Skip to main content

Comparison of optical coherence tomography in diabetic macular edema, with and without reading center manual grading from a clinical trials perspective.

Publication ,  Journal Article
Glassman, AR; Beck, RW; Browning, DJ; Danis, RP; Kollman, C; Diabetic Retinopathy Clinical Research Network Study Group,
Published in: Invest Ophthalmol Vis Sci
February 2009

PURPOSE: To analyze the value of reading center error correction in automated optical coherence tomography (OCT; Stratus; Carl Zeiss Meditec, Inc., Dublin, CA) retinal thickness measurements in eyes with diabetic macular edema (DME). METHODS: OCT scans (n=6522) obtained in seven Diabetic Retinopathy Clinical Research Network (DRCR.net) studies were analyzed. The reading center evaluated whether the automated center point measurement appeared correct, and when it did not, measured it manually with calipers. Center point standard deviation (SD) as a percentage of thickness, center point thickness, signal strength, and analysis confidence were evaluated for their association with an automated measurement error (manual measurement needed and exceeded 12% of automated thickness). Curves were constructed for each factor by plotting the error rate against the proportion of scans sent to the reading center. The impact of measurement error on interpretation of clinical trial results and statistical power was also assessed. RESULTS: SD was the best predictor of an automated measurement error. The other three variables did not augment the ability to predict an error using SD alone. Based on SD, an error rate of 5% or less could be achieved by sending only 33% of scans to the reading center (those with an SD >or= 5%). Correcting automated errors had no appreciable effect on the interpretation of results from a completed randomized trial and had little impact on a trial's statistical power. CONCLUSIONS: In DME clinical trials, the error involved with using automated Stratus OCT center point measurements is sufficiently small that results are not likely to be affected if scans are not routinely sent to a reading center, provided adequate quality control measures are in place.

Duke Scholars

Published In

Invest Ophthalmol Vis Sci

DOI

EISSN

1552-5783

Publication Date

February 2009

Volume

50

Issue

2

Start / End Page

560 / 566

Location

United States

Related Subject Headings

  • Tomography, Optical Coherence
  • Retina
  • Reproducibility of Results
  • Remote Consultation
  • Ophthalmology & Optometry
  • Macular Edema
  • Image Processing, Computer-Assisted
  • Humans
  • Diagnostic Errors
  • Diabetic Retinopathy
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Glassman, A. R., Beck, R. W., Browning, D. J., Danis, R. P., Kollman, C., & Diabetic Retinopathy Clinical Research Network Study Group, . (2009). Comparison of optical coherence tomography in diabetic macular edema, with and without reading center manual grading from a clinical trials perspective. Invest Ophthalmol Vis Sci, 50(2), 560–566. https://doi.org/10.1167/iovs.08-1881
Glassman, Adam R., Roy W. Beck, David J. Browning, Ronald P. Danis, Craig Kollman, and Craig Diabetic Retinopathy Clinical Research Network Study Group. “Comparison of optical coherence tomography in diabetic macular edema, with and without reading center manual grading from a clinical trials perspective.Invest Ophthalmol Vis Sci 50, no. 2 (February 2009): 560–66. https://doi.org/10.1167/iovs.08-1881.
Glassman AR, Beck RW, Browning DJ, Danis RP, Kollman C, Diabetic Retinopathy Clinical Research Network Study Group. Comparison of optical coherence tomography in diabetic macular edema, with and without reading center manual grading from a clinical trials perspective. Invest Ophthalmol Vis Sci. 2009 Feb;50(2):560–6.
Glassman, Adam R., et al. “Comparison of optical coherence tomography in diabetic macular edema, with and without reading center manual grading from a clinical trials perspective.Invest Ophthalmol Vis Sci, vol. 50, no. 2, Feb. 2009, pp. 560–66. Pubmed, doi:10.1167/iovs.08-1881.
Glassman AR, Beck RW, Browning DJ, Danis RP, Kollman C, Diabetic Retinopathy Clinical Research Network Study Group. Comparison of optical coherence tomography in diabetic macular edema, with and without reading center manual grading from a clinical trials perspective. Invest Ophthalmol Vis Sci. 2009 Feb;50(2):560–566.

Published In

Invest Ophthalmol Vis Sci

DOI

EISSN

1552-5783

Publication Date

February 2009

Volume

50

Issue

2

Start / End Page

560 / 566

Location

United States

Related Subject Headings

  • Tomography, Optical Coherence
  • Retina
  • Reproducibility of Results
  • Remote Consultation
  • Ophthalmology & Optometry
  • Macular Edema
  • Image Processing, Computer-Assisted
  • Humans
  • Diagnostic Errors
  • Diabetic Retinopathy