Ophthalmic research · 2025
The Specificity Rates of Clarus 500™ Ultra-Wide-Field Retinal Imaging for Detecting Peripheral Retinal Lesions in Medium-to-High Myopia Eyes.
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Xu Fangcheng, Hu Xiaojun, Wang Yunzhe, Wei Ruoyan, Yu Yongfu, Peng Yuwei, Li Meiyan, Wu Haixiang
Аннотация
INTRODUCTION: The aim of the study was to investigate the specificity of Clarus 500™, an ultra-wide-field (UWF) fundus camera, for detecting peripheral retinal lesions in myopic eyes.
METHODS: This diagnostic test included 436 eyes from 221 patients with myopia before refractive surgery. The mean age was 28.9 ± 6.0 years (18 to 49 years), with the average spherical equivalent refraction being -8.33 ± 2.81 diopters (D) (-20.63 D to -0.50 D). Images were captured using Clarus 500™ from the posterior pole and four UWF directions, including the superior temporal, superior nasal, inferior temporal, and inferior nasal gaze. A slit-lamp non-contact +120 D lens was used as the control. Sensitivity and specificity in detecting fundus lesions were compared between the images obtained by Clarus 500™ and slit-lamp examination. Statistical analysis was performed using version 4.3.0 of R software, and significance was set at p < 0.05.
RESULTS: Of the 436 eyes, 13 (2.98%) underwent slit-lamp examination, and 5 (1.15%) underwent Clarus 500™ examination, revealing retinal lesions. The sensitivity of Clarus 500™ for detecting peripheral retinal holes/tears was 50% (95% confidence interval [95% CI]: 1.26%, 98.74%). The specificity for peripheral lattice degeneration was 99.77% (95% CI: 98.70%, 99.99%). The agreement between the two methods for detecting peripheral reticular degeneration and retinal holes was moderate (kappa value: 0.42, 95% CI: 0.10-0.75, p < 0.01) and substantial (kappa value: 0.67, 95% CI: 0.05-1, p < 0.01), respectively.
CONCLUSION: Clarus 500™ showed high specificity for detecting peripheral retinal holes and substantial agreement with the slit-lamp in identifying peripheral retinal degeneration and retinal holes.
METHODS: This diagnostic test included 436 eyes from 221 patients with myopia before refractive surgery. The mean age was 28.9 ± 6.0 years (18 to 49 years), with the average spherical equivalent refraction being -8.33 ± 2.81 diopters (D) (-20.63 D to -0.50 D). Images were captured using Clarus 500™ from the posterior pole and four UWF directions, including the superior temporal, superior nasal, inferior temporal, and inferior nasal gaze. A slit-lamp non-contact +120 D lens was used as the control. Sensitivity and specificity in detecting fundus lesions were compared between the images obtained by Clarus 500™ and slit-lamp examination. Statistical analysis was performed using version 4.3.0 of R software, and significance was set at p < 0.05.
RESULTS: Of the 436 eyes, 13 (2.98%) underwent slit-lamp examination, and 5 (1.15%) underwent Clarus 500™ examination, revealing retinal lesions. The sensitivity of Clarus 500™ for detecting peripheral retinal holes/tears was 50% (95% confidence interval [95% CI]: 1.26%, 98.74%). The specificity for peripheral lattice degeneration was 99.77% (95% CI: 98.70%, 99.99%). The agreement between the two methods for detecting peripheral reticular degeneration and retinal holes was moderate (kappa value: 0.42, 95% CI: 0.10-0.75, p < 0.01) and substantial (kappa value: 0.67, 95% CI: 0.05-1, p < 0.01), respectively.
CONCLUSION: Clarus 500™ showed high specificity for detecting peripheral retinal holes and substantial agreement with the slit-lamp in identifying peripheral retinal degeneration and retinal holes.