Latest / Glaucoma, Vision & Longevity: Supplements & Science / Smart Contact Lenses for IOP Monitoring: August 2026 Clinical Utility Results
Transcript
- 0:00SPEAKER_00: Smart Contact Lenses for Intraocular Pressure Monitoring.
- 0:03SPEAKER_00: August 2026.
- 0:05SPEAKER_00: Clinical Utility Results.
- 0:07SPEAKER_00: Evidence reviewed through August 18, 2026.
- 0:12SPEAKER_00: Introduction.
- 0:13SPEAKER_00: Smart contact lenses and other wearable sensors aim to solve a major problem in glaucoma care.
- 0:19SPEAKER_00: Eye pressure is measured only occasionally in most clinics, even though it changes throughout the day and may rise during sleep or while lying down.
- 0:26SPEAKER_00: The August 2026 evidence is promising but more limited than some headlines suggest.
- 0:32SPEAKER_00: The newest soft contact lens studies show that overnight and closed eye monitoring is technically feasible.
- 0:38SPEAKER_00: However, there is still no large peer-reviewed clinical trial showing that an external smart contact lens improves vision, slows glaucoma progression, or reliably changes treatment based on automated alerts.
- 0:52SPEAKER_00: The strongest real-world evidence for remote treatment decisions comes from implantable telemetric sensors and to a lesser degree home rebound tonometry rather than from external smart contact lenses.
- 1:03SPEAKER_00: Nocturnal Soft Contact Lens Study.
- 1:06SPEAKER_00: Ongoing smart contact lens trial.
- 1:08SPEAKER_00: Implantable sensor progression study.
- 1:10SPEAKER_00: Executive Summary.
- 1:12SPEAKER_00: New soft contact lens technology.
- 1:14SPEAKER_00: The 2026 Nocturnal Sensor demonstrated closed eye and recumbent monitoring in a very small human pilot involving a healthy participant and a participant with pigmentary glaucoma.
- 1:25SPEAKER_00: It reported encouraging comfort and signal stability, but no cohort-level adherence, data completeness, treatment change, or vision outcome results.
- 1:35SPEAKER_00: Advanced materials report Triggerfish.
- 1:37SPEAKER_00: The commercially available Sensimed Triggerfish detects changes in ocular dimensions related to pressure rather than directly reporting pressure in millimeters of mercury.
- 1:48SPEAKER_00: It can identify the likely timing of pressure peaks, but its United States authorization limits clinical use to helping identify when conventional pressure measurement should be performed.
- 2:00SPEAKER_00: United States Food and Drug Administration, United States Food and Drug Administration Review.
- 2:06SPEAKER_00: Implantable IMATE sensors.
- 2:08SPEAKER_00: These devices provide the most mature, continuous telemetric data.
- 2:12SPEAKER_00: In one remote monitoring study, data led to treatment changes in five of 34 patients who submitted measurements, while treatment changes were considered in another five patients.
- 2:22SPEAKER_00: Remote telemetric monitoring study.
- 2:25SPEAKER_00: Home telometry.
- 2:26SPEAKER_00: EyeCare Home 2 offers a more practical alternative for intermittent home measurements.
- 2:31SPEAKER_00: In a 75-patient prospective cohort, 65% obtained at least six measurements per day, while 19% obtained fewer than two per day.
- 2:40SPEAKER_00: The device identified maximum pressure outside clinic hours in 36% of patients.
- 2:46SPEAKER_00: Home Tonometry Cohort, Payer Position, publicly available 2026 policies from Aetna and Anthem classify continuous pressure monitoring and home telometry as investigational, unproven, or not medically necessary for routine glaucoma care.
- 3:00SPEAKER_00: Aetna policy, Anthem policy, what the devices actually measure.
- 3:05SPEAKER_00: External smart contact lenses.
- 3:08SPEAKER_00: There are two broad approaches.
- 3:10SPEAKER_00: Relative signal sensors, such as triggerfish, detect changes in corneal or corneoscleral shape that are believed to reflect pressure changes.
- 3:18SPEAKER_00: Quantitative sensors, such as the newer Purdue developed soft lenses, attempt to convert mechanical deformation into an absolute pressure estimate in millimeters of mercury.
- 3:29SPEAKER_00: This distinction is clinically important.
- 3:32SPEAKER_00: A relative signal may show that a patient's pressure-related ocular changes increased overnight, but it does not necessarily mean that a reading of higher corresponds to a specific pressure, such as 25 mm of mercury.
- 3:46SPEAKER_00: Calibration can vary with lens fit, corneal curvature, corneal thickness, posture, eyelid position, and individual ocular biomechanics.
- 3:55SPEAKER_00: Nice technology review, Triggerfish Clinical Review.
- 3:58SPEAKER_00: Implantable telemetric sensors.
- 4:00SPEAKER_00: EyeMate sensors are implanted inside the eye and are read by an external handheld or wearable reader.
- 4:07SPEAKER_00: Unlike triggerfish, the implant is designed to measure actual intraocular pressure rather than only an indirect dimensional signal.
- 4:14SPEAKER_00: The disadvantage is that implantation requires intraocular surgery, generally at the time of glaucoma or cataract surgery.
- 4:22SPEAKER_00: IMATE SC trial, IMATE IO trial, home rebound tonometry.
- 4:27SPEAKER_00: The eye care home and eye care home 2 devices do not continuously monitor pressure.
- 4:32SPEAKER_00: Instead, the patient takes individual measurements at selected times, often several times per day.
- 4:37SPEAKER_00: This makes them less passive than a contact lens but substantially easier to validate, replace, and interpret against Goldman Applination Tonometry.
- 4:46SPEAKER_00: August 2026, Contact Lens Evidence.
- 4:49SPEAKER_00: 2026, Nocturnal Soft Contact Lens.
- 4:52SPEAKER_00: The newest peer-reviewed study, published online in June 2026, evaluated a soft contact lens with an embedded wireless pressure sensor and a reader integrated into a sleep mask.
- 5:03SPEAKER_00: The design specifically addressed two limitations of earlier devices: closed eye operation and stable sensing while lying down.
- 5:11SPEAKER_00: Nocturnal Interocular Pressure Monitoring Study.
- 5:15SPEAKER_00: The study demonstrated stable sensing with the eye open and closed, monitoring during sitting and recumbent postures, resistance to moderate eye and head movement, ex vivo sensitivity of approximately 0.163 MHz per millimeter of mercury, with a calibration coefficient of R-chord equal.977.
- 5:35SPEAKER_00: Human testing in a healthy participant and a participant with pigmentary glaucoma.
- 5:39SPEAKER_00: Comfort ratings generally above 90 on the study's 0 to 100 comfort scale after transition to a recumbent eyes-closed posture.
- 5:48SPEAKER_00: No meaningful subjective visual distortion, although mild regional visual field reductions were observed in testing and remained within functional limits.
- 5:56SPEAKER_00: Advanced materials full report.
- 6:00SPEAKER_00: What the 2026 study did not show, the study did not establish, agreement with Goldman Aplination Tonometry in a clinical cohort.
- 6:09SPEAKER_00: A validated conversion equation applicable across patients.
- 6:13SPEAKER_00: Overnight wear adherence in a larger population, the percentage of usable or missing data during sleep, the sensitivity or specificity of automated alerts, treatment changes caused by sensor readings, reduced visual field loss, or slower glaucoma progression.
- 6:29SPEAKER_00: Therefore, it should be regarded as a human feasibility and engineering validation study, not as a clinical utility trial.
- 6:36SPEAKER_00: Earlier SMART soft contact lens data, A 2022 Nature Communications Study evaluated a different soft contact lens design in three adult contact lens users.
- 6:47SPEAKER_00: One participant had mild ocular hypertension.
- 6:50SPEAKER_00: The lens produced a pressure-related signal that correlated with reference measurements across different postures, with a reported calibration fit of R squared equals 0.91.
- 7:00SPEAKER_00: Its readings agreed more closely with the eye care home device and Goldman Applination Tonometry than did the Triggerfish signal in the same testing environment.
- 7:09SPEAKER_00: Smartsoft contact lens study.
- 7:11SPEAKER_00: Comfort was favorable compared with Triggerfish, although the comparison used only three participants.
- 7:17SPEAKER_00: SmartSoft lens after adaptation, 12.7 plus 5.4 on a scale where lower scores indicated less discomfort.
- 7:25SPEAKER_00: Bare soft contact lens 4.0 of 4.2.
- 7:29SPEAKER_00: Triggerfish Insertion 46.730.1.
- 7:32SPEAKER_00: Triggerfish removal 68.3 ma 6.2.
- 7:37SPEAKER_00: The authors demonstrated 24-hour monitoring in a dog, but the human component involved short-term in-clinic testing rather than overnight human monitoring.
- 7:46SPEAKER_00: No adherence, data completeness, management change, or glaucoma progression data were reported.
- 7:51SPEAKER_00: Smart Soft Contact Lens Study.
- 7:54SPEAKER_00: A United States clinical trial of smart soft contact lenses began in October 2025 and is planned to enroll approximately 120 participants, with estimated completion in September 2028.
- 8:06SPEAKER_00: As of August 18, 2026, the trial registry did not show mature clinical utility results.
- 8:12SPEAKER_00: Clinicaltrials.gov study record.
- 8:15SPEAKER_00: Correlation with Goldman Applination Tonometry.
- 8:18SPEAKER_00: Triggerfish, useful for timing, not interchangeable pressure values.
- 8:23SPEAKER_00: Triggerfish does not directly provide a conventional pressure value in millimeters of mercury.
- 8:28SPEAKER_00: Its output is an electrical signal representing changes in ocular dimensions.
- 8:33SPEAKER_00: The United States Food and Drug Administration authorized it to identify the likely time window of peak pressure so that a clinician can perform conventional measurement at a more informative time.
- 8:45SPEAKER_00: The regulatory review specifically states that treatment and diagnostic decisions should continue to rely on traditional clinical methods.
- 9:00SPEAKER_00: In a repeated 24-hour study of 40 glaucoma suspects and glaucoma patients, blurred vision occurred in 82.5%, conjunctival redness occurred in 80.0%, superficial punctate keratitis occurred in 15.0%.
- 9:17SPEAKER_00: Mean discomfort scores were approximately 27 and 24 on a 0.100 scale during two sessions.
- 9:23SPEAKER_00: The correlation between repeated pressure-related profiles was approximately 0.59, indicating fair reproducibility rather than highly precise repeatability.
- 9:34SPEAKER_00: Triggerfish Safety and Reproducibility Study.
- 9:37SPEAKER_00: The central limitation is that a reproducible relative pattern is not the same as an accurate absolute pressure measurement.
- 9:44SPEAKER_00: Lens position, corneal shape, and pressure-independent changes in ocular biomechanics can influence the signal.
- 9:51SPEAKER_00: New quantitative lenses.
- 9:53SPEAKER_00: The newer soft lenses are designed to generate absolute pressure estimates.
- 9:57SPEAKER_00: The available human evidence is encouraging, but the numbers come from very small studies.
- 10:03SPEAKER_00: The 2022 human study included only three participants, and the 2026 nocturnal study was a pilot rather than a powered diagnostic accuracy study.
- 10:13SPEAKER_00: Thus, no reliable population-level conclusion can yet be made about agreement limits, false alerts, or performance in eyes with different corneal thicknesses, prior surgery, dry eye disease, or advanced glaucoma.
- 10:27SPEAKER_00: Smart Soft Contact Lens Study.
- 10:29SPEAKER_00: Nocturnal Soft Contact Lens Study, Implantable IMATE SC.
- 10:33SPEAKER_00: The most mature quantitative wearable evidence comes from the IMATE SC implantable sensor.
- 10:39SPEAKER_00: In the initial 24-I trial, 536 sensor measurements were compared with Goldman applination telonometry.
- 10:46SPEAKER_00: The overall mean difference was 0.8 mm of Mercury.
- 10:50SPEAKER_00: The 95% limits of agreement were approximately minus 5.1 to 6.7 mm of mercury.
- 10:57SPEAKER_00: After the first three postoperative months, the mean difference was approximately minus of 0.2 millimeters of mercury.
- 11:04SPEAKER_00: All 264 measurements in that later period were within 0.5 mm of mercury of Goldman applination telonometry.
- 11:12SPEAKER_00: IMATE SC trial.
- 11:14SPEAKER_00: These results are much closer to conventional telometry than the triggerfish signal, but they come from a small, non-randomized study involving patients undergoing surgery.
- 11:23SPEAKER_00: The early postoperative period also showed greater disagreement, meaning that device readings may require a stabilization and calibration period after implantation.
- 11:33SPEAKER_00: Diurnal and nocturnal pressure patterns.
- 11:36SPEAKER_00: Why office testing misses clinically relevant peaks.
- 11:40SPEAKER_00: Goldman applination tonometry remains the reference method for routine clinical measurement.
- 11:45SPEAKER_00: However, a clinic reading is still a snapshot.
- 11:49SPEAKER_00: In a classic 24-hour applination study of 32 glaucoma patients, 69% had a peak pressure outside normal office hours.
- 11:58SPEAKER_00: Peak 24-hour pressure was higher than the previous office peak in 62% of eyes.
- 12:03SPEAKER_00: The 24-hour pressure fluctuation was larger than the office hours fluctuation.
- 12:08SPEAKER_00: The results led to immediate treatment changes in 36% of eyes.
- 12:12SPEAKER_00: Clinical utility of after hours monitoring.
- 12:15SPEAKER_00: The study was small and older, but it demonstrates the clinical rationale for seeking pressure information during sleep and outside clinic hours.
- 12:25SPEAKER_00: Triggerfish and Progression.
- 12:27SPEAKER_00: In a study of 40 treated glaucoma patients with controlled daytime pressure, 19 were classified as progressing and 21 as stable.
- 12:36SPEAKER_00: A nocturnal pressure-related peak was significantly more common among progressors than non-progressors.
- 12:42SPEAKER_00: Nocturnal triggerfish peak study.
- 12:44SPEAKER_00: A larger prospective study of 79 patients with normal tension glaucoma found that 23 showed progression over a mean follow-up of approximately 4 years.
- 12:54SPEAKER_00: A larger baseline range of daytime pressure and certain nocturnal pressure-related signal features were associated with later progression.
- 13:02SPEAKER_00: The hazard ratio for each millimeter of mercury increase in the baseline daytime range was approximately 1.23.
- 13:10SPEAKER_00: Normal tension glaucoma progression study.
- 13:13SPEAKER_00: These findings are outcome-linked associations, not proof that treating the sensor-detected pattern prevents progression.
- 13:21SPEAKER_00: The studies were observational, and clinicians cannot yet use a triggerfish curve alone to determine a treatment target.
- 13:28SPEAKER_00: Eye Care Home 2 Patterns.
- 13:31SPEAKER_00: The 2025 prospective eye care home 2 study of 75 patients found.
- 13:36SPEAKER_00: Pressure varied significantly across the 24-hour period.
- 13:39SPEAKER_00: The highest average pressure occurred around 3 a.m.
- 13:43SPEAKER_00: Average pressure declined toward a low point around 10 p.m.
- 13:46SPEAKER_00: Pressure variability was greater outside office hours.
- 13:50SPEAKER_00: 36% of patients had their maximum pressure outside clinic hours.
- 13:54SPEAKER_00: Home telometry cohort.
- 13:56SPEAKER_00: This is clinically useful because it shows that a relatively inexpensive intermittent device can reveal patterns that a normal office visit may miss.
- 14:04SPEAKER_00: It does not, however, provide continuous information while the patient is asleep.
- 14:10SPEAKER_00: 2026 Nocturnal Lens Findings.
- 14:13SPEAKER_00: The 2026 Soft Lens Study successfully detected posture-related changes during sitting, supine, lateral, and closed eye conditions.
- 14:21SPEAKER_00: That is an important technical advance because lying down in sleep may be precisely when pressure patterns differ most from daytime clinic measurements.
- 14:30SPEAKER_00: Nevertheless, the study did not establish how often those patterns occur across a glaucoma population or whether acting on them improves outcomes.
- 14:39SPEAKER_00: Advanced materials report adherence, comfort, and data completeness.
- 14:43SPEAKER_00: External contact lenses.
- 14:45SPEAKER_00: For smart contact lenses, clinical adherence data remain the largest evidence gap.
- 14:50SPEAKER_00: The 2022 soft lens study involved only three adults and measured comfort over several hours.
- 14:56SPEAKER_00: The 2026 Nocturnal Lens Study evaluated a very small human pilot.
- 15:01SPEAKER_00: Neither study reported the percentage of participants who completed a full overnight recording, the percentage of usable sensor epochs, sensor dropout during sleep, lens displacement requiring refitting, completion over repeated nights, adherence among older adults or people with advanced glaucoma.
- 15:21SPEAKER_00: Triggerfish studies generally demonstrate that patients can wear the device for a 24-hour session, but published reports do not consistently provide a clinically useful percentage of complete analyzable data.
- 15:34SPEAKER_00: A nominal full session can contain 288 five-minute recording periods, but the proportion of valid periods is not uniformly reported.
- 15:43SPEAKER_00: TriggerFish Safety and Reproducibility Study.
- 15:46SPEAKER_00: Implantable IMATE SC.
- 15:48SPEAKER_00: The 2026 three-year IMATE SC follow-up provides the best long-term patient acceptance data.
- 15:54SPEAKER_00: 21 of 24 patients completed the one-year acceptance questionnaire.
- 15:59SPEAKER_00: 16 of 24 completed the three-year questionnaire.
- 16:03SPEAKER_00: Most patients said they would seriously consider using the system at home, at work, and while traveling.
- 16:09SPEAKER_00: Daily routine disruption and foreign body sensation were reported as uncommon.
- 16:14SPEAKER_00: Vision-related quality of life remains statistically stable over three years.
- 16:18SPEAKER_00: Long-term IMAD SC acceptability study.
- 16:23SPEAKER_00: These results indicate durable acceptance, but questionnaire completion is not the same as the percentage of scheduled pressure measurements successfully completed.
- 16:32SPEAKER_00: Home tonometry.
- 16:33SPEAKER_00: The 2025 iCare Home 2 cohort provides the clearest quantitative adherence data for a non-implanted device.
- 16:41SPEAKER_00: 74 of 75 patients obtained at least one measurement.
- 16:44SPEAKER_00: 145 of 150 eyes were measured at least once.
- 16:49SPEAKER_00: The median number of measurements was 97 per patient and 49 per eye.
- 16:54SPEAKER_00: The median number was 7.4 measurements per day.
- 16:57SPEAKER_00: 65% of patients obtained at least 6 measurements per day.
- 17:01SPEAKER_00: 19% obtained fewer than two measurements per day.
- 17:04SPEAKER_00: Patients with poor adherence most often reported difficulty obtaining readings or a need for more training.
- 17:10SPEAKER_00: Home Tonometry Cohort A smaller feasibility study found that 73.7% of participants considered eye care home easy to use, and all participants obtained acceptable home pressure measurements.
- 17:24SPEAKER_00: Home monitoring feasibility study.
- 17:27SPEAKER_00: The practical lesson is that home telometry has measurable but manageable adherence problems, while overnight smart contact lenses have not yet been studied well enough to quantify their real-world completion rate.
- 17:39SPEAKER_00: Management changes triggered by device data, implantable sensor telehealth evidence.
- 17:44SPEAKER_00: The strongest evidence for remote treatment decisions comes from a multi-center study during the coronavirus disease pandemic.
- 17:52SPEAKER_00: Among 37 patients with implanted telemetric sensors, 34 patients obtained home pressure measurements.
- 17:58SPEAKER_00: A total of 8,415 measurements were collected over 370 measurement days.
- 18:05SPEAKER_00: Treatment was changed in five patients based on remote pressure data.
- 18:10SPEAKER_00: Treatment changes were considered in another five patients after clinicians received the measurements.
- 18:16SPEAKER_00: Nine of 10 participating centers judged remote monitoring to have clinical impact.
- 18:21SPEAKER_00: Remote telemetric monitoring study.
- 18:24SPEAKER_00: This demonstrates that remote pressure data can influence prescribing and reduce unnecessary visits.
- 18:30SPEAKER_00: However, the study did not use a validated automated alert algorithm, and it occurred in a highly selected group of patients who already had implanted sensors.
- 18:40SPEAKER_00: Home Tonometry and Treatment Response.
- 18:42SPEAKER_00: In a 43-I study, patients used Eye Care Home four times daily before and after selective laser treatment or medication changes.
- 18:50SPEAKER_00: Among eyes that showed at least a 20% response by Goldman applanation tonometry, Eye Care Home detected a response in 90.9% in at least one daily time period.
- 19:01SPEAKER_00: It detected a response in 45.5% across all four time periods.
- 19:07SPEAKER_00: The device also detected apparent responses in some eyes that did not show a response by Goldman applination tonometry, raising the possibility of improved sensitivity, but also the risk of false positive interpretation.
- 19:20SPEAKER_00: This study evaluated pressure response, not whether a device alert directly improved long-term vision or changed clinical outcomes.
- 19:28SPEAKER_00: Eye Care Home Therapy Response Study, Triggerfish and Treatment Changes.
- 19:33SPEAKER_00: A small early study summarized by the National Institute for Health and Care Excellence reported treatment changes in 11 patients, or 73%.
- 19:42SPEAKER_00: However, this was not a modern randomized alert-driven study.
- 19:46SPEAKER_00: Triggerfish is not authorized to independently trigger treatment decisions, and subsequent regulatory language emphasizes that conventional clinical tools should guide diagnosis and therapy.
- 19:58SPEAKER_00: Nice evidence review.
- 19:59SPEAKER_00: United States Food and Drug Administration Review.
- 20:03SPEAKER_00: New sensor-enabled interventions.
- 20:05SPEAKER_00: A July 2026 proof-of-concept study used implanted pressure sensors to measure the response to a periocular negative pressure device.
- 20:14SPEAKER_00: Seven eyes showed immediate pressure reductions.
- 20:17SPEAKER_00: Individual reductions ranged from 23% to 51% in one study and averaged approximately 20% over eight hours in another.
- 20:25SPEAKER_00: These findings demonstrate how continuous pressure data might support personalized interventions, but the studies were small, uncontrolled, and exploratory.
- 20:34SPEAKER_00: They do not establish a standard treatment pathway.
- 20:37SPEAKER_00: Periocular negative pressure study, how smart lens data should be interpreted.
- 20:43SPEAKER_00: A clinically useful system should not treat every high signal as an emergency.
- 20:48SPEAKER_00: Interpretation should include confirm the measurement type.
- 20:52SPEAKER_00: The clinician must know whether the device reports direct pressure in millimeters of mercury, a calibrated estimate, a relative ocular dimensional signal, a pressure-related waveform or pattern, trigger fish and quantitative soft contact lenses should not be interpreted in the same way.
- 21:09SPEAKER_00: Establish an individual baseline that.
- 21:12SPEAKER_00: Because lens fit and corneal biomechanics vary, the most reliable comparison may be within the same patient over time, rather than comparison with a universal population threshold.
- 21:22SPEAKER_00: Look for repeated patterns.
- 21:24SPEAKER_00: A single high reading may reflect lens displacement, eye rubbing, blinking or motion, postural change, eyelid pressure, calibration drift, poor signal quality.
- 21:34SPEAKER_00: A repeated time-linked pattern is more clinically meaningful than one isolated value.
- 21:40SPEAKER_00: Compare with conventional measurement.
- 21:43SPEAKER_00: A new device should be checked against Goldman applination tonometry or another validated clinical tonometer before treatment decisions are made.
- 21:51SPEAKER_00: This is especially important after lens fitting, surgery, medication changes, or changes in the ocular surface.
- 21:58SPEAKER_00: Link pressure data to the optimal.
- 22:00SPEAKER_00: Optic nerve.
- 22:00SPEAKER_00: Pressure data should be interpreted alongside optical coherence tomography of the retinal nerve fiber layer, visual field testing, optic nerve examination, medication history, corneal thickness and biomechanics, symptoms and recent surgery.
- 22:16SPEAKER_00: The IMAT I.O.
- 22:17SPEAKER_00: progression study is important because peak pressure and pressure fluctuation were associated with retinal nerve fiber layer thinning, whereas office mean pressure was not.
- 22:27SPEAKER_00: However, only eight eyes were analyzed, so the finding remains exploratory.
- 22:32SPEAKER_00: IMATE I.O.
- 22:33SPEAKER_00: Progression Study, Telehealth Integration, a practical remote monitoring program would require more than a sensor.
- 22:40SPEAKER_00: It would need initial in-clinic validation against Goldman applination tonometry, patient training and lens or device fitting, automatic quality checks for motion, missing readings, and calibration drift, individualized alert thresholds based on the patient's target pressure and risk profile.
- 22:58SPEAKER_00: Clinical review of trends rather than automatic medication changes.
- 23:02SPEAKER_00: A confirmation pathway for repeated abnormal readings.
- 23:06SPEAKER_00: Integration with visual field and optical coherence tomography results.
- 23:10SPEAKER_00: Defined response times for urgent versus routine alerts.
- 23:14SPEAKER_00: The iCare Home 2 platform supports transfer of home measurements to clinician-facing software, while implantable iMate studies demonstrate that remote clinicians can review large numbers of patient-generated measurements.
- 23:30SPEAKER_00: Remote telemetric monitoring study.
- 23:33SPEAKER_00: The major operational concern is alert overload.
- 23:36SPEAKER_00: If every transient pressure increase generates a notification, clinicians may receive large volumes of clinically insignificant data.
- 23:44SPEAKER_00: A safer approach would use persistent or repeated abnormalities, data quality flags, and patient-specific thresholds.
- 23:51SPEAKER_00: Comparison with standard monitoring and home tonometry.
- 23:56SPEAKER_00: For the full table, please open this article on visualfieldtest.com.
- 24:01SPEAKER_00: Goldman Applination Tonometry remains the reference standard in major glaucoma guidance, and the National Institute for Health and Care Excellence specifically notes that Triggerfish does not directly measure pressure and requires further evidence before routine management use.
- 24:16SPEAKER_00: Nice glaucoma guidance.
- 24:18SPEAKER_00: Nice triggerfish technology review.
- 24:20SPEAKER_00: Payer perspectives in the United States.
- 24:23SPEAKER_00: As of 2026, reimbursement remains a major barrier.
- 24:27SPEAKER_00: Aetna lists continuous intraocular pressure monitoring and home tonometry, including eye care home, as experimental, investigational, or unproven for glaucoma management.
- 24:37SPEAKER_00: Its policy also lists remote monitoring billing codes, but the presence of a code does not guarantee that the service is covered.
- 24:45SPEAKER_00: Aetna Glaucoma Testing Policy.
- 24:47SPEAKER_00: Anthem classifies continuous intraocular pressure monitoring as investigational and not medically necessary for all indications.
- 24:55SPEAKER_00: Its policy discusses triggerfish, IMATE, and pressure measuring contact lenses and concludes that these devices have not yet demonstrated improved health outcomes compared with standard care.
- 25:07SPEAKER_00: Anthem Continuous Monitoring Policy.
- 25:10SPEAKER_00: Triggerfish has United States marketing authorization for identifying the time window of pressure-related peaks, but that authorization is narrower than approval as a replacement for conventional telometry.
- 25:23SPEAKER_00: United States Food and Drug Administration, IMATE systems, and pressure measuring contact lenses remain subject to regulatory and coverage limitations in the United States.
- 25:33SPEAKER_00: Anthem Policy.
- 25:34SPEAKER_00: For patients, coverage is likely to depend on the exact device, whether it is being used in a clinical trial, the insurance plan, prior authorization requirements, and whether the service is billed as a device, procedure, remote monitoring service, or part of a bundled surgical episode.
- 25:51SPEAKER_00: What would establish clinical utility?
- 25:54SPEAKER_00: Before smart contact lenses become routine, studies should demonstrate at least several hundred human participants, diverse corneal shapes, thicknesses, ages, and glaucoma types, overnight wear across multiple nights, formal reporting of usable data percentage and dropout rates, agreement with Goldman applanation tonometry using bland Altman analysis.
- 26:16SPEAKER_00: Accuracy during sleep, lateral positioning, eye closure, and eye rubbing.
- 26:21SPEAKER_00: A validated alert algorithm.
- 26:23SPEAKER_00: Treatment decisions linked prospectively to device data.
- 26:26SPEAKER_00: Patient important outcomes including visual field preservation and retinal nerve fiber layer stability, cost effectiveness and staffing requirements for telehealth review.
- 26:36SPEAKER_00: Coverage and reimbursement models that do not shift excessive cost to patients.
- 26:42SPEAKER_00: Conclusion.
- 26:43SPEAKER_00: As of August 18, 2026, smart contact lenses for continuous intraocular pressure monitoring remain an important investigational technology rather than a replacement for standard glaucoma care.
- 26:56SPEAKER_00: The newest 2026 soft lens results show meaningful engineering progress.
- 27:00SPEAKER_00: Closed-eye operation, overnight-oriented design, posture-related sensing, and encouraging comfort in a very small human pilot.
- 27:09SPEAKER_00: The older triggerfish system has already shown that 24-hour pressure-related patterns can reveal nighttime peaks missed by office testing, but it does not provide a universally reliable pressure value in millimeters of mercury.
- 27:23SPEAKER_00: Implantable iMate sensors offer the strongest evidence for quantitative remote monitoring and treatment decisions, while eyeCare Home 2 provides the most practical non-implanted alternative for selected patients who can perform regular measurements.
- 27:39SPEAKER_00: The most defensible clinical role today is selective adjunctive monitoring.
- 27:44SPEAKER_00: Use conventional examination, Goldman applination tonometry, visual fields, and retinal imaging as the foundation, then use home or continuous pressure data to investigate unexplained progression, suspected nighttime pressure elevation, uncertain treatment response, or difficult telehealth situations.
- 28:02SPEAKER_00: Automated alerts should prompt clinical review, not automatic medication changes, until larger outcome-based trials establish that acting on wearable pressure data improves patient vision.
- 28:14SPEAKER_00: All links to sources are available in the text version of this article.
- 28:18SPEAKER_00: You can find the full article at VisualFieldTest.com.
- 28:23SPEAKER_00: Thanks for listening.
- 28:24SPEAKER_00: To check your visual field, click the link at the bottom of this article or visit VisualFieldTest.com.