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Cynthia A. Toth, Francis C. DeCroos, Glenn J. Jaffe, Gui-Shuang Ying, Sandra S. Stinnett, Cynthia S. Heydary, Russell Burns, CATT Research Group; Comparison of RC and Investigator Determined Retinal and Subretinal fluid in the Comparison of Age-Related Macular Degeneration Treatment Trials (CATT). Invest. Ophthalmol. Vis. Sci. 2012;53(14):2894.
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Compare investigator treatment decisions with OCT Reading Center (RC) identification of intraretinal fluid (IRF), subretinal fluid (SRF), and sub-retinal pigment epithelium (sub-RPE) fluid from analysis of year-one CATT Optical Coherence Tomography (OCT) images.
OCT scans from monthly study visits of 598 patients randomized to "as-needed" treatment evaluated by RC graders masked to treatment group. When investigators observed macular IRF, SRF, and/or sub-RPE fluid on OCT, they treated per protocol unless predefined contraindications were noted. Agreement between investigator decision and RC determination for 640 I scans was classified as positive fluid agreement (PFA, +RC fluid and +treatment), negative fluid agreement (NFA, -RC fluid and -treatment), positive fluid discrepancy (PFD, +RC fluid and -treatment) and negative fluid discrepancy (NFD, -RC fluid and +treatment). Largest cross-sectional areas of fluid were compared between randomly selected PFD events (n=400) and PFA events (n=1 00). Forty-eight NFD scans were reevaluated for fluid. The proportion with treatment at subsequent visits was reviewed.
Investigator treatment and RC determination of fluid corresponded in 72.9% of decisions (54.1% PFA and 18.7% NFA) and disagreed in 25.0% PFD and 2.2% NFD. The most common PFD was for IRF alone. Median largest cross-sectional fluid area for PFA was greater than twice that of PFD for IRF, and >4 times PFD for SR and sub-RPE fluid (al1 p < 0.001). At subsequent visits, discrepancies frequently recurred (86.7%) and were not treated (54.0%). In patients, 57.9% had ≤ 3 discrepancies during year-one. For PFD- versus PFA scans, total foveal thickness was less (mean 265 ± 103 versus 371 ± 151 microns) and change in foveal thickness from baseline was greater (mean 170 ± 164 versus 114 ± 169 microns). Fluid was found on repeat evaluation in 2.1% of NFD scans.
Clinical Center Investigators treatment decisions matched RC determination of SRF in the majority of visits. PFD occurred more commonly in scans with IRF alone, thinner retinas, smaller fluid areas and greater decrease in total foveal thickness compared to scans with PFA. A more pronounced response to treatment or smaller foci of fluid may have contributed to disagreement.
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