June 2022
Volume 63, Issue 7
Open Access
ARVO Annual Meeting Abstract  |   June 2022
Cone contrast testing as an early functional biomarker of age-related macular degeneration
Author Affiliations & Notes
  • Vaishali H Oza
    Tulane University School of Medicine, New Orleans, Louisiana, United States
  • Leonie Kurzlechner
    Department of Ophthalmology, Duke University Medical Center, Durham, North Carolina, United States
  • Cheryl Nordstrom
    Innova Systems, Inc., Burr Ridge, Illinois, United States
  • Ulrich F O Luhmann
    F Hoffmann-La Roche AG Research and Development Division, Basel, Basel-Stadt, Switzerland
  • Sandra Stinnett
    Department of Ophthalmology, Duke University Medical Center, Durham, North Carolina, United States
  • Eleonora M Lad
    Department of Ophthalmology, Duke University Medical Center, Durham, North Carolina, United States
  • Footnotes
    Commercial Relationships   Vaishali Oza None; Leonie Kurzlechner None; Cheryl Nordstrom Innova Systems, Inc., Code E (Employment); Ulrich Luhmann F. Hoffmann – La Roche Ltd. (Basel, Switzerland), Code E (Employment); Sandra Stinnett None; Eleonora Lad Novartis, F. Hoffman – La Roche, Apellis, Annexon Biosciences, Allegro Ophthalmics, Gemini Therapeutics, Galimedix, Retrotope, Alexion Pharmaceuticals, Iveric Bio, Laboratoires Thea, Code C (Consultant/Contractor), F. Hoffman La Roche Ltd. (Basel, Switzerland), Apellis, Novartis, Boehringer Ingelheim, LumiThera, Gemini Therapeutics, Code F (Financial Support)
  • Footnotes
    Support  Supported by the National Eye Institute, National Institutes of Health, Bethesda, Maryland (grant no.: K23EY026988- EMLad); F. Hoffmann – La Roche Ltd., Basel, Switzerland (EML through Duke University). The sponsor F. Hoffmann – La Roche Ltd. participated in the design of the study, data analysis, interpretation of the data, review and approval of the abstract.
Investigative Ophthalmology & Visual Science June 2022, Vol.63, 317 – F0148. doi:
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    • Get Citation

      Vaishali H Oza, Leonie Kurzlechner, Cheryl Nordstrom, Ulrich F O Luhmann, Sandra Stinnett, Eleonora M Lad; Cone contrast testing as an early functional biomarker of age-related macular degeneration. Invest. Ophthalmol. Vis. Sci. 2022;63(7):317 – F0148.

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

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Abstract

Purpose : Controversy exists regarding the inclusion of nonexudative age-related macular degeneration (AMD) patients in clinical studies based on structural vs. functional criteria. In a prior analysis, cone contrast testing (CCT) red distinguished intermediate AMD (iAMD) vs. controls at 12 and 24 months. Our goal was to further analyze the longitudinal changes in CCT in normal, early and iAMD participants.

Methods : As part of the single-site, prospective, observational Duke FEATURE study, 69 participants (16 healthy control, 22 early AMD, 31 iAMD) were evaluated. Study participants were assessed at baseline, 12 and 24 months using CCT red and green, dilated exam, and optical coherence tomography. CCT blue was not included in this analysis due to the potential effect of mild cataract on test performance and lack of longitudinal change over 24 months in a prior analysis.

Results : At 12 and 24 months, there was a significant difference across the three groups in the proportion of individuals with no functional deficits based on a normative database (CCT score ≥ 80), moderate deficits (score 50-80), or severe deficits (score ≤ 50) for both CCT red (baseline p=0.01; 12 and 24 months p< 0.01 Fisher’s exact test) and green (12 and 24 months p< 0.02). This significant difference between groups was only found at the baseline visit for CCT red (p=0.01) but not for CCT green (p=0.07).
Compared to normal and early AMD participants, those with iAMD were more likely to show a decrease in total CCT score (red + green) of ≥40 points from any prior visit (p< 0.05) throughout the study. Notably, of the control population, 0% had severe CCT red or green, 56% had moderate CCT red and 37% CCT green deficits at baseline. Proportions of control participants with moderate-severe CCT deficits increased over time: 6% progressed to severe and 56% to moderate deficits on CCT red at 24 months, and 6% to severe and 44% to moderate deficits on CCT green at 24 months.

Conclusions : CCT tests for red and green colors represent early functional measures of disease progression in eyes with early-iAMD. We noted a longitudinal decline in CCT function over 24 months. A subgroup of healthy control participants demonstrated functional deficits on CCT red and green, suggesting that both visual function and structural inclusion criteria should be employed in future clinical trials of nonexudative AMD.

This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.

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