Age-Related Macular Degeneration (AMD)NCT07917715
MacuMira Microcurrent Stimulation for Dark Adaptation in Dry Age-Related Macular Degeneration
A study testing Transpalpebral microcurrent electrical stimulation in people with Age-Related Macular Degeneration (AMD), run by Clarity Eye Institute at 3 sites in Canada.
Trial summary
Age-related macular degeneration (AMD) is an eye condition that affects the retina and can lead to progressive vision loss. This study will evaluate the effects of MacuMira microcurrent stimulation on dark adaptation in adults with intermediate dry AMD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Age-Related Macular Degeneration (AMD)
- What is being tested?
- Transpalpebral microcurrent electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesCanada
- Study dates
- 4 Nov 2026to 16 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 years of age.
- Diagnosis of intermediate nonexudative age-related macular degeneration (AMD), according to the Beckman Classification.
- Preliminary best-corrected visual acuity (BCVA) of 20/30 to 20/100 in the study eye.
- Ability to provide informed consent and attend all required study visits over approximately 3 months.
Who cannot join
- Presence of neovascular (wet) AMD or other macular or retinal diseases, including epiretinal membrane (ERM) or diabetic retinopathy.
- Presence of geographic atrophy.
- Intolerability to MacuMira treatment.
- Baseline Rod Intercept Time (RIT) outside the eligibility range of 8.5 to 30 minutes.
- Presence of other ocular or systemic conditions that may confound central visual function (e.g., advanced glaucoma or optic neuritis) or study assessments (e.g., dementia).
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada3 sites
Clarity Eye Newmarket
Newmarket, Ontario, L3Y 7C5
Jacqueline Sun, 4166633937, Jsun@clarityeye.ca
Clarity Eye Scarborough
Scarborough Village, Ontario, M1X 0C3
Jacqueline Sun, 4166633937, Jsun@clarityeye.ca
Clarity Eye Vaughan
Vaughan, Ontario, L4K 0J4
Jacqueline Sun, 4166633937, Jsun@clarityeye.ca
About this study
Official title: MacuMira Microcurrent Electrical Stimulation and Dark Adaptation in Dry Age-Related Macular Degeneration
Age-related macular degeneration (AMD) is an eye condition that affects the retina and can lead to progressive vision loss. This study will evaluate the effects of MacuMira microcurrent stimulation on dark adaptation in adults with intermediate dry AMD.
Participants will receive four in-office treatment sessions over 10 to 14 days. Dark adaptation and other measures of visual function and retinal health will be assessed before treatment and at one and three months after treatment.
- Conditions
- Age-Related Macular Degeneration (AMD)
- Being tested
- Transpalpebral microcurrent electrical stimulation
- Keywords
- Intermediate dry age-related macular degeneration, Dark adaptation, Rod Intercept Time, Microcurrent electrical stimulation, Transpalpebral stimulation, MacuMira, AdaptDx Pro
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transpalpebral microcurrent electrical stimulationDevice
Four in-office sessions of transpalpebral microcurrent electrical stimulation using the MacuMira device. The first treatment session will occur within 7 days of screening/baseline, with the remaining sessions administered over approximately 10 to 14 days.
| Study group | Role | What they receive |
|---|---|---|
| MacuMira Treatment | Experimental | All participants will receive four in-office sessions of transpalpebral microcurrent electrical stimulation using the MacuMira device over approximately 10 to 14 days. Receives: Device: Transpalpebral microcurrent electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Rod Intercept Time (RIT) from Baseline to Month 1
Change in RIT, measured using the AdaptDx Pro dark adaptation test, from the average of two baseline assessments to the single RIT assessment at Month 1. The two baseline measurements will be obtained at the Screening/Baseline visit and Treatment Day 1, prior to the first MacuMira treatment, and averaged to establish baseline RIT. Each eligible eye will be assessed separately.
Measured: Average of two baseline assessments (Screening/Baseline and Treatment Day 1) to the single assessment at Month 1.
Secondary outcomes (5)
Change in Rod Intercept Time (RIT) from Baseline to Month 3
Change in RIT, measured using the AdaptDx Pro dark adaptation test, from the average of two baseline assessments to the single RIT assessment at Month 3. Each eligible eye will be assessed separately.
Measured: Average of two baseline assessments (Screening/Baseline and Treatment Day 1) to the single assessment at Month 3.
Change in Best-Corrected Visual Acuity (BCVA)
Change in BCVA, measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart, from baseline to Month 1 and Month 3.
Measured: Baseline to the single assessment at Month 1 and the single assessment at Month 3.
Change in Contrast Sensitivity
Change in contrast sensitivity, measured using the Pelli-Robson chart, from baseline to Month 1 and Month 3.
Measured: Baseline to the single assessment at Month 1 and the single assessment at Month 3.
Change in Low Luminance Deficit (LLD)
Change in LDD from baseline to the single assessment at Month 1 and the single assessment at Month 3.
Measured: Baseline to the single assessment at Month 1 and the single assessment at Month 3.
Change in Vision-Related Quality of Life
Change in vision-related quality of life, measured using the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25), from baseline to the single assessment at Month 1 and the single assessment at Month 3.
Measured: Baseline to the single assessment at Month 1 and the single assessment at Month 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start4 Nov 2026 (estimated)
- Primary completion16 Aug 2027 (estimated)
- Study completion16 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular Degeneration (AMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clarity Eye Institute
- Sponsor type
- University, hospital or other
- Collaborators
- MacuMira
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917715
- Sponsor's protocol ID
- CLRTY-MM-IIT-2026
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MacuMira Microcurrent Electrical Stimulation and Dark Adaptation in Dry Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT07917715
- Acronym / sponsor ID
- CLRTY-MM-IIT-2026
- Conditions
- Age-Related Macular Degeneration (AMD)
- Keywords
- Intermediate dry age-related macular degeneration, Dark adaptation, Rod Intercept Time, Microcurrent electrical stimulation, Transpalpebral stimulation, MacuMira, AdaptDx Pro
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Clarity Eye InstituteUniversity, hospital or other
- Collaborators
- MacuMira
- Study start
- 4 Nov 2026 (estimated)
- Primary completion
- 16 Aug 2027 (estimated)
- Study completion
- 16 Oct 2027 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Age-related macular degeneration (AMD) is an eye condition that affects the retina and can lead to progressive vision loss. This study will evaluate the effects of MacuMira microcurrent stimulation on dark adaptation in adults with intermediate dry AMD.
Participants will receive four in-office treatment sessions over 10 to 14 days. Dark adaptation and other measures of visual function and retinal health will be assessed before treatment and at one and three months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MacuMira Treatment | Experimental | Device: Transpalpebral microcurrent electrical stimulationAll participants will receive four in-office sessions of transpalpebral microcurrent electrical stimulation using the MacuMira device over approximately 10 to 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults ≥18 years of age.
- Diagnosis of intermediate nonexudative age-related macular degeneration (AMD), according to the Beckman Classification.
- Preliminary best-corrected visual acuity (BCVA) of 20/30 to 20/100 in the study eye.
- Ability to provide informed consent and attend all required study visits over approximately 3 months.
Key exclusion criteria (5 listed)
- Presence of neovascular (wet) AMD or other macular or retinal diseases, including epiretinal membrane (ERM) or diabetic retinopathy.
- Presence of geographic atrophy.
- Intolerability to MacuMira treatment.
- Baseline Rod Intercept Time (RIT) outside the eligibility range of 8.5 to 30 minutes.
- Presence of other ocular or systemic conditions that may confound central visual function (e.g., advanced glaucoma or optic neuritis) or study assessments (e.g., dementia).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transpalpebral microcurrent electrical stimulationFour in-office sessions of transpalpebral microcurrent electrical stimulation using the MacuMira device. The first treatment session will occur within 7 days of screening/baseline, with the remaining sessions administered over approximately 10 to 14 days. | Device | MacuMira Treatment |
Primary outcome
Change in Rod Intercept Time (RIT) from Baseline to Month 1
Time frame: Average of two baseline assessments (Screening/Baseline and Treatment Day 1) to the single assessment at Month 1.
Change in RIT, measured using the AdaptDx Pro dark adaptation test, from the average of two baseline assessments to the single RIT assessment at Month 1. The two baseline measurements will be obtained at the Screening/Baseline visit and Treatment Day 1, prior to the first MacuMira treatment, and averaged to establish baseline RIT. Each eligible eye will be assessed separately.
5 secondary outcomes
Change in Rod Intercept Time (RIT) from Baseline to Month 3
Time frame: Average of two baseline assessments (Screening/Baseline and Treatment Day 1) to the single assessment at Month 3.
Change in Best-Corrected Visual Acuity (BCVA)
Time frame: Baseline to the single assessment at Month 1 and the single assessment at Month 3.
Change in Contrast Sensitivity
Time frame: Baseline to the single assessment at Month 1 and the single assessment at Month 3.
Change in Low Luminance Deficit (LLD)
Time frame: Baseline to the single assessment at Month 1 and the single assessment at Month 3.
Change in Vision-Related Quality of Life
Time frame: Baseline to the single assessment at Month 1 and the single assessment at Month 3.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transpalpebral microcurrent electrical stimulation in people with Age-Related Macular Degeneration (AMD), run by Clarity Eye Institute at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Rod Intercept Time (RIT) from Baseline to Month 1 (time frame: Average of two baseline assessments (Screening/Baseline and Treatment Day 1) to the single assessment at Month 1.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.