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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Ontario
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Newmarket, Ontario, Canada, L3Y 7C5
- Clarity Eye Newmarket
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Contatto:
- Jacqueline Sun
- Numero di telefono: 4166633937
- Email: Jsun@clarityeye.ca
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Scarborough Village, Ontario, Canada, M1X 0C3
- Clarity Eye Scarborough
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Contatto:
- Jacqueline Sun
- Numero di telefono: 4166633937
- Email: Jsun@clarityeye.ca
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Vaughan, Ontario, Canada, L4K 0J4
- Clarity Eye Vaughan
-
Contatto:
- Jacqueline Sun
- Numero di telefono: 4166633937
- Email: Jsun@clarityeye.ca
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Rod Intercept Time (RIT) from Baseline to Month 1
Lasso di tempo: 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.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Rod Intercept Time (RIT) from Baseline to Month 3
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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.
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Retinal Anatomic Stability Assessed by Optical Coherence Tomography (OCT)
Lasso di tempo: 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.
|
|
Changes in Fundus Autofluorescence (FAF)
Lasso di tempo: 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.
|
Collaboratori e investigatori
Sponsor
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CLRTY-MM-IIT-2026
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
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