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).
연구 개요
상태
정황
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Michigan
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Ann Arbor, Michigan, 미국, 48105
- Kellogg Eye Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Dark adaptation (AdaptRx)
기간: 12 Months
|
Rod intercept (minutes)
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12 Months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Optical coherence tomography
기간: 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
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Fluorescein angiography
기간: 12 months
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Fluorescein transit time, foveal avascular zone (FAZ) greatest linear dimension, FAZ area, presence of perifoveal capillary loss, area of dye leakage, and microaneurysm density
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12 months
|
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Lipofuscin fundus autofluorescence
기간: 12 Months
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Index of retinal autofluorescence
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12 Months
|
|
Color photographs
기간: 12 Months
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Diabetic Retinopathy Disease Severity Scale
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12 Months
|
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Frequency Doubling Threshold visual field
기간: 12 Months
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Mean deviation, pattern standard deviation
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12 Months
|
|
Contrast sensitivity
기간: 12 Months
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Log contrast sensitivity
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12 Months
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Photostress test
기간: 12 Months
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12 Months
|
|
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Flavoprotein fluorescence
기간: 12 Months
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Index of metabolic fluorescence, average intensity (grey scale unit (gsu)), average curve width (GSU), heterogeneity score
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12 Months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Grant Comer, M.D., University of Michigan
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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