Visual Function Metrics in Early and Intermediate Dry Age-related Macular Degeneration for Use as Clinical Trial Endpoints

To evaluate and quantify visual function metrics to be used as endpoints of age-related macular degeneration (AMD) stages and visual acuity (VA) loss in patients with early and intermediate AMD. Cross-sectional analysis of baseline data from a prospective study. One hundred and one patients were enr...

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Vydané v:	American journal of ophthalmology Ročník 189; s. 127 - 138
Hlavní autori:	Cocce, Kimberly J., Stinnett, Sandra S., Luhmann, Ulrich F.O., Vajzovic, Lejla, Horne, Anupama, Schuman, Stefanie G., Toth, Cynthia A., Cousins, Scott W., Lad, Eleonora M.
Médium:	Journal Article
Jazyk:	English
Vydavateľské údaje:	United States Elsevier Inc 01.05.2018 Elsevier Limited
Predmet:	Age Aged Aged, 80 and over Cataracts Clinical trials Consent Contrast Sensitivity Cross-Sectional Studies Dark Adaptation - physiology Diabetic retinopathy Endpoint Determination Eye diseases Family medical history Female Geographic Atrophy - classification Geographic Atrophy - diagnosis Humans Lighting Macular degeneration Male Middle Aged Ophthalmology Prospective Studies Visual Acuity - physiology Visual Field Tests Visual Fields - physiology United States > US
ISSN:	0002-9394, 1879-1891, 1879-1891
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Abstract	To evaluate and quantify visual function metrics to be used as endpoints of age-related macular degeneration (AMD) stages and visual acuity (VA) loss in patients with early and intermediate AMD. Cross-sectional analysis of baseline data from a prospective study. One hundred and one patients were enrolled at Duke Eye Center: 80 patients with early AMD (Age-Related Eye Disease Study [AREDS] stage 2 [n = 33] and intermediate stage 3 [n = 47]) and 21 age-matched, normal controls. A dilated retinal examination, macular pigment optical density measurements, and several functional assessments (best-corrected visual acuity, macular integrity assessment mesopic microperimety, dark adaptometry, low-luminance visual acuity [LLVA] [standard using a log 2.0 neutral density filter and computerized method], and cone contrast test [CCT]) were performed. Low-luminance deficit (LLD) was defined as the difference in numbers of letters read at standard vs low luminance. Group comparisons were performed to evaluate differences between the control and the early and intermediate AMD groups using 2-sided significance tests. Functional measures that significantly distinguished between normal and intermediate AMD were standard and computerized (0.5 cd/m2) LLVA, percent reduced threshold and average threshold on microperimetry, CCTs, and rod intercept on dark adaptation (P < .05). The intermediate group demonstrated deficits in microperimetry reduced threshhold, computerized LLD2, and dark adaptation (P < .05) relative to early AMD. Our study suggests that LLVA, microperimetry, CCT, and dark adaptation may serve as functional measures differentiating early-to-intermediate stages of dry AMD.
AbstractList	To evaluate and quantify visual function metrics to be used as endpoints of age-related macular degeneration (AMD) stages and visual acuity (VA) loss in patients with early and intermediate AMD. Cross-sectional analysis of baseline data from a prospective study. One hundred and one patients were enrolled at Duke Eye Center: 80 patients with early AMD (Age-Related Eye Disease Study [AREDS] stage 2 [n = 33] and intermediate stage 3 [n = 47]) and 21 age-matched, normal controls. A dilated retinal examination, macular pigment optical density measurements, and several functional assessments (best-corrected visual acuity, macular integrity assessment mesopic microperimety, dark adaptometry, low-luminance visual acuity [LLVA] [standard using a log 2.0 neutral density filter and computerized method], and cone contrast test [CCT]) were performed. Low-luminance deficit (LLD) was defined as the difference in numbers of letters read at standard vs low luminance. Group comparisons were performed to evaluate differences between the control and the early and intermediate AMD groups using 2-sided significance tests. Functional measures that significantly distinguished between normal and intermediate AMD were standard and computerized (0.5 cd/m ) LLVA, percent reduced threshold and average threshold on microperimetry, CCTs, and rod intercept on dark adaptation (P < .05). The intermediate group demonstrated deficits in microperimetry reduced threshhold, computerized LLD2, and dark adaptation (P < .05) relative to early AMD. Our study suggests that LLVA, microperimetry, CCT, and dark adaptation may serve as functional measures differentiating early-to-intermediate stages of dry AMD. To evaluate and quantify visual function metrics to be used as endpoints of age-related macular degeneration (AMD) stages and visual acuity (VA) loss in patients with early and intermediate AMD. Cross-sectional analysis of baseline data from a prospective study. One hundred and one patients were enrolled at Duke Eye Center: 80 patients with early AMD (Age-Related Eye Disease Study [AREDS] stage 2 [n = 33] and intermediate stage 3 [n = 47]) and 21 age-matched, normal controls. A dilated retinal examination, macular pigment optical density measurements, and several functional assessments (best-corrected visual acuity, macular integrity assessment mesopic microperimety, dark adaptometry, low-luminance visual acuity [LLVA] [standard using a log 2.0 neutral density filter and computerized method], and cone contrast test [CCT]) were performed. Low-luminance deficit (LLD) was defined as the difference in numbers of letters read at standard vs low luminance. Group comparisons were performed to evaluate differences between the control and the early and intermediate AMD groups using 2-sided significance tests. Functional measures that significantly distinguished between normal and intermediate AMD were standard and computerized (0.5 cd/m2) LLVA, percent reduced threshold and average threshold on microperimetry, CCTs, and rod intercept on dark adaptation (P < .05). The intermediate group demonstrated deficits in microperimetry reduced threshhold, computerized LLD2, and dark adaptation (P < .05) relative to early AMD. Our study suggests that LLVA, microperimetry, CCT, and dark adaptation may serve as functional measures differentiating early-to-intermediate stages of dry AMD. To evaluate and quantify visual function metrics to be used as endpoints of age-related macular degeneration (AMD) stages and visual acuity (VA) loss in patients with early and intermediate AMD.PURPOSETo evaluate and quantify visual function metrics to be used as endpoints of age-related macular degeneration (AMD) stages and visual acuity (VA) loss in patients with early and intermediate AMD.Cross-sectional analysis of baseline data from a prospective study.DESIGNCross-sectional analysis of baseline data from a prospective study.One hundred and one patients were enrolled at Duke Eye Center: 80 patients with early AMD (Age-Related Eye Disease Study [AREDS] stage 2 [n = 33] and intermediate stage 3 [n = 47]) and 21 age-matched, normal controls. A dilated retinal examination, macular pigment optical density measurements, and several functional assessments (best-corrected visual acuity, macular integrity assessment mesopic microperimety, dark adaptometry, low-luminance visual acuity [LLVA] [standard using a log 2.0 neutral density filter and computerized method], and cone contrast test [CCT]) were performed. Low-luminance deficit (LLD) was defined as the difference in numbers of letters read at standard vs low luminance. Group comparisons were performed to evaluate differences between the control and the early and intermediate AMD groups using 2-sided significance tests.METHODSOne hundred and one patients were enrolled at Duke Eye Center: 80 patients with early AMD (Age-Related Eye Disease Study [AREDS] stage 2 [n = 33] and intermediate stage 3 [n = 47]) and 21 age-matched, normal controls. A dilated retinal examination, macular pigment optical density measurements, and several functional assessments (best-corrected visual acuity, macular integrity assessment mesopic microperimety, dark adaptometry, low-luminance visual acuity [LLVA] [standard using a log 2.0 neutral density filter and computerized method], and cone contrast test [CCT]) were performed. Low-luminance deficit (LLD) was defined as the difference in numbers of letters read at standard vs low luminance. Group comparisons were performed to evaluate differences between the control and the early and intermediate AMD groups using 2-sided significance tests.Functional measures that significantly distinguished between normal and intermediate AMD were standard and computerized (0.5 cd/m2) LLVA, percent reduced threshold and average threshold on microperimetry, CCTs, and rod intercept on dark adaptation (P < .05). The intermediate group demonstrated deficits in microperimetry reduced threshhold, computerized LLD2, and dark adaptation (P < .05) relative to early AMD.RESULTSFunctional measures that significantly distinguished between normal and intermediate AMD were standard and computerized (0.5 cd/m2) LLVA, percent reduced threshold and average threshold on microperimetry, CCTs, and rod intercept on dark adaptation (P < .05). The intermediate group demonstrated deficits in microperimetry reduced threshhold, computerized LLD2, and dark adaptation (P < .05) relative to early AMD.Our study suggests that LLVA, microperimetry, CCT, and dark adaptation may serve as functional measures differentiating early-to-intermediate stages of dry AMD.CONCLUSIONSOur study suggests that LLVA, microperimetry, CCT, and dark adaptation may serve as functional measures differentiating early-to-intermediate stages of dry AMD. PurposeTo evaluate and quantify visual function metrics to be used as endpoints of age-related macular degeneration (AMD) stages and visual acuity (VA) loss in patients with early and intermediate AMD.DesignCross-sectional analysis of baseline data from a prospective study.MethodsOne hundred and one patients were enrolled at Duke Eye Center: 80 patients with early AMD (Age-Related Eye Disease Study [AREDS] stage 2 [n = 33] and intermediate stage 3 [n = 47]) and 21 age-matched, normal controls. A dilated retinal examination, macular pigment optical density measurements, and several functional assessments (best-corrected visual acuity, macular integrity assessment mesopic microperimety, dark adaptometry, low-luminance visual acuity [LLVA] [standard using a log 2.0 neutral density filter and computerized method], and cone contrast test [CCT]) were performed. Low-luminance deficit (LLD) was defined as the difference in numbers of letters read at standard vs low luminance. Group comparisons were performed to evaluate differences between the control and the early and intermediate AMD groups using 2-sided significance tests.ResultsFunctional measures that significantly distinguished between normal and intermediate AMD were standard and computerized (0.5 cd/m2) LLVA, percent reduced threshold and average threshold on microperimetry, CCTs, and rod intercept on dark adaptation (P < .05). The intermediate group demonstrated deficits in microperimetry reduced threshhold, computerized LLD2, and dark adaptation (P < .05) relative to early AMD.ConclusionsOur study suggests that LLVA, microperimetry, CCT, and dark adaptation may serve as functional measures differentiating early-to-intermediate stages of dry AMD.
Author	Luhmann, Ulrich F.O. Horne, Anupama Toth, Cynthia A. Cousins, Scott W. Lad, Eleonora M. Cocce, Kimberly J. Vajzovic, Lejla Stinnett, Sandra S. Schuman, Stefanie G.
AuthorAffiliation	2 Roche Pharmaceutical Research and Early Development, Translational Medicine Neuroscience & Ophthalmology & Rare Diseases Biomarkers, Roche Innovation Center Basel 1 Department of Ophthalmology, Duke University Medical Center. 2351 Erwin Rd, Durham, North Carolina 27705
AuthorAffiliation_xml	– name: 2 Roche Pharmaceutical Research and Early Development, Translational Medicine Neuroscience & Ophthalmology & Rare Diseases Biomarkers, Roche Innovation Center Basel – name: 1 Department of Ophthalmology, Duke University Medical Center. 2351 Erwin Rd, Durham, North Carolina 27705
Author_xml	– sequence: 1 givenname: Kimberly J. orcidid: 0000-0001-8435-521X surname: Cocce fullname: Cocce, Kimberly J. organization: Department of Ophthalmology, Duke University Medical Center, Durham, North Carolina – sequence: 2 givenname: Sandra S. surname: Stinnett fullname: Stinnett, Sandra S. organization: Department of Ophthalmology, Duke University Medical Center, Durham, North Carolina – sequence: 3 givenname: Ulrich F.O. surname: Luhmann fullname: Luhmann, Ulrich F.O. organization: Roche Pharmaceutical Research and Early Development, Translational Medicine Neuroscience & Ophthalmology & Rare Diseases Biomarkers, Roche Innovation Center Basel, Basel, Switzerland – sequence: 4 givenname: Lejla surname: Vajzovic fullname: Vajzovic, Lejla organization: Department of Ophthalmology, Duke University Medical Center, Durham, North Carolina – sequence: 5 givenname: Anupama surname: Horne fullname: Horne, Anupama organization: Department of Ophthalmology, Duke University Medical Center, Durham, North Carolina – sequence: 6 givenname: Stefanie G. surname: Schuman fullname: Schuman, Stefanie G. organization: Department of Ophthalmology, Duke University Medical Center, Durham, North Carolina – sequence: 7 givenname: Cynthia A. surname: Toth fullname: Toth, Cynthia A. organization: Department of Ophthalmology, Duke University Medical Center, Durham, North Carolina – sequence: 8 givenname: Scott W. surname: Cousins fullname: Cousins, Scott W. organization: Department of Ophthalmology, Duke University Medical Center, Durham, North Carolina – sequence: 9 givenname: Eleonora M. surname: Lad fullname: Lad, Eleonora M. email: nora.lad@duke.edu organization: Department of Ophthalmology, Duke University Medical Center, Durham, North Carolina
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/29477964$$D View this record in MEDLINE/PubMed
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Snippet	To evaluate and quantify visual function metrics to be used as endpoints of age-related macular degeneration (AMD) stages and visual acuity (VA) loss in... PurposeTo evaluate and quantify visual function metrics to be used as endpoints of age-related macular degeneration (AMD) stages and visual acuity (VA) loss in...
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SubjectTerms	Age Aged Aged, 80 and over Cataracts Clinical trials Consent Contrast Sensitivity Cross-Sectional Studies Dark Adaptation - physiology Diabetic retinopathy Endpoint Determination Eye diseases Family medical history Female Geographic Atrophy - classification Geographic Atrophy - diagnosis Humans Lighting Macular degeneration Male Middle Aged Ophthalmology Prospective Studies Visual Acuity - physiology Visual Field Tests Visual Fields - physiology
Title	Visual Function Metrics in Early and Intermediate Dry Age-related Macular Degeneration for Use as Clinical Trial Endpoints
URI	https://www.clinicalkey.com/#!/content/1-s2.0-S0002939418300709 https://dx.doi.org/10.1016/j.ajo.2018.02.012 https://www.ncbi.nlm.nih.gov/pubmed/29477964 https://www.proquest.com/docview/2028117519 https://www.proquest.com/docview/2008367000 https://pubmed.ncbi.nlm.nih.gov/PMC6043161
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