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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Ontario
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Newmarket, Ontario, Canadá, L3Y 7C5
- Clarity Eye Newmarket
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Contacto:
- Jacqueline Sun
- Número de teléfono: 4166633937
- Correo electrónico: Jsun@clarityeye.ca
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Scarborough Village, Ontario, Canadá, M1X 0C3
- Clarity Eye Scarborough
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Contacto:
- Jacqueline Sun
- Número de teléfono: 4166633937
- Correo electrónico: Jsun@clarityeye.ca
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Vaughan, Ontario, Canadá, L4K 0J4
- Clarity Eye Vaughan
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Contacto:
- Jacqueline Sun
- Número de teléfono: 4166633937
- Correo electrónico: Jsun@clarityeye.ca
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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. |
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Rod Intercept Time (RIT) from Baseline to Month 1
Periodo de tiempo: 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.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Rod Intercept Time (RIT) from Baseline to Month 3
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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.
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Retinal Anatomic Stability Assessed by Optical Coherence Tomography (OCT)
Periodo de tiempo: 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)
Periodo de tiempo: 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.
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CLRTY-MM-IIT-2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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