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. 2020 Aug 26;9(9):40.
doi: 10.1167/tvst.9.9.40. eCollection 2020 Aug.

Enhancing Risk Assessment in Patients with Diabetic Retinopathy by Combining Measures of Retinal Function and Structure

Mitchell G Brigell  1 , Bryce Chiang  2   3 , April Yauguang Maa  3   4 , C Quentin Davis  5
Affiliations

Affiliations

  • 1 Aerpio Pharmaceuticals, Cincinnati, OH, USA.
  • 2 Ophthalmology, Stanford University, Palo Alto, CA, USA.
  • 3 Ophthalmology, Emory University School of Medicine, Atlanta, GA, USA.
  • 4 Regional Telehealth Services, VISN 7, Decatur, GA, USA.
  • 5 LKC Technologies Inc., Gaithersburg, MD, US.

Enhancing Risk Assessment in Patients with Diabetic Retinopathy by Combining Measures of Retinal Function and Structure

Mitchell G Brigell et al. Transl Vis Sci Technol. .
. 2020 Aug 26;9(9):40.
doi: 10.1167/tvst.9.9.40. eCollection 2020 Aug.

Authors

Mitchell G Brigell  1 , Bryce Chiang  2   3 , April Yauguang Maa  3   4 , C Quentin Davis  5

Affiliations

  • 1 Aerpio Pharmaceuticals, Cincinnati, OH, USA.
  • 2 Ophthalmology, Stanford University, Palo Alto, CA, USA.
  • 3 Ophthalmology, Emory University School of Medicine, Atlanta, GA, USA.
  • 4 Regional Telehealth Services, VISN 7, Decatur, GA, USA.
  • 5 LKC Technologies Inc., Gaithersburg, MD, US.

Abstract

Purpose: To determine whether combining measures of retinal structure and function predicts need for intervention for diabetic retinopathy (DR) better than either modality alone.

Methods: The study sample consisted of 279 diabetic patients who participated in an earlier cross-sectional study. Patients were excluded if they were previously treated for macular edema or proliferative DR or if they had other retinopathies. Medical records were reviewed for ocular interventions including vitrectomy, intravitreal injection, and laser treatment. Need for intervention was analyzed using Kaplan-Meier analyses and Cox proportional hazards. Baseline electroretinograms and fundus photographs were obtained. Two definitions of structural positive findings were as follows: 1. Early Treatment of Diabetic Retinopathy Study diabetic retinopathy severity scale (ETDRS-DR) severity ≥ level 53 (ETDRS-DR+) and 2. ETDRS-DR+ or clinically significant macular edema (VTDR+). A positive function finding corresponded to a RETeval DR Score >23.5 (RETeval+).

Results: For patients with VTDR+ the incidence of intervention was 19%, 31%, and 53% after 1, 2, and 3 years of follow-up. In these patients, intervention incidence increased to 34%, 54%, and 74% the subsequent 1, 2, and 3 years if function was above criterion (RETeval+), whereas RETeval- results reduced the risk to 3%, 4%, and 29%, respectively, reducing risk to similar levels seen for patients with VTDR- results at baseline.

Conclusions: Prediction of subsequent intervention was best when combining structural and functional information.

Translational relevance: This study demonstrates that clinical management of diabetic retinopathy is improved by adding electroretinography to fundus photographic information in assessing the risk of the need for intervention.

Keywords: diabetic retinopathy; electroretinography; fundus photography; prognosis.

PubMed Disclaimer

Conflict of interest statement

Disclosure: M.G. Brigell, None; B. Chiang, None; A.Y. Maa, None; C.Q. Davis, LKC Technologies (I, E, P)

Figures

Figure 1.

Figure 1.

(A) Percentage of patients without…

Figure 1.

(A) Percentage of patients without intervention as a function of time. Shaded area…

Figure 1.
(A) Percentage of patients without intervention as a function of time. Shaded area is the 95% confidence interval. (B) Percentage of patients without intervention as a function of RETeval DR Score (ERG/pupillography) at years 1, 2, and 3. The vertical grid line shows the cutoff point of 23.5. (C) Percentage of patients without intervention as a function of ETDRS-DR severity. The vertical grid line shows the cutoff point of ETDRS-DR severity 53 (severe NPDR). Also shown are results from the 15% of patients with ungradable photographs. The single patient with ungradable RETeval DR Score did not have an intervention and is not shown.
Figure 2.

Figure 2.

Percentage of patients without an…

Figure 2.

Percentage of patients without an ocular intervention as a function of time. The …

Figure 2.
Percentage of patients without an ocular intervention as a function of time. The red curves in each panel show patients that are positive for the criterion given in the title of each panel, whereas the green curves represent patients who were classified as negative for the criterion. The black curve is the a priori curve from Figure 1A. The P values represent the likelihood the performance difference between the two classification groups is chance. Shaded areas are the 95% CI.
Figure 3.

Figure 3.

Relative risk for binary classification…

Figure 3.

Relative risk for binary classification of patients for having an ocular intervention. Error…

Figure 3.
Relative risk for binary classification of patients for having an ocular intervention. Error bars are the 95% confidence interval. The P values represent the likelihood that the relative risk is 1.
Figure 4.

Figure 4.

The effect of the combination…

Figure 4.

The effect of the combination of structural and functional measures on the percentage…

Figure 4.
The effect of the combination of structural and functional measures on the percentage of patients without an ocular intervention as a function of time. Both panels use the functional RETeval DR Score while the structural measurement is either ETDRS-DR severity (left panel) or presence of VTDR (right panel). Positive/negative structural measurements are solid/dashed lines, respectively, whereas positive/negative functional measurements are red/green, respectively. The black curve is the a priori curve from Figure 1A.
Figure 5.

Figure 5.

The impact on probability of…

Figure 5.

The impact on probability of intervention after 1, 2, and 3 years of…

Figure 5.
The impact on probability of intervention after 1, 2, and 3 years of adding functional information to structural information (top row) or vice-versa (bottom row). For each year, the mean (± standard error of mean) of having a positive or negative measurement is shown for a first test. For positive first test results, the impact of adding a second test is shown. Stars represent statistically significant mean differences (without adjustment for multiple comparisons) for adding a second positive test, adding a second negative test, and between the second positive and negative tests. (A) The effect of RETeval result on prognosis in patients with VTDR+. (B) The effect of RETeval result on prognosis in patients with ETDRS-DR+. (C) The effect of VTDR result on prognosis in patients with RETeval+. (D) The effect of ETDRS result on prognosis in patients with RETeval+.
See this image and copyright information in PMC

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