June 2015
Volume 56, Issue 7
Free
ARVO Annual Meeting Abstract  |   June 2015
Impact of decentration of SDOCT volume scans on retinal thickness measurements in diabetic macula edema in a phase III multicenter randomized controlled trial (RELATION)
Author Affiliations & Notes
  • Daniel Michels
    Cologne Image Reading Center, Department of Ophthalmology, University of Cologne, Cologne, Germany
  • Tina Schick
    Cologne Image Reading Center, Department of Ophthalmology, University of Cologne, Cologne, Germany
  • Jessica Voegeler
    Novartis Pharma GmbH, Nuernberg, Germany
  • Claudia Weiss
    Novartis Pharma GmbH, Nuernberg, Germany
  • Georg Spital
    Department of Ophthalmology, St. Franziskus-Hospital, Muenster, Germany
  • Gabriele Elisabeth Lang
    University Eye Hospital, University of Ulm, Ulm, Germany
  • Sandra Liakopoulos
    Cologne Image Reading Center, Department of Ophthalmology, University of Cologne, Cologne, Germany
  • Footnotes
    Commercial Relationships Daniel Michels, Novartis Pharma GmbH (R); Tina Schick, Novartis Pharma GmbH (F); Jessica Voegeler, Novartis Pharma GmbH (E); Claudia Weiss, Novartis Pharma GmbH (E); Georg Spital, Alimera sciences (F), Alimera sciences (R), Allergan (F), Allergan (R), Bayer (F), Bayer (R), Novartis Pharma GmbH (F), Novartis Pharma GmbH (R); Gabriele Lang, Allergan (R), Bayer Vital GmbH (R), Boehringer Ingelheim (C), Boehringer Ingelheim (R), Novartis Pharma GmbH (C), Novartis Pharma GmbH (R); Sandra Liakopoulos, Allergan (R), Heidelberg Engeneering (R), Novartis Pharma GmbH (C), Novartis Pharma GmbH (R)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science June 2015, Vol.56, 1528. doi:
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      Daniel Michels, Tina Schick, Jessica Voegeler, Claudia Weiss, Georg Spital, Gabriele Elisabeth Lang, Sandra Liakopoulos, ; Impact of decentration of SDOCT volume scans on retinal thickness measurements in diabetic macula edema in a phase III multicenter randomized controlled trial (RELATION). Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):1528.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: To assess the impact of decentration of SDOCT volume scans on automated retinal thickness measurements in eyes with diabetic macula edema (DME) and the value of manual centration of the ETDRS grid by a reading center from a clinical trial perspective.

Methods: SDOCT volume scans from the RELATION study were analyzed by a reading center. In the RELATION study, patients with visual impairment due to DME were randomized to a combined group (ranibizumab plus central laser) and a laser monotherapy group. The study was terminated early due to approval of ranibizumab for DME. Following a manual correction of segmentation errors, foveal central subfield (FCS) and foveal center point (FCP) thickness values were calculated before and after manual centration of the ETDRS grid to the fovea. Retinal thickness, ETDRS visual acuity (VA) and SDOCT scan position were evaluated for their association with measurement errors by a repeated measures ANCOVA. Manual FCP thickness measurements performed by clinical sites were compared against reading center values.

Results: 275 SDOCT volume scans were available for analysis. Scan position was adequate (center of scan within 250 μm radius from FCP) in 203 cases, fair (within 500 μm) in 56 cases and poor (> 500 μm) in 16 cases. The mean absolute deviation after centration of the grid was 11.7±14.9 µm (2.9%) for FCS and 26.4±29.2 µm (8.7%) for FCP. Scan position showed an influence on the measurement error (p< 0.001 for FCS and FCP). Retinal thickness showed an influence on the error for FCS (p< 0.001) but not for FCP (p= 0.320). However, for both FCS and FCP, higher retinal thickness values appeared to be associated with a negative difference between automated and corrected values and vice versa (p< 0.001). Mean absolute difference between FCP values from clinical sites and reading center was 43.7±30.4 µm (15.6%).

Conclusions: Decentration of SDOCT volume scans may result in incorrect retinal thickness measurements in clinical trials for DME even in the absence of segmentation errors. FCP values show higher errors compared to FCS values. Manual assessment by clinical sites did not improve the measurement error. OCT scan position and retinal thickness showed an influence on the measurement error. Manual analysis of retinal thickness by a central reading center is of value in clinical trials for DME.

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