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Published in: Documenta Ophthalmologica 2/2015

01-04-2015 | Original Research Article

Multi-centre variability of ISCEV standard ERGs in two normal adults

Authors: R. Hamilton, A. Al Abdlseaed, J. Healey, M. M. Neveu, L. Brown, D. Keating, V. A. McBain, D. Sculfor, D. A. Thompson

Published in: Documenta Ophthalmologica | Issue 2/2015

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Abstract

Background

The reproducibility of an individual’s full-field ERG between centres has not previously been investigated.

Methods

ERGs were recorded using both silver thread and skin electrodes from the same two normal adult subjects at 15 UK centres using routine, local protocols and a highly standardised, ‘ISCEV-specified’ protocol matching the values specified in the ISCEV standard; where the ISCEV standard allows options, a single value was chosen.

Results

Inter-ocular differences were small, and amplitudes were smaller for skin than silver thread electrodes. No centre produced outlying data points, and ERGs across all 15 centres were remarkably similar. Amplitude variability was less for local protocols (using LED flashes) than for the ISCEV-specified protocol using xenon flashes (22 vs. 24 %, p = 0.01), but peak time variability was less for the ISCEV-specified protocol (6.1 vs. 7.4 %, p = 0.001). Only the DA 0.01 ERG correlated with photometric variability. The bifidity of the DA 3 a-wave doubled its peak time variability compared with the DA 10 a-wave.

Conclusions

Inter-centre amplitude variability was typically within clinically significant thresholds, suggesting that inter-centre variability with suitable standardisation may not add more to total variability than inter-subject variability. Variability improvements gained by the tighter specifications of the ISCEV-specified protocol were possibly more than lost due to imprecisions of xenon flashtubes. Peak time variability was far lower than amplitude variability, corresponding with acceptable variability of biochemical assays. These results represent a vindication of the existence of an ERG standard and suggest that further standardisation would lend itself to greater reproducibility of ERGs worldwide.
Footnotes
1
Photopic specification assumed hereafter for photometric units.
 
Literature
1.
go back to reference Marmor MF, Arden GB, Nilsson SEG et al (1989) Standard for clinical electroretinography: international standardization committee. Arch Ophthalmol 107:816CrossRef Marmor MF, Arden GB, Nilsson SEG et al (1989) Standard for clinical electroretinography: international standardization committee. Arch Ophthalmol 107:816CrossRef
3.
go back to reference Hund E, Massart DL, Smeyers-Verbeke J (2000) Inter-laboratory studies in analytical chemistry. Anal Chim Acta 423:145–165CrossRef Hund E, Massart DL, Smeyers-Verbeke J (2000) Inter-laboratory studies in analytical chemistry. Anal Chim Acta 423:145–165CrossRef
4.
go back to reference International Standardization Organisation (1994) ISO 5725:1994(en) Accuracy (trueness and precision) of measurement methods and results. Switzerland, Geneva International Standardization Organisation (1994) ISO 5725:1994(en) Accuracy (trueness and precision) of measurement methods and results. Switzerland, Geneva
7.
go back to reference Aunon JI, Cantor FK (1977) VEP and AEP variability: interlaboratory vs. intralaboratory and intersession vs. intrasession variability. Electroencephalogr Clin Neurophysiol 42:705–708CrossRefPubMed Aunon JI, Cantor FK (1977) VEP and AEP variability: interlaboratory vs. intralaboratory and intersession vs. intrasession variability. Electroencephalogr Clin Neurophysiol 42:705–708CrossRefPubMed
11.
go back to reference Bland JM, Altman DG (1996) Statistics notes: measurement error proportional to the mean. Br Med J 313:106CrossRef Bland JM, Altman DG (1996) Statistics notes: measurement error proportional to the mean. Br Med J 313:106CrossRef
13.
go back to reference Healey J, Al Abdlseaed A, Nevea M et al (2012) Variability of amplifier characteristics across 15 UK clinics. ISCEV 50th Symposium, Valencia, Spain. Doc Ophthalmol 121(1S):37 Healey J, Al Abdlseaed A, Nevea M et al (2012) Variability of amplifier characteristics across 15 UK clinics. ISCEV 50th Symposium, Valencia, Spain. Doc Ophthalmol 121(1S):37
14.
15.
go back to reference Birch D, Anderson J (1992) Standardized full-field electroretinography—normal values and their variation with age. Arch Ophthalmol 110:1571–1576CrossRefPubMed Birch D, Anderson J (1992) Standardized full-field electroretinography—normal values and their variation with age. Arch Ophthalmol 110:1571–1576CrossRefPubMed
16.
go back to reference Jacobi PC, Miliczek K-D, Zrenner E (1993) Experiences with the international standard for clinical electroretinography: normative values for clinical practice, interindividual and intraindividual variations and possible extensions. Doc Ophthalmol 85:95–114. doi:10.1007/BF01371126 CrossRefPubMed Jacobi PC, Miliczek K-D, Zrenner E (1993) Experiences with the international standard for clinical electroretinography: normative values for clinical practice, interindividual and intraindividual variations and possible extensions. Doc Ophthalmol 85:95–114. doi:10.​1007/​BF01371126 CrossRefPubMed
17.
go back to reference Chambers W (2005) Regulatory perspectives. Special session on drug development & clinical trials ISCEV XLIII Symposium, Glasgow, UK. ISCEV, ISBN 0-9527391-2-7:89 Chambers W (2005) Regulatory perspectives. Special session on drug development & clinical trials ISCEV XLIII Symposium, Glasgow, UK. ISCEV, ISBN 0-9527391-2-7:89
20.
go back to reference Fishman GA, Chappelow AV, Anderson RJ, et al. (2005) Short-term inter-visit variability of erg amplitudes in normal subjects and patients with retinitis pigmentosa. Retina (Philadelphia, Pa) 25:1014–1021 Fishman GA, Chappelow AV, Anderson RJ, et al. (2005) Short-term inter-visit variability of erg amplitudes in normal subjects and patients with retinitis pigmentosa. Retina (Philadelphia, Pa) 25:1014–1021
21.
go back to reference Hill P, Uldall A, Wilding P (1996) Fundamentals for external quality assessment (EQA). Guidelines on improving analytical quality by establishing and managing EQA schemes. Examples from basic clinical chemistry using limited resources. IFCC, Milano, Italy Hill P, Uldall A, Wilding P (1996) Fundamentals for external quality assessment (EQA). Guidelines on improving analytical quality by establishing and managing EQA schemes. Examples from basic clinical chemistry using limited resources. IFCC, Milano, Italy
23.
go back to reference Esakowitz L, Kriss A, Shawkat F (1993) A comparison of flash electroretinograms recorded from Burian Allen, Jet, C-Glide, Gold Foil, Dtl and skin electrodes. Eye 7:169–171CrossRefPubMed Esakowitz L, Kriss A, Shawkat F (1993) A comparison of flash electroretinograms recorded from Burian Allen, Jet, C-Glide, Gold Foil, Dtl and skin electrodes. Eye 7:169–171CrossRefPubMed
24.
go back to reference Mortlock KE, Binns AM, Aldebasi YH, North RV (2010) Inter-subject, inter-ocular and inter-session repeatability of the photopic negative response of the electroretinogram recorded using DTL and skin electrodes. Doc Ophthalmol 121:123–134. doi:10.1007/s10633-010-9239-9 CrossRefPubMed Mortlock KE, Binns AM, Aldebasi YH, North RV (2010) Inter-subject, inter-ocular and inter-session repeatability of the photopic negative response of the electroretinogram recorded using DTL and skin electrodes. Doc Ophthalmol 121:123–134. doi:10.​1007/​s10633-010-9239-9 CrossRefPubMed
25.
26.
go back to reference Hogg C, Shaheen S, Hamburg S et al (2014) Comparison of dark-adapted ERGs to standard and bright flashes in controls and patients. ISCEV 51st Symposium, Chongqing, China. Doc Ophthalmol 127(1S):12 Hogg C, Shaheen S, Hamburg S et al (2014) Comparison of dark-adapted ERGs to standard and bright flashes in controls and patients. ISCEV 51st Symposium, Chongqing, China. Doc Ophthalmol 127(1S):12
27.
go back to reference Feinberg M (1995) Basics of interlaboratory studies: the trends in the new ISO 5725 standard edition. TrAC Trend Anal Chem 14:450–457 Feinberg M (1995) Basics of interlaboratory studies: the trends in the new ISO 5725 standard edition. TrAC Trend Anal Chem 14:450–457
Metadata
Title
Multi-centre variability of ISCEV standard ERGs in two normal adults
Authors
R. Hamilton
A. Al Abdlseaed
J. Healey
M. M. Neveu
L. Brown
D. Keating
V. A. McBain
D. Sculfor
D. A. Thompson
Publication date
01-04-2015
Publisher
Springer Berlin Heidelberg
Published in
Documenta Ophthalmologica / Issue 2/2015
Print ISSN: 0012-4486
Electronic ISSN: 1573-2622
DOI
https://doi.org/10.1007/s10633-014-9471-9

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