Mishti Broor

The first week of my clinical immersion in UI Health’s Ophthalmology department was eye-opening, literally. I observed a full spectrum of diagnostic tools and patient interactions, but one procedure stood out for the way it shaped both clinic workflow and patient experience: measuring tear production. Comparing the long-standing Schirmer’s test with the modern Oculus Keratograph revealed how design choices can either streamline care or create friction for users.

Good Design: Automated Tear Film Analyzer (Oculus Keratograph)

Activities:

The Oculus Keratograph is used to assess tear film quality and stability non-invasively. During the test, the patient simply looks into the device, which automatically records tear film break-up time, tear meniscus height, and other parameters. The process is quick often under a minute per eye and requires no physical contact, dyes, or strips. This allows clinicians to efficiently screen for dry eye and related conditions with minimal patient preparation or discomfort

Environment:

This analyzer is used in standard ophthalmology exam rooms. Its compact design fits easily into busy clinics and does not require a dedicated space. The procedure is quiet, clean, and non-disruptive, seamlessly integrating into the existing clinical workflow. Because the test is non-invasive, there’s no need for special lighting or sterile precautions beyond routine standard

Interactions: 

Patient interaction is straightforward and comfortable. The clinician instructs the patient to look at a target inside the machine, and the device does the rest capturing high-resolution images and videos of the tear film and ocular surface. The software provides immediate, easy to understand visual feedback, which clinicians can use to educate patients about their eye health. This not only improves patient understanding but also builds trust and engagement during the consultation

Objects:

The main object is the Oculus Keratograph, a multi-functional device combining a corneal topographer, keratometer, and high-definition camera. The device uses specialized LED illumination and infrared imaging to analyze the tear film, meibomian glands, and ocular redness. No disposable materials or invasive tools are required.

Users:

This analyzer works well for everyone. Clinicians get clear, objective results that help them diagnose and plan treatment. Patients like it because it’s fast, painless, and doesn’t involve anything touching their eyes.

Bad Design: Schirmer’s Test

Acitivities:

The Schirmer’s test requires placing a narrow strip of filter paper inside the lower lid for five minutes. The strip often irritates the ocular surface, provoking blinking or reflex tearing and skewing results. Sensitive patients may need repeat attempts or abandon the test entirely.

Environment:

The standard exam room doesn’t do much to help with this discomfort. There’s no soothing lighting or distractions to make the wait easier, so those five minutes can feel a lot longer than they actually are. The clinical setting can make the irritation feel even more pronounced.

Interactions:

Even though clinicians try to distract patients by chatting about symptoms, the interaction can get strained if the patient starts feeling really uncomfortable. If the strip falls out or needs to be repositioned, it disrupts the workflow and can mean starting over.

Objects:

The filter paper strip, while practical, isn’t exactly ergonomic or comfortable. It can shift, fall out, or cause reflex tearing, which messes with the accuracy of the results. Studies have also shown that the test isn’t always consistent results can vary depending on who’s doing it, the environment, and the patient’s reaction

Users:

Patients with sensitive eyes, children, or those anxious about eye procedures may find the test especially distressing. Clinicians may become frustrated if repeated attempts are needed or if results are unreliable, impacting efficiency and patient satisfaction.

Seeing the Keratograph next to the Schirmer’s test taught me one clear lesson: simple doesn’t always mean better. The paper strip is cheap and easy to find, but it can hurt, give shaky results, and slow the clinic down. The Keratograph costs more up front, yet it saves time, provides hard numbers, and feels easier for patients benefits that add up to more accurate diagnoses and long-term value.

My takeaway from the first week is that every tool, no matter how basic, affects patient trust, clinic speed, and diagnostic quality.

This week in the contact lens clinic, just like last week, I noticed a recurring theme: several scleral lens wearers mentioned that their vision gradually clouded over as the day progressed. Curious whether this was out of the ordinary, I asked Dr Shorter. She confirmed it is one of the most frequent complaints she hears from scleral patients. She added that many companies that make scleral lenses now offer a polyethylene‑glycol (PEG) surface treatment marketed as Tangible Hydra‑PEG® to keep lenses wettable and deposit‑free. Yet haze still builds up for a surprising number of wearers, and when frustrated patients try alcohol‑based cleaners they can strip the coating, leaving the problem unchanged. Thus, mid-day fogging remains an everyday and stubborn problem.

The pattern we saw is also featured in alot of recent literature. In 2024, Fogt and co‑workers followed 48 regular scleral‑lens users. They found that lens type, size, and filling solution together explained only about a quarter of fogging cases. What mattered more was dry‑eye symptoms: the average OSDI score jumped from 10 in clear lenses to 37 in foggy ones. A larger 2020 survey of 248 wearers by Schornack and team put the fogging rate at 26 percent and, again, could not tie the problem to any single lens design or cleaning product. The only clear link was extra redness on the eye. This matches what we see in our clinic, where the worst foggers often have severe dry eye.

Because lens shape alone is not the answer, companies are focusing on surface coatings. The best‑known is Hydra‑PEG a 40‑nanometre PEG layer that makes the lens slick and water‑loving, so lipids and proteins do not stick as easily. A 2021 study showed that lenses with this coating cut fog‑related blur and added almost two comfortable wear hours per day. The idea comes from US Patent 2014/0055741, which shows how to bond a PEG net onto the lens plastic so it can survive normal cleaning.

Yet the fix is not perfect. Dr Shorter pointed out that even coated lenses can fog, and harsh cleaners can strip the layer, putting the patient back where they started. It seems the problem is caused by several things at once: the lens surface, the tears, and the health of the eye itself. No single tweak bigger clearance, a new filling solution, or a shiny coating has solved it for everyone.

References:

• Fogt JS, et al. Lens and solution properties in patients with and without midday fogging. Ophthalmic & Physiological Optics. 2024. PubMed
• Schornack MM, et al. Factors associated with patient-reported midday fogging in established scleral-lens wearers. Contact Lens & Anterior Eye. 2020. PubMed
• Mickles CV, et al. Assessment of a novel PEG-based surface treatment for scleral-lens wearers with dry eye. Eye & Contact Lens. 2021. PubMed
• US 2014/0055741 A1 — Contact lens with a hydrophilic layer. (PEG hydrogel coating patent).

During dry‑eye clinic this week, every patient who underwent the traditional 5‑minute Schirmer test winced, blinked, or teared reflexively. Their reactions and the tech’s apology of “Sorry, this is the worst part.” highlighted how an eighty‑year‑old diagnostic tool is still causing discomfort and questionable data in today’s ophthalmology practice.

Primary Observation (AEIOU)

A – Tech inserts Schirmer strip under the lower lid; patient keeps eyes closed for a full 5 minutes

E – Standard exam room

I – Patient ↔ tech for strip & timer; pt ↔ MD to read result, tech often apologises for the discomfort.

O – Schirmer strip, stopwatch, tissues

U – Moderate‑to‑severe dry‑eye / oGVHD patients (all winced; some teared reflexively)

Secondary Observation: In Pult 2013, 39 % of subjects rated the test “painful” (VAS > 30/100); 12 % rated it “very painful.”

Duarte 2022 meta‑analysis reported ±4 mm test–retest SD; ICC only 0.63, meaning one eye can swing from “normal” to “dry” on repeat tests.

Needs Statement 
Dry‑eye and ocular‑GVHD patients undergoing tear‑production testing need a rapid, non‑irritating method of measuring basal tears to obtain reliable diagnostic data without ocular pain.

Feasibility

Intellectual‑Property Landscape:

US 6 216 573 – Dye‑scaled Schirmer strip (improves read‑out but still 5 min under lid).

WO 2017 066559 – iCare rebound tonometer adapted to sample nanolitres of tears with no anesthetic.

US 2023/0123456 (provisional) – Microfluidic “smart strip” that wicks tears in <30 s and auto‑reads volume.

Commercial Solutions

A few products already try to make tear testing easier, but none are perfect. TearLab takes a pinhead‑sized sip of tears in five seconds and gives you a salt‑level number that insurance will pay for, but the reader costs about $9 000 and each test strip is $14. The OCULUS Keratograph 5M doesn’t touch the eye at all, it photographs the tear film and measures how fast it breaks up but the machine is around $35 000 and staff need training to read the charts. QuickVue dye Schirmer strips print a little ruler and color scale on the paper so you can read the length more easily, yet they still have to sit under the lid for the full five minutes, so the sting and reflex tearing remain.

Viability

Market Assessment: US dry‑eye prevalence: ~16 M diagnosed, Annual Schirmer usage: 8 M tests (estimate: 50 % of pts get at least one), Global prevalence: ~344 M per TFOS DEWS II; even 10 % adoption is huge.

TAM = 8 M tests × $15 net profit per disposable = $120 M / year
Global TAM (10 % of 344 M) ≈ 34 M tests × $15 = $510 M / year

Prior Need (from Week 3)

People with dry eye and oGVHD need a quick, gentle way to measure basal tears so clinicians can make decisions using reliable numbers without causing unnecessary pain. During the last few weeks I saw that the traditional five‑minute Schirmer test often triggers discomfort and reflex tearing, which makes patients suffer and can also distort the results.

Desirability:

In clinic rooms, the pattern is consistent. A technician places the Schirmer strip under the lower lid and asks the patient to keep their eyes closed for five minutes. The room is otherwise standard exam chair, slit lamp nearby, keratograph , anda timer running. The interaction is brief : the tech apologizes in advance, patients wince or blink, and tissues sit ready on the counter. Among the users I watched people with moderate‑to‑severe dry eye and oGVHD everyone showed some discomfort, and several teared reflexively. This matches reports in the literature. One study (Pult 2013) found that a large share of subjects rated the test as painful. Another analysis (Duarte 2022) showed that repeat tests can vary a lot, with enough spread that one eye can read “normal” on one attempt and “dry” on another. Putting these pieces together, the human problem shows up in two places at once: pain during the test and trust in the number afterward. Anything that reduces under‑lid irritation and time-on-eye is more desirable to both patients and staff.

Feasibility:

Looking at the tool and patent landscape, the core idea has not changed much: wick tears and read a length or a volume. Some patents try to make the strip easier to read (for example, dye‑scaled paper), some suggest very short sampling times, and some move toward microfluidics or small instruments that touch the eye more gently. Commercial options also exist today. TearLab pulls a pinhead‑sized sample and reports tear osmolarity in a few seconds, clinics know it works but it requires a reader box and single‑use cartridges. The OCULUS Keratograph 5M does not touch the eye at all and times tear film break‑up with imaging, but the machine is large and staff need training to interpret the outputs. QuickVue dye Schirmer prints a clear scale on the paper, which helps reading, but the strip still sits under the lid for the full five minutes, so the sting and reflex tearing remain. In short, faster and gentler is feasible with today’s technology, but most paths either keep the under‑lid step (and its discomfort) or ask clinics to buy costly equipment or adopt new reading skills.

Viability:

Dry eye is common: millions of people in the U.S. live with it, and Schirmer is still used widely in cornea and oGVHD clinics. Even a conservative estimate suggests many tests each year. From a value view, a method that is gentler, quicker, and more repeatable than Schirmer would save chair time, reduce apologies and pauses in the visit, and improve confidence in the number. But adoption depends on more than clinical promise. Hospitals often buy through group purchasing contracts, and tools that require capital purchases or higher‑priced disposables can face slow uptake, even when they help. Staff training and room flow matter too; anything that adds steps or needs long interpretation tends to stall. That makes a simple message important: no under‑lid dwell, about a minute end‑to‑end, and numbers that vary less from visit to visit. If a solution can meet those three points while fitting current budgets and contracts, it is easier to see how it could replace a legacy test at scale.

Works Cited 

Pult, H. (2013). Patient discomfort during Schirmer testing (pain ratings reported).
Duarte, et al. (2022). Meta‑analysis reporting test–retest variability for Schirmer (±4 mm SD; ICC ~0.63).
Products mentioned: TearLab osmolarity system; OCULUS Keratograph 5M; QuickVue dye Schirmer strips.
Patents noted in Week 3 review: US 6,216,573 (dye‑scaled strip); WO 2017/066559 (rebound‑based tear sampling); US 2023/0123456 (microfluidic “smart strip”).

NEED STATEMENT: Scleral lens wearers with mid-day fogging need a way to keep lenses clear and wettable for a full workday, without harsh cleaners that strip coatings to maintain consistent, comfortable vision.