PMID- 33637858
OWN - NLM
STAT- MEDLINE
DCOM- 20211215
LR  - 20211215
IS  - 2045-2322 (Electronic)
IS  - 2045-2322 (Linking)
VI  - 11
IP  - 1
DP  - 2021 Feb 26
TI  - Improved sensitivity of microperimetric outcomes for clinical studies in 
      age-related macular degeneration.
PG  - 4764
LID - 10.1038/s41598-021-83716-w [doi]
LID - 4764
AB  - To investigate sensitive outcome measures based exclusively on abnormal points in 
      microperimetry testing of eyes with intermediate age-related macular degeneration 
      (iAMD). 25 eyes of 25 subjects with iAMD had undergone 2 successive tests of 
      mesopic microperimetry with the Macular Integrity Assessment Microperimeter 
      (MAIA), using a custom grid of 33 points spanning the central 14 degrees of the 
      macula. Each point was defined as abnormal if its threshold sensitivity was lower 
      than 1.65 standard deviations (SD) (5%) or 2 SD (2.5%) than the expected 
      threshold in healthy eyes according to the MAIA internal database. Among the 25 
      eyes there were 11.8 +/- 9 and 8.4 +/- 8.2 abnormal points at < 5% and < 2.5%, with 
      mean deviation of thresholds from normal - 4.9 +/- 1.2 dB and - 5.8 +/- 1.5 dB, 
      respectively. These deviations were greater, and their SD smaller, compared with 
      the complete microperimetry grid, - 2.3 +/- 2.0 dB. The 95% limits of agreement for 
      average threshold between the 2 successive tests were smaller when only abnormal 
      points were included. Analyzing only abnormal grid points yields an outcome 
      parameter with a greater deviation from normal, a more homogenous dataset, and 
      better test-retest variability, compared with analysis of all grid points. This 
      parameter may thus be more sensitive to change, while moderately limiting the 
      number of potential recruits. The proposed outcome measures should be further 
      investigated as potential endpoints in clinical trials in iAMD.
FAU - Barkana, Yaniv
AU  - Barkana Y
AD  - Galimedix Therapeutics, 3704 Calvend Lane, Kensington, MD, 20895, USA. 
      yanivbarkana@gmail.com.
AD  - The Glaucoma Innovation & Research Lab, The Sam Rothberg Glaucoma Center, Sheba 
      Medical Center, Ramat Gan, Israel. yanivbarkana@gmail.com.
FAU - Pondorfer, Susanne G
AU  - Pondorfer SG
AD  - Department of Ophthalmology, University of Bonn, Bonn, Germany.
FAU - Schmitz-Valckenberg, Steffen
AU  - Schmitz-Valckenberg S
AD  - John A. Moran Eye Center, University of Utah, Salt Lake City, UT, USA.
FAU - Russ, Hermann
AU  - Russ H
AD  - Galimedix Therapeutics, 3704 Calvend Lane, Kensington, MD, 20895, USA.
FAU - Finger, Robert P
AU  - Finger RP
AD  - Department of Ophthalmology, University of Bonn, Bonn, Germany.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20210226
PL  - England
TA  - Sci Rep
JT  - Scientific reports
JID - 101563288
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Clinical Trials as Topic
MH  - Cross-Sectional Studies
MH  - Diagnostic Techniques, Ophthalmological
MH  - Female
MH  - Humans
MH  - Macula Lutea/pathology
MH  - Macular Degeneration/*diagnosis
MH  - Male
MH  - Middle Aged
MH  - Retrospective Studies
MH  - Visual Acuity
PMC - PMC7910434
COIS- Y.B., S.G.P, and H.R. declare no competing interests. S.S.V reports grants from 
      Acucela/Kubota Vision, grants and personal fees from Allergan, personal fees from 
      Bayer, non-financial support from Carl Zeiss MediTec, non-financial support from 
      Centervue, personal fees from Gailmedix, personal fees and non-financial support 
      from Heidelberg Engineering, grants from Katario, grants and personal fees from 
      Novartis, grants and personal fees from Roche, personal fees from Oxurion, grants 
      and personal fees from Bioeq/Formycon, personal fees from Apellis, grants from 
      SparingVision, grants from Pixium, outside the submitted work. R.P.F. reports 
      grants from Biogen. R.P.F. reports grants from Biogen, grants and personal fees 
      from Novartis, personal fees from Bayer, Roche, Allergan, Alimera, Opthea, 
      Inositec, Santhera, Ellex, non-financial support from Carl Zeiss MediTec, 
      Centervue, Heidelberg Engineering, outside the submitted work.
EDAT- 2021/02/28 06:00
MHDA- 2021/12/16 06:00
PMCR- 2021/02/26
CRDT- 2021/02/27 05:38
PHST- 2020/10/31 00:00 [received]
PHST- 2021/02/08 00:00 [accepted]
PHST- 2021/02/27 05:38 [entrez]
PHST- 2021/02/28 06:00 [pubmed]
PHST- 2021/12/16 06:00 [medline]
PHST- 2021/02/26 00:00 [pmc-release]
AID - 10.1038/s41598-021-83716-w [pii]
AID - 83716 [pii]
AID - 10.1038/s41598-021-83716-w [doi]
PST - epublish
SO  - Sci Rep. 2021 Feb 26;11(1):4764. doi: 10.1038/s41598-021-83716-w.