Secondary and Exploratory Outcomes of the Subthreshold Nanosecond Laser Intervention Randomized Trial in Age-Related Macular Degeneration: A LEAD Study Report

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dc.contributor.authorWu, Z.
dc.contributor.authorLuu, C.D.
dc.contributor.authorHodgson, L.A.B.
dc.contributor.authorCaruso, E.
dc.contributor.authorBrassington, K.H.
dc.contributor.authorTindill, N.
dc.contributor.authorAung, K.Z.
dc.contributor.authorHarper, C.A.
dc.contributor.authorWickremasinghe, S.S.
dc.contributor.authorSandhu, S.S.
dc.contributor.authorMcGuinness, M.B.
dc.contributor.authorChen, F.K.
dc.contributor.authorChakravarthy, U.
dc.contributor.authorArnold, J.J.
dc.contributor.authorHeriot, W.J.
dc.contributor.authorDurkin, S.R.
dc.contributor.authorWintergerst, M.W.M.
dc.contributor.authorGorgi Zadeh, S.
dc.contributor.authorSchultz, T.
dc.contributor.authorFinger, R.P.
dc.contributor.authoret al.
dc.date.issued2019
dc.description.abstractPurpose:To evaluate the secondary and exploratory outcomesof the Laser Intervention in Early Stages of Age-Related MacularDegeneration (LEAD) study, a 36-month trial of a subthresholdnanosecond laser (SNL) treatment for slowing the progression tolate age-related macular degeneration (AMD) in its early stages.Design:Multicenter, randomized, sham-controlled trial.Participants:Two-hundred ninety-two patients with bilaterallarge drusen.Methods:Participants were randomly assigned to receive SNLor sham treatment to the study eye at 6-month intervals.Main Outcome Measures:The secondary outcome measure ofthe LEAD study was the time to development of late AMD, definedby multimodal imaging in the nonestudy eye. The exploratoryoutcome measures were the rate of change in best-corrected visualacuity (BCVA), low-luminance visual acuity, microperimetric meansensitivity, drusen volume in the study and nonestudy eyes, andparticipant-reported outcomes based on the Night Vision Question-naire and Impact of Vision Impairment questionnaire.Results:Progression to late AMD in the nonestudy eye wasnot significantly delayed with SNL treatment (hazard ratio, 0.83;95% confidence interval, 0.40e1.71;P¼0.611). There was noevidence of effect modification based on the coexistence of retic-ular pseudodrusen; interactionP¼0.065). There was no signifi-cant difference between study groups in the rate of change of low-luminance visual acuity, microperimetric mean sensitivity, anddrusen volume in the study or nonestudy eyes, and Night VisionQuestionnaire and Impact of Vision Impairment questionnaire2 scores (allP 0.167). The rate of BCVA decline was slightlyhigher for participants in the SNL group compared with the shamtreatment group in the study eye (e0.54 and 0.23 letters/year,respectively;P<0.001) but not the nonestudy eye (e0.48 ande0.56 letters/year, respectively;P¼0.628).Conclusions:Subthreshold nanosecond laser treatment of oneeye did not have an effect on delaying progression to late AMD in thefellow eye and did not, in general, have an impact on the exploratorystructural, functional, and participant-reported outcomes.
dc.description.statementofresponsibilityZhichao Wu, Chi D. Luu, Lauren A.B. Hodgson, Emily Caruso, Kate H. Brassington, Nicole Tindill, Khin Zaw Aung, Colin A. Harper, Sanjeewa S. Wickremasinghe, Sukhpal S. Sandhu, Myra B. McGuinness, Fred K. Chen, Usha Chakravarthy, Jennifer J. Arnold, Wilson J. Heriot, Shane R. Durkin, Maximilian W.M. Wintergerst, Shekoufeh Gorgi Zadeh, Thomas Schultz, Robert P.Finger, Amy C. Cohn, Elizabeth K.Baglin, Pyrawy Sharangan, Robyn H. Guymer, for the LEAD Study Group
dc.identifier.citationOphthalmology Retina, 2019; 3(12):1026-1034
dc.identifier.doi10.1016/j.oret.2019.07.008
dc.identifier.issn2468-6530
dc.identifier.issn2468-6530
dc.identifier.urihttps://hdl.handle.net/2440/133497
dc.language.isoen
dc.publisherElsevier
dc.relation.granthttp://purl.org/au-research/grants/nhmrc/1027624
dc.relation.granthttp://purl.org/au-research/grants/nhmrc/GNT1103013
dc.relation.granthttp://purl.org/au-research/grants/nhmrc/1104985
dc.relation.granthttp://purl.org/au-research/grants/nhmrc/1054712
dc.relation.granthttp://purl.org/au-research/grants/nhmrc/1142962
dc.relation.granthttp://purl.org/au-research/grants/nhmrc/GNT1128343
dc.rights© 2019 by the American Academy of Ophthalmology
dc.source.urihttps://doi.org/10.1016/j.oret.2019.07.008
dc.subjectLEAD Study Group
dc.subjectFundus Oculi
dc.subjectMacula Lutea
dc.subjectHumans
dc.subjectMacular Degeneration
dc.subjectRetinal Drusen
dc.subjectFluorescein Angiography
dc.subjectTreatment Outcome
dc.subjectFollow-Up Studies
dc.subjectVisual Acuity
dc.subjectAged
dc.subjectAged, 80 and over
dc.subjectMiddle Aged
dc.subjectFemale
dc.subjectMale
dc.subjectLaser Therapy
dc.subject.meshFundus Oculi
dc.subject.meshMacula Lutea
dc.subject.meshHumans
dc.subject.meshMacular Degeneration
dc.subject.meshRetinal Drusen
dc.subject.meshFluorescein Angiography
dc.subject.meshTreatment Outcome
dc.subject.meshFollow-Up Studies
dc.subject.meshVisual Acuity
dc.subject.meshAged
dc.subject.meshAged, 80 and over
dc.subject.meshMiddle Aged
dc.subject.meshFemale
dc.subject.meshMale
dc.subject.meshLaser Therapy
dc.titleSecondary and Exploratory Outcomes of the Subthreshold Nanosecond Laser Intervention Randomized Trial in Age-Related Macular Degeneration: A LEAD Study Report
dc.typeJournal article
pubs.publication-statusPublished

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