MacuMira Microcurrent Stimulation for Dark Adaptation in Dry Age-Related Macular Degeneration
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Ontario
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Newmarket, Ontario, Kanada, L3Y 7C5
- Clarity Eye Newmarket
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Kontakt:
- Jacqueline Sun
- Telefonnummer: 4166633937
- E-post: Jsun@clarityeye.ca
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Scarborough Village, Ontario, Kanada, M1X 0C3
- Clarity Eye Scarborough
-
Kontakt:
- Jacqueline Sun
- Telefonnummer: 4166633937
- E-post: Jsun@clarityeye.ca
-
Vaughan, Ontario, Kanada, L4K 0J4
- Clarity Eye Vaughan
-
Kontakt:
- Jacqueline Sun
- Telefonnummer: 4166633937
- E-post: Jsun@clarityeye.ca
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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 informed consent and attend all required study visits over approximately 3 months.
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).
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Rod Intercept Time (RIT) from Baseline to Month 1
Tidsram: 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. |
Average of two baseline assessments (Screening/Baseline and Treatment Day 1) to the single assessment at Month 1.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Rod Intercept Time (RIT) from Baseline to Month 3
Tidsram: Average of two baseline assessments (Screening/Baseline and Treatment Day 1) to the single assessment at 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. |
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)
Tidsram: Baseline to the single assessment at Month 1 and the single assessment at Month 3.
|
Change in BCVA, measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart, from baseline to Month 1 and Month 3. |
Baseline to the single assessment at Month 1 and the single assessment at Month 3.
|
|
Change in Contrast Sensitivity
Tidsram: Baseline to the single assessment at Month 1 and the single assessment at Month 3.
|
Change in contrast sensitivity, measured using the Pelli-Robson chart, from baseline to Month 1 and Month 3. |
Baseline to the single assessment at Month 1 and the single assessment at Month 3.
|
|
Change in Low Luminance Deficit (LLD)
Tidsram: Baseline to the single assessment at Month 1 and the single assessment at Month 3.
|
Change in LDD from baseline to the single assessment at Month 1 and the single assessment at Month 3. |
Baseline to the single assessment at Month 1 and the single assessment at Month 3.
|
|
Change in Vision-Related Quality of Life
Tidsram: Baseline to the single assessment at Month 1 and the single assessment at Month 3.
|
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. |
Baseline to the single assessment at Month 1 and the single assessment at Month 3.
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Retinal Anatomic Stability Assessed by Optical Coherence Tomography (OCT)
Tidsram: Baseline to the assessment at Month 1 and the assessment at Month 3.
|
Assessment of retinal anatomic stability using OCT, including changes in macular thickness and macular volume, from baseline to Month 1 and Month 3. |
Baseline to the assessment at Month 1 and the assessment at Month 3.
|
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Changes in Fundus Autofluorescence (FAF)
Tidsram: Baseline to the assessment at Month 1 and the assessment at Month 3.
|
Assessment of changes in retinal appearance using FAF imaging from baseline to Month 1 and Month 3. |
Baseline to the assessment at Month 1 and the assessment at Month 3.
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CLRTY-MM-IIT-2026
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