Relating Retinal Structural and Functional Parameters to Visual Acuity in Eyes Undergoing Treatment for Diabetic Macular Edema
This longitudinal interventional case series will utilize the patients at the University of Michigan W.K. Kellogg Eye Center scheduled to begin treatment for diabetic macular edema. Baseline measures will be taken which include structural assessments such as circulatory capacity utilizing fluorescein angiography, in addition to retinal layer integrity and thickness using high resolution optical coherence tomography. Also, functional assessments such as visual acuity, contrast sensitivity, photostress recovery, dark adaptation, perimetry, and cellular fluorescence will be tested. Adverse events will be recorded and compared with historical controls to ensure that currently accepted interventions are safe. Finally, potential confounding variables for DME including those related to the eye, systemic factors, and patient demographics will be recorded to assess the influence of these variables on treatment response.
The primary objective is to develop hypotheses that might better explain the retinal structural (anatomical) and/or functional (physiological) mechanisms of visual impairment in eyes receiving treatment for diabetic macular edema (DME).
調査の概要
状態
条件
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Michigan
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Ann Arbor、Michigan、アメリカ、48105
- Kellogg Eye Center
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-
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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Males and females age ≥ 18 years
- DME involving the central fovea (≥325 micrometers central subfield thickness on Spectralis SD-OCT)
- Scheduled to undergo treatment of DME with intravitreal bevacizumab or ranibizumab
- Willing to sign informed consent, comply with study protocol requirements, and undergo at least 2.5 hours of testing per visit;
Exclusion Criteria:
- Lens opacity ≥ grade 3 ARLNS on standard photographs
- Incisional ophthalmic surgery of any kind within 4 months of study enrollment
- Treatment for DME within the past 4 months
- Active proliferative diabetic retinopathy
- History of vitrectomy
- Glaucoma
- Uncontrolled hypertension (≥ 180 systolic or ≥ 110 diastolic on two successive measures)
- Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception throughout the study
- Females who are pregnant, lactating or breastfeeding at time of enrollment
- Subjects with a history of a serious hypersensitivity reaction to treatment or components of the study assessment
- History of any radiation in or around the eyes
- History of visually significant non-diabetic retinopathy or choroidopathy (e.g. age-related macular degeneration, polypoidal choroidal vasculopathy, central serous retinopathy, retinal vein occlusion, sickle cell retinopathy)
- History of optic neuropathy
- Neurological conditions that can impair vision (e.g. Parkinson's disease, multiple sclerosis, Alzheimer's disease)
- Liver disease (e.g. cirrhosis, hepatitis)
- History of small bowel surgery
- Anticipated need for intravitreal triamcinolone injections
- Dilated pupil diameter less than 6 millimeters
- High myopia (refractive error spherical equivalent ≥ -6 diopters)
- Currently being treated for cancer or any disease likely to adversely affect participation in a 2 year trial
- Participation in any interventional clinical study requiring IRB approval within 3 months of enrollment
- Any findings deemed unacceptable by the Principal Investigator
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
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 |
|---|---|---|
|
Dark adaptation (AdaptRx)
時間枠：12 Months
|
Rod intercept (minutes)
|
12 Months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Optical coherence tomography
時間枠：12 Months
|
Thickness of nerve fiber layer and ganglion cell layer, volume of intraretinal cysts, volume of subretinal fluid, central subfield thickness, thickness of choroid (enhanced depth imaging), status of vitreoretinal interface, presence of epiretinal membrane, status of inner segment/outer segment junction
|
12 Months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Fluorescein angiography
時間枠：12 months
|
Fluorescein transit time, foveal avascular zone (FAZ) greatest linear dimension, FAZ area, presence of perifoveal capillary loss, area of dye leakage, and microaneurysm density
|
12 months
|
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Lipofuscin fundus autofluorescence
時間枠：12 Months
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Index of retinal autofluorescence
|
12 Months
|
|
Color photographs
時間枠：12 Months
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Diabetic Retinopathy Disease Severity Scale
|
12 Months
|
|
Frequency Doubling Threshold visual field
時間枠：12 Months
|
Mean deviation, pattern standard deviation
|
12 Months
|
|
Contrast sensitivity
時間枠：12 Months
|
Log contrast sensitivity
|
12 Months
|
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Photostress test
時間枠：12 Months
|
12 Months
|
|
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Flavoprotein fluorescence
時間枠：12 Months
|
Index of metabolic fluorescence, average intensity (grey scale unit (gsu)), average curve width (GSU), heterogeneity score
|
12 Months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Grant Comer, M.D.、University of Michigan
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
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