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.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ontario
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Newmarket, Ontario, 캐나다, L3Y 7C5
- Clarity Eye Newmarket
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연락하다:
- Jacqueline Sun
- 전화번호: 4166633937
- 이메일: Jsun@clarityeye.ca
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Scarborough Village, Ontario, 캐나다, M1X 0C3
- Clarity Eye Scarborough
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연락하다:
- Jacqueline Sun
- 전화번호: 4166633937
- 이메일: Jsun@clarityeye.ca
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Vaughan, Ontario, 캐나다, L4K 0J4
- Clarity Eye Vaughan
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연락하다:
- Jacqueline Sun
- 전화번호: 4166633937
- 이메일: Jsun@clarityeye.ca
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Rod Intercept Time (RIT) from Baseline to Month 1
기간: Average of two baseline assessments (Screening/Baseline and Treatment Day 1) to the single assessment at Month 1.
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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.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Rod Intercept Time (RIT) from Baseline to Month 3
기간: Average of two baseline assessments (Screening/Baseline and Treatment Day 1) to the single assessment at Month 3.
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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.
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Change in Best-Corrected Visual Acuity (BCVA)
기간: Baseline to the single assessment at Month 1 and the single assessment at Month 3.
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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.
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Change in Contrast Sensitivity
기간: Baseline to the single assessment at Month 1 and the single assessment at Month 3.
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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.
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Change in Low Luminance Deficit (LLD)
기간: Baseline to the single assessment at Month 1 and the single assessment at Month 3.
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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.
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Change in Vision-Related Quality of Life
기간: Baseline to the single assessment at Month 1 and the single assessment at Month 3.
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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.
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Retinal Anatomic Stability Assessed by Optical Coherence Tomography (OCT)
기간: Baseline to the assessment at Month 1 and the assessment at Month 3.
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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)
기간: Baseline to the assessment at Month 1 and the assessment at Month 3.
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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.
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공동 작업자 및 조사자
협력자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- CLRTY-MM-IIT-2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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