ClinicalTrials.gg
Not yet recruitingNCT07917715Updated Nov 4, 2026

MacuMira Microcurrent Stimulation for Dark Adaptation in Dry Age-Related Macular Degeneration

An interventional study of Transpalpebral microcurrent electrical stimulation in Age-Related Macular Degeneration (AMD), sponsored by Clarity Eye Institute. Not yet recruiting at 3 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Clarity Eye Institute · Not applicable, Interventional, and Treatment

Updated Nov 4, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • 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
03

In context

Macular Degeneration

1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.

This study's planned enrollment of 50 is below the median of 56 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Clarity Eye Institute is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 and attend all required study visits over approximately 3 months.

Exclusion criteria

Exclusion Criteria:

  • 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).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    MacuMira Treatment

    All participants will receive four in-office sessions of transpalpebral microcurrent electrical stimulation using the MacuMira device over approximately 10 to 14 days.

    Device: Transpalpebral microcurrent electrical stimulation

Interventions

  • DeviceTranspalpebral microcurrent electrical stimulation

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Average of two baseline assessments (Screening/Baseline and Treatment Day 1) to the single assessment at Month 1.

Secondary outcomes

  1. 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.

    Time frame: Average of two baseline assessments (Screening/Baseline and Treatment Day 1) to the single assessment at Month 3.

  2. 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.

    Time frame: Baseline to the single assessment at Month 1 and the single assessment at Month 3.

  3. Change in Contrast Sensitivity

    Change in contrast sensitivity, measured using the Pelli-Robson chart, from baseline to Month 1 and Month 3.

    Time frame: Baseline to the single assessment at Month 1 and the single assessment at Month 3.

  4. 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.

    Time frame: Baseline to the single assessment at Month 1 and the single assessment at Month 3.

  5. 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.

    Time frame: Baseline to the single assessment at Month 1 and the single assessment at Month 3.

Other outcomes

  1. Retinal Anatomic Stability Assessed by Optical Coherence Tomography (OCT)

    Assessment of retinal anatomic stability using OCT, including changes in macular thickness and macular volume, from baseline to Month 1 and Month 3.

    Time frame: Baseline to the assessment at Month 1 and the assessment at Month 3.

  2. Changes in Fundus Autofluorescence (FAF)

    Assessment of changes in retinal appearance using FAF imaging from baseline to Month 1 and Month 3.

    Time frame: Baseline to the assessment at Month 1 and the assessment at Month 3.

07

Study locations

3 sites
  • Clarity Eye Newmarket
    Newmarket, Ontario L3Y 7C5, Canada
  • Clarity Eye Scarborough
    Scarborough Village, Ontario M1X 0C3, Canada
  • Clarity Eye Vaughan
    Vaughan, Ontario L4K 0J4, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07917715
Lead sponsor
Clarity Eye Institute
Collaborators
MacuMira
Responsible party
Sponsor
First posted
Nov 4, 2026
Start date
Nov 4, 2026 (estimated)
Primary completion
Aug 16, 2027 (estimated)
Completion
Oct 16, 2027 (estimated)
Last update
Nov 4, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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