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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Ontario
-
Newmarket、Ontario、カナダ、L3Y 7C5
- Clarity Eye Newmarket
-
コンタクト：
- Jacqueline Sun
- 電話番号：4166633937
- メール：Jsun@clarityeye.ca
-
Scarborough Village、Ontario、カナダ、M1X 0C3
- Clarity Eye Scarborough
-
コンタクト：
- Jacqueline Sun
- 電話番号：4166633937
- メール：Jsun@clarityeye.ca
-
Vaughan、Ontario、カナダ、L4K 0J4
- Clarity Eye Vaughan
-
コンタクト：
- Jacqueline Sun
- 電話番号：4166633937
- メール：Jsun@clarityeye.ca
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Rod Intercept Time (RIT) from Baseline to Month 1
時間枠：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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Rod Intercept Time (RIT) from Baseline to Month 3
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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.
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Retinal Anatomic Stability Assessed by Optical Coherence Tomography (OCT)
時間枠：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)
時間枠：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.
|
協力者と研究者
スポンサー
協力者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- CLRTY-MM-IIT-2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。