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Overview
Canadian ophthalmology clinics evaluating device-based therapy for dry AMD should assess the same core dimensions as any other medical device adoption decision: Regulatory licensing, published evidence quality, patient eligibility criteria, treatment protocol, and post-market safety data. In Canada, the regulatory threshold is a Health Canada Medical Device Licence for the specific indication of dry AMD.
Beyond regulatory compliance, strong published clinical evidence helps an ophthalmologist communicate expected outcomes to patients with confidence. A device supported by a randomized sham-controlled trial with validated outcome measures like MacuMira provides a defensible basis for clinical recommendations.
The Ophthalmology Context for Dry AMD Device Adoption
Ophthalmologists occupy a distinct position in the dry AMD care continuum. They are typically involved when disease has progressed beyond what primary optometry monitoring can manage, when the differential diagnosis is uncertain, or when a patient needs specialist assessment of intervention eligibility. This means ophthalmologists evaluating a device-based therapy are often doing so with a patient population that skews toward more advanced disease and greater visual loss than the population seen in primary optometry.3
That context matters for device selection. The evidence base for an authorized device should be examined against the characteristics of the patients an ophthalmology practice actually sees. If the trial enrolled patients with visual acuity between 20/50 and 20/200, as in the MacuMira trial, an ophthalmologist should assess how many of their AMD patients fall within that range and calibrate both the adoption decision and the informed consent conversation accordingly.4
Ophthalmology practices also play a gatekeeping role for other clinics. An ophthalmologist who understands the evidence base for approved device therapy is well placed to make appropriate referrals to optometry practices offering the therapy, rather than leaving patients to navigate that referral pathway on their own.
Evaluation Framework for Canadian Ophthalmology Clinics
1. Health Canada Medical Device Licence
Any device used in a Canadian ophthalmology clinic for the management of dry AMD must hold a Health Canada Medical Device Licence for that specific indication. This is not a formality. It reflects Health Canada’s assessment that the device has met defined safety and efficacy standards for the approved use case.1
Ophthalmologists can request the specific Medical Device Licence number from the manufacturer and verify it independently through Health Canada’s searchable licence database. A licence covering a different indication or a broader device category does not satisfy the requirement for clinical use in treating dry AMD specifically.
The licence should also be current. Licences can be suspended or cancelled following safety concerns or significant changes to the device or its intended use. Verifying currency at the time of adoption and periodically thereafter is part of due diligence.
2. Published Clinical Evidence
The published clinical trial is the primary document an ophthalmologist should review before recommending any device to patients. Consider asking whether the trial used a randomized controlled design with a sham comparator, or whether the primary endpoints were pre-specified before data collection began. It may also be worth asking whether outcome measures are validated and clinically meaningful (e.g., ETDRS letter scores and contrast sensitivity log units), whether the analysis was conducted independently, and whether adverse event data are fully reported.2
A sham-controlled design is particularly useful in this device category because the non-specific effects of clinical attention and expectation of benefit can produce measurable apparent improvements in patient-reported outcomes. A sham control isolates the effect of the active treatment from these factors, making the measured outcomes a more reliable guide to what can genuinely be attributed to the device.
MacuMira’s published randomized sham-controlled trial reported that the treatment group showed statistically significant improvement in both visual acuity and contrast sensitivity over the treatment period. The average gain was 8.2 letters on the ETDRS scale, with 48% of treated patients gaining 10 or more letters. Contrast sensitivity improved by an average of 0.24 log units. No device-related serious adverse events were recorded in the trial, and the same safety record has been maintained across more than 21,000 treatments in real-world use across 3 countries since launch.4
3. Patient Eligibility
The trial population defines the group for whom the evidence most directly applies. Ophthalmologists should map the eligibility criteria of the device’s trial against the characteristics of their own AMD patient population before making an adoption decision.2
For MacuMira, the trial enrolled patients with dry AMD and best-corrected visual acuity between 20/50 and 20/200. Ophthalmologists whose patient population includes a significant proportion of patients with better baseline acuity than 20/50 should factor the ceiling effect into their assessment. Those patients are not necessarily poor candidates, but the consent conversation should be adjusted appropriately.4
Wet AMD patients are excluded from this indication. This is particularly relevant in practices where patients are referred specifically for wet AMD management and may also have coexisting dry AMD in the fellow eye.
4. Treatment Protocol
A device with a published treatment protocol provides a framework for consistent delivery and meaningful outcome tracking. Review the protocol in full before adoption, including the initial treatment course, the ongoing maintenance schedule, and the recommended intervals for outcome measurement.4
MacuMira’s defined schedule involves approximately 7 visits in the first year followed by around 4 visits per year thereafter. In an ophthalmology practice context, this schedule has implications for appointment capacity, staff training and patient communication. Practices should determine whether this volume of visits is manageable within their current infrastructure or whether co-management with an equipped optometry practice would be a more appropriate delivery model.4
5. Post-Market Safety Record
Post-market safety data reflects how a device performs across a broader and less controlled population than a clinical trial. For any device being considered for adoption, the treating clinician should request data on adverse events reported to Health Canada, the total number of treatments delivered since launch and the geographic spread of real-world use.4
MacuMira’s post-market record includes more than 21,000 treatments across hundreds of clinics in 3 countries with no device-related serious adverse events reported. This record, maintained over more than 2 years of real-world use, does not eliminate the need for ongoing vigilance, but it provides a basis for clinical confidence that the trial safety profile has been replicated in broader use.4
6. Integration with Specialist AMD Workflows
Device-based therapy for dry AMD is an addition to the management toolkit rather than a replacement for existing elements. Patients receiving device-based therapy should continue regular OCT monitoring, AREDS2 supplementation where indicated, and lifestyle counselling. The ophthalmologist remains responsible for disease surveillance including detection of conversion from dry to wet AMD, which requires different and more urgent treatment.3
For ophthalmology practices considering device adoption, the most important integration question is how the therapy fits into existing patient pathways. Ophthalmologists who are primarily in a referral position for dry AMD may find that a co-management model serves patients better than direct device delivery. Ophthalmologists with a larger primary AMD patient population may find in-clinic delivery more appropriate.
In either case, establishing a clear outcome monitoring protocol before beginning to offer the therapy is important. Documenting ETDRS visual acuity and contrast sensitivity at baseline and at defined intervals after treatment helps the practice assess individual patient response and provides a clinical record to support decisions about continuing or adjusting the management plan.
Informed Consent in the Ophthalmology Setting
Informed consent for device-based dry AMD therapy should cover what the device is intended to achieve, what the published evidence shows, the specific eligibility criteria and their relevance to the patient’s situation, the limitations of the therapy including what it does not do, the treatment schedule and associated costs, and the fact that the device is not indicated for wet AMD.2
Ophthalmology patients are often further along in the disease course and may have more complex expectations than patients encountering AMD management options for the first time. The consent process should be unhurried and should allow patients to ask questions about how the evidence applies to their specific situation. A patient whose visual acuity is better than the trial range or who has geographic atrophy affecting a large portion of the macula may benefit from a frank conversation about what is realistically achievable.
Questions Canadian Ophthalmology Clinics Should Ask
- What is the Health Canada Medical Device Licence number, and can I verify the specific indication it covers?1
- Can you provide the full primary trial publication rather than a summary document?2
- What are the specific patient inclusion and exclusion criteria from the trial, and are there contraindications relevant to an ophthalmology population?
- What is the complete treatment protocol including initial course, maintenance visits and outcome measurement intervals?4
- What post-market adverse event data has been submitted to Health Canada and what is the total number of treatments delivered to date?4
- What co-management models have other ophthalmology practices used, and is support available to set those arrangements up?
- What training is provided for ophthalmologists and clinic staff, and what ongoing clinical support is available?
Conclusion
Canadian ophthalmology clinics evaluating a device-based therapy for dry AMD should apply a rigorous framework covering Health Canada licensing, published trial quality, patient eligibility fit, treatment protocol, post-market safety and workflow integration.
Health Canada has authorized MacuMira to be used to improve the visual function in patients with dry AMD. It is for use under the supervision of a licensed eye care professional and is not indicated for wet AMD. Ophthalmologists should independently verify licensing, read the primary trial publication, and establish clear eligibility assessment and outcome-monitoring protocols before offering any device-based therapy.
Disclaimer
This article is for informational and educational purposes only. It does not constitute a clinical endorsement of any specific device and does not replace the professional judgment of a licensed ophthalmologist. Clinicians should apply independent assessment of the evidence when making device adoption and treatment decisions.
Glossary
Health Canada Medical Device Licence: Regulatory authorization confirming a medical device meets Canadian safety and efficacy standards for its approved indication. Required for clinical use of any regulated medical device in Canada.
MacuMira: An approved medical device indicated to improve visual function in patients with dry AMD, delivered via low-level electrical stimulation in a clinical setting under the supervision of a licensed eye care professional. Not indicated for wet AMD.
ETDRS scale: The Early Treatment Diabetic Retinopathy Study visual acuity scale, scored letter by letter. The standard outcome measure in AMD clinical trials.
Contrast sensitivity: The ability to distinguish objects from their background at varying contrast levels. Assessed as a primary outcome in dry AMD trials alongside visual acuity.
Sham-controlled trial: A clinical trial in which the control group receives a procedure that mimics the active intervention in all observable ways except the active component. The appropriate design for device efficacy trials.
Ceiling effect: In clinical measurement, the limited scope for measurable improvement when a patient’s baseline function is near the upper end of the measurement scale.
Geographic atrophy: An advanced stage of dry AMD in which large areas of retinal pigment epithelium and photoreceptors have degenerated, causing irreversible central vision loss.
Dry AMD: A progressive retinal condition affecting the macula. The most common form of AMD. Distinct from wet AMD in pathophysiology and management.
Wet AMD: A form of AMD involving abnormal blood vessel growth beneath the retina. Treated with anti-VEGF injections. Device-based therapy for dry AMD is not indicated for wet AMD.
Co-management: A clinical arrangement in which two providers share responsibility for different aspects of a patient’s care, for example, an ophthalmologist retaining diagnostic oversight while an optometrist delivers treatment sessions.
Post-market surveillance: Ongoing monitoring of a device’s safety and performance after regulatory approval through adverse event reporting and real-world outcome tracking.
References
1. Medical Device Licences. Health Canada. Date not listed. Accessed June 2026. https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/licences.html.
2. Understanding Macular Degeneration. American Academy of Ophthalmology. Published November 2025. Accessed June 2026. https://www.aao.org/eye-health/diseases/amd-macular-degeneration.
3. Age-Related Macular Degeneration (AMD). Canadian Ophthalmological Society. Date not listed. Accessed June 2026. https://www.seethepossibilities.ca/eye-health/age-related-macular-degeneration/.
4. Evaluation of visual acuity in dry AMD patients after microcurrent electrical stimulation. Parkinson KM, Sayre EC, Tobe SW. International Journal of Retina and Vitreous. Published May 2023. Accessed June 2026. https://macumira.com/wp-content/uploads/2025/07/MacuMira-Clinical-Trial.pdf.
5. Age-Related Macular Degeneration. National Eye Institute, National Institutes of Health. Last reviewed November 2023. Accessed June 2026. https://www.nei.nih.gov/eye-health-information/eye-conditions-and-diseases/age-related-macular-degeneration.
