concerns” over such services separating refraction from a comprehensive eye exam.

A poll on Healio.com/Optometry showed that, at press time, 79% of respondents believed that online eye exams would prevent people from seeking a comprehensive exam from an eye care provider. Twenty-one percent of respondents said they believe online exams would provide more benefit than harm — motivating more people to seek a comprehensive eye exam, addressing the growing need for eye care services or making vision correction more easily accessible to more people.

Opternative

Opternative is a refractive eye exam that can be taken at home with the use of a smartphone and computer. Aaron Dallek, chief executive officer of Opternative, told Primary Care Optometry News that the exam utilizes “the same subjective principles as a traditional refraction done on a phoropter.”

After the online exam, an ophthalmologist licensed in the patient’s state reviews the patient results and medical history and writes a prescription, Dallek said.

He explained that the company, which had previously planned to make its technology available to the public in the spring or summer of 2015, first concentrated on a clinical trial.

“We’ve been focusing on perfecting our technology as we concluded a clinical trial that showed that the Opternative refractive vision exam is statistically equivalent to an in-office refractive exam,” Dallek said.

Currently, a prescription for glasses or contact lenses costs $40, or $60 for both, according to Opternative’s website. At launch, the service was made available to consumers in 27 states, and Dallek said that the company has plans for expansion.

As detailed on the company’s website, anyone may take the refractive eye exam, but to obtain a prescription, users must meet specific health, vision and age requirements. Consumers must be 18 to 40 years old and be within a prescription range that is emmetropic, non-presbyopic, myopic with spherical power between -0.25 D and -5.50 D, hyperopic with spherical power between +0.25 D and +2.50 D or astigmatic with cylinder power between -0.25 D and -2.50 D. Additionally, consumers cannot have recently reported flashes or floaters, acute eye pain or discomfort or have a history of neurological issues, brain injuries, amblyopia, hypertension, diabetes, glaucoma, retinal detachment or cataracts.

While consumers have been enthusiastic about the technology, according to Dallek, a majority of optometrists have voiced both concerns and outrage. Opternative has addressed this issue in three ways, Dallek explained.

“Opternative ensures patients understand our test covers the refraction portion of an eye exam,” he said. “Opternative recommends asymptomatic patients receive an eye health exam at least once every 2 years, the lower limit of what is recommended by the American Academy of Ophthalmology (AAO). We will not allow patients to take the online exam more than four times within 5 years if they have not received an eye health exam.”

Dallek said that patients with certain symptoms will either be prevented from using Opternative or will be encouraged to get an eye health exam more frequently.

He continued: “Opternative also provides each patient with a map and contact information for local eye care professionals to schedule an eye health exam.”

Ophthalmologists have been receptive to Opternative, Dallek said. Currently, the company is working only with ophthalmologists to approve prescriptions.

Bruce Goldstick, MD, an ophthalmologist who works with Opternative, said that the data he reviews is the same data that an eye care professional would have in an in-office consult.

“The process of writing a prescription involves logging into our HIPAA-compliant doctor’s portal,” he told PCON. “The prescription shows all of the necessary data required to evaluate a refractive prescription. In addition, a medical history is obtained before taking the test, and eligibility to take the test is predetermined.”

Goldstick shared that he feels the technology and process is intuitive, convenient and will increase accessibility.

“Our desire is to get people thinking about their eye health on a regular basis so Opternative becomes a tool to send people to their eye care professional,” he said.

Dallek told PCON that the company is also looking to expand its consumer base and work with optometrists.

“We are working on developing a bifocal test that will allow us to expand our services to some patients over 40 years old,” he said. “We would also like to share our technology with optometrists in hopes of helping improve patient efficiency so they can focus on eye health concerns.”

Optometry’s reaction to Opternative

Optometrists in Illinois, the state where Opternative began, are taking action against the technology. Michael G. Horstman, executive director the Illinois Optometric Association (IOA), told PCON: “The IOA is a strong supporter of technology and believes that our patients have and will benefit in the future from continued technological advances. We cannot, however, support technology that ignores the safeguards placed in current law to protect the health and safety of the patient. We have asked the Illinois Department of Financial and Professional Regulation to review Opternative’s system to determine whether it is in compliance with the Illinois Optometric Practice Act and the Illinois Medical Practice Act.”

Horstman stated that the IOA supports telemedicine technology that can be used in instances such as disease treatment and diagnosis or surgery comanagement, but does not believe that Opternative qualifies.

Image: Loomis S

“What Opternative is doing is not telemedicine in any form, because no ocular health assessment is performed,” he said.

Justin Bazan, OD, an optometrist who tried using Opternative, said that the company plays “into the public’s lack of knowledge about what a comprehensive eye exam is and market themselves as an eye exam,” he said. “If they were serious about eye care, they would require proof of an exam in accordance with the AOA guidelines before allowing one to do the refraction. My first exposure to Opternative’s misleading marketing was shocking. It was a video on the landing page of their website that basically said going to your eye doctor is a waste of time

“The fact that they are giving out contact lens prescriptions without even looking at the health of the cornea or the fit of the contact lens is mind blowing to me,” he continued. “That shows me they are not interested in what is best for the patient, just what is best for their pockets.”

Bazan took the test himself and found it to be frustrating, he told PCON.

“It felt like it took forever and it turned out that after I did it, my results weren’t good, and I was advised I had to do it again,” Bazan said. “So it took about an hour of my time, and I didn’t feel confident with the process or the results.”

Despite that, Bazan said, he believes that the technology has a potential within itself and within optometry.

“This is just the first generation; do you remember what the first generation of computers or cell phones was like?” he said. “I feel that we will see this technology continue to evolve, and it is my hope that optometry as a profession finds a way to positively incorporate it in a way that ensures our patients’ safety.”

Holly Salloga, OD, who practices in Pennsylvania, told PCON that she also took the Opternative online exam to be able to answer patients’ questions and said the experience was “terrible.”

“I figured there would be an ‘ah-ha’ moment when things came in clearly,” Salloga shared. “That never happened. I guessed for most of the test and was very unsure of myself.” She said that she opted not to pay for the actual prescription, but believes it would have been a copy of her current prescription.

“I was seeing 20/10 out of it, according to Opternative,” Salloga continued, “and I am actually only 20/20 out of it.”

Salloga said that, in her experience, Opternative seems to, in part, rely on old prescriptions, but she would not support it in any case. “Everyone should have a thorough eye exam that actually looks at the health of the eye,” she said. “Just today I saw a patient wanting to renew his contact lens prescription. He was a 21-year-old type 1 diabetic with corneas full of infiltrates unbeknownst to him. How can a computer diagnose that?”

Salloga continued: “If you decide to buy your glasses online and they are awful, you can always get a new pair. If you decide to buy your eye exam online, the consequences could be much worse and sight threatening.”

Opternative’s interface is intuitive and polished for consumers Harry M. Green, OD, PhD, FAAO, the director of UC Berkeley Digital Health, told PCON.

“However, I am unsure as to the accuracy of the results of its computer-based determination of refractive error,” he said. “When I am teaching students in the clinic, I tell them that a prescription is not what comes out of the phoropter, but a decision making process utilizing many pieces of information that they’ve obtained from the exam.

“Prescriptions need to be individualized based on more than just refractive error alone,” he continued. “I would assume their business model accounts for a certain percentage of re-dos, and they just accept that as it is.”

Green admitted that he has not gone through the Opternative process but is disappointed that it relies partly on a copy of a previous prescription. “If this truly is the case, this is not consistent with the standard of care associated with contact lens wear,” he said. “Standard of care for the purposes of renewing a contact lens prescription is for an eye care provider to examine the lens fit and dynamics on the eye. The eye care provider must also look for signs of ocular pathology caused by contact lens wear, which the patient may be completely unaware of.”

Blink

Blink is a refractive eye exam service in which a “visioneer,” who is not an eye care professional, comes to a patient’s home and collects refractive measurements, according to the company’s website. The service was developed by EyeNetra, which “was founded to develop and commercialize current and future MIT Media Lab research on methods to use smartphones to deliver personalized vision correction to the masses.”

EyeNetra provided no response to repeated inquiries by PCON.

Blink is currently available in parts of New York City, and the company has plans to expand in terms of location. According to the company’s website, the exam will provide consumers with a glasses prescription and costs $75 for one individual. If a consumer opts to take his or her exam with a friend, it costs $130, and with two friends it costs $170. Blink indicated that it donates toward a free test and glasses for someone in need for each paid exam.

The exam takes about 20 minutes, according to Blink, and uses handheld technology developed by EyeNetra, which has been registered as Class 1 Exempt with the FDA. This technology consists of the Netra, a refractor; the Netrometer, a lensometer; and the Netropter, a portable lens kit similar to a phoropter. Both the Netra and Netrometer use a smartphone.

As detailed in a webinar hosted byEyeNetra, the devices can all be used without dilation and cycloplegia. The Netra is about the size of a pair of binoculars, and patients locate a pair of red and green umbrellas and line up their stems while their eyes are measured from different angles. The Netrometer is pistol-like, according to the presenters, and reads single lenses in about 3 seconds. The company is currently working on a software update that will allow the Netrometer to read progressive lenses as well. The Netropter allows the tester to dial in sphere, cylinder and axis, can test both binocular and monocular vision and also measures pupillary distance, the presenters explained.

Optometrists review data collected by the visioneer along with patient data, which includes previous eye glasses history, according to a video on Blink’s website. Consumers receive their prescription within 24 hours. If the optometrist suspects an ocular health concern, or the patient has a visual acuity below a certain threshold, they will receive a referral instead.

According to its website, Blink hopes to make the public more aware of ocular health by making vision testing easier to access. To accomplish this, the company has taken several steps, which include verbally educating patients regarding comprehensive eye exams and the need to receive them every 2 years, asking patients to read about them before their exam and relying on a referral process. Additionally, each person who completes the exam receives a personal message, reminding adults and children to receive comprehensive exams every 2 years or annually, respectively.

“Finally, Blink strongly recommends customers who have used Blink once before to receive a comprehensive exam before they use Blink’s service again,” the company stated. “We reinforce this by adding a 25% surcharge every time a patient reuses Blink without having received a comprehensive eye exam in between.”

According to EyeNetra’s webinar, the devices will also be available for optometrists to purchase singularly and as bundles. Orders will be shipped in December, according to the company’s website.

Optometry’s reaction to Blink

The New York State Optometric Association (NYSOA) has filed a complaint against Blink, according to NYSOA president Michele Lagana, OD.

“The NYSOA filed a complaint with the Office of the Professions and the Office of Professional Discipline regarding Blink,” she told PCON. “We are concerned, regardless of whatever disclaimers Blink might make, that patients who receive mobile refractions from unsupervised and unlicensed ‘visioneers’ will assume that they have received a comprehensive eye health examination.”

Lagana said that the NYSOA is not opposed to cutting-edge technology, but is opposed to anything that undermines the doctor-patient relationship.

The complaint states that the “business model behind Blink is fundamentally inconsistent with New York State law and regulation and may pose a significant risk to the health of New Yorkers.”

Bazan, who practices optometry in New York, is also familiar with EyeNetra’s Blink. “Blink is sending out techs to help a patient do their own subjective refraction among other optometric testing such as a case history and lensometry,” he said. “Data is then reviewed by an eye doctor, much in the same way that Opternative does. However, Blink has a potential to add components and provide comprehensive eye care in a mobile setting.”

Green said that he is less experienced with Blink because it is not available online, but is still uncertain of its value.

“Because they actually take several measurements, I think their approach will provide better accuracy in prescribing glasses,” he said. “Their website also makes it clear that they do not provide comprehensive eye care and encourage people to seek it. However, it remains to be seen as to whether or not this increases compliance with comprehensive eye care because their service heightens awareness or if it decreases compliance with comprehensive eye care because most consumers are more interested in getting their glasses and contacts than receiving preventive eye care.”

Pushback from organized optometry

The AOA has issued several statements condemning online eye exams and stressing the importance of comprehensive eye exams.

“We have a serious concern about separating the refraction from a comprehensive eye examination,” Steven Loomis, OD, president of the AOA, told PCON.

“A refraction does not simply yield a spectacle or contact lens prescription,” he said. “A refraction in itself is a diagnostic test that yields information about potential health concerns like diabetes, cataracts and retinal issues, to name only a few.”

Loomis said that exams such as Opternative and Blink fail to meet those needs.

“The great concern we have is that the patient is likely quite unaware of the insufficiency of the product they have just purchased,” he explained. “That is why the AOA, along with its state affiliate associations, is actively combating misleading claims made by these so-called ‘online eye exams’ and mobile refracting services. Instead of improving access to care, these services actually are a barrier to care because the patient is misled into believing they’ve had a sufficient eye exam.”

That concern drove the AOA to take targeted actions, Loomis said. The AOA House of Delegates, at its June meeting, passed a resolution that stated: “Remote and patient-administered eye and vision care can involve unverified, inaccurate or misleading claims that may result in harm due to delayed care, missed diagnoses and/or disruption of the doctor-patient relationship.”

Loomis told PCON that he has contacted the FDA and requested an investigation of Opternative’s health claims, saying the system “relies on the unproven use of a medical device.”

“In addition, the AOA recently sent a letter to the president of the American Academy of Ophthalmology to also make a stand,” Loomis said. “I called on the AAO to rebuke the dangerously misleading product claims made by online eye exams and work alongside the AOA to safeguard public health and healthy vision.”

Loomis said that he believes there is a place for telemedicine within optometry, but that there is no substitute for in-person care.

“The AOA recognizes that technology can help doctors of optometry advance patient care,” he stated. “However, safeguards must be in place to ensure that patient health and safety are not compromised by claims that in-person care is unnecessary, and that care rendered via telehealth technology be held to the same standards as in-person visits.”

The Optometric Society also sent a letter to its members regarding both Opternative and Blink, calling them a “public health concern.” The organization reached out to optometry boards in states with Opternative to share their concerns and remind them of a law passed in Michigan that does not allow for that type of business model.

Ophthalmology supports new technology, with conditions

The AAO told PCON that it encourages technology such as Opternative, with specific conditions.

“The American Academy of Ophthalmology supports the use of new technology for improving efficiency and widening access to eye care,” Michael X. Repka, MD, MBA, medical director for governmental affairs at the AAO, said in an interview. “The academy is open to the use of online refractive exams for adults ages 18 to 40 with healthy vision so long as an ophthalmologist or optometrist is required to write the prescription. It is also crucial that the online provider clearly emphasizes that users should still have their eye health monitored through a comprehensive eye exam at least every 5 to 10 years.”

He continued: “Ideally, however, it may be best if online refractive exams are not used by people who have never had a comprehensive exam, but instead used by existing patients. For example, patients might use these technologies as a follow-up service in the year or years after they received a comprehensive eye exam.”

Repka’s statements are in line with the academy’s guidelines for comprehensive adult medical eye exams, which state that adults younger than 40 years with no risk factors should receive comprehensive medical eye evaluations every 5 to 10 years. According to the AAO, this includes “signs that are suggestive of a potentially abnormal condition or when risk factors for developing ocular disease are identified but the patient does not yet require intervention.”

The AAO’s guidelines differ from the AOA’s recommendations, however. The AOA states that patients 18 to 60 years old should receive a comprehensive eye examination every 2 years as long as they are asymptomatic or risk free. Risks are defined as patients “with diabetes, hypertension or a family history of ocular disease (e.g., glaucoma, macular degeneration), working in occupations that are highly demanding visually or eye hazardous, taking prescription or nonprescription drugs with ocular side effects, wearing contact lenses, who have had eye surgery or with other health concerns or conditions.”

A place in eye care?

Bazan and Green both believe that Opternative and Blink will prevent people from seeking a comprehensive eye exam.

“People don’t look forward to paying for eye care, and many consider going a hassle,” Bazan said. “If they can sidestep that expense and hassle, they will. They fail to realize how important annual comprehensive eye care is.”

“Public perception is that you visit an eye care provider for glasses or contacts, unless you have an eye disease you know about,” Green stated. “This perception is solidified by the patient’s own experience. They think that if they feel their vision is good, then nothing must be wrong. However, there are many ocular conditions that can cause vision loss that the patient is not symptomatic for until much of the damage is done.

“This approach may also delay comprehensive care because a patient thinks their sudden change in vision can be solved using one of these methods,” Green continued. “By the time they get their glasses, there may be permanent damage.”

The practitioners agree that the technologies might help address the growing need for eye care services but are skeptical they will help in the right ways.

“To a point, maybe, but much of the growing need for eye care is not for glasses and contact lenses, it is for increased incidence and prevalence of ocular disease,” Green said. “These approaches are based on the consumerism associated with the purchase of glasses and contacts, for which there is a huge market.”

“The issue is that if someone is given their desired prescription, despite being told they should have an exam at least every 2 years, they probably won’t act on it,” Bazan said. “They have what they need, and until they have a ‘real’ eye problem most will not seek care.”

Green told PCON that optometrists should focus on eye health to keep patients in their offices.

“The best thing optometrists can do is to minimize the importance of the glasses/contact lens portion of the exam and focus much more on the ocular health evaluation as the true purpose of the exam,” he said. “This should be emphasized to the patient throughout the exam.”

There is a place for telemedicine in optometry, Green said, but entities such as Blink and Opternative do not qualify, as they do not supply medical care or services. “True telemedicine can be an outstanding tool for the identification and triage of eye disease and is already a burgeoning field,” he said. “However, I don’t believe that the technology we have today can even come close to replacing comprehensive eye care. Who knows what the future may hold, though?” – by Chelsea Frajerman Pardes

• For more information:
• Justin Bazan, OD, can be reached at dr.bazan@parkslopeeye.com.
• Aaron Dallek can be reached at aaron@opternative.com.
• Bruce Goldstick, MD, can be reached at BGoldstick@aol.com.
• Harry M. Green, OD, PhD, FAAO, can be reached at harryg@berkeley.edu.
• Michael G. Horstman can be reached at ioaed@ioaweb.org.
• Michele Lagana, OD, can be reached at rocheyedoc@gmail.com.
• Steven Loomis, OD, can be reached at SALoomis@aoa.org.
• The Optometric Society can be reached at www.theoptometricsociety.org.
• Michael X. Repka, MD, MBA, can be reached at SDang@aao.org.
• Holly Salloga, OD, can be reached at eyenerd@verizon.net.

Disclosures: Bazan, Green, Horstman, Lagana, Loomis, Repka and Salloga report no relevant financial disclosures. Dallek is employed by Opternative. Goldstick is president of Optimized Eye Care, a company that utilizes Opternative’s technology, and also serves as an advisor to Opternative.