Clinical ophthalmology (Auckland, N.Z.) · 2025
A 12-Month Multicenter Postmarketing Clinical Study of a Trifocal Intraocular Lens in a Chinese Population.
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Liu Xin, Bao Yongzhen, Lu Yi, Fan Wei, Bi Hongsheng, Zhang Hong, Chen Weirong, Liu Jiewei, Song Xudong, Pang Yilin, Yao Ke
Аннотация
PURPOSE: This 12-month, prospective, single-arm, postmarketing study assessed efficacy, safety, and patient satisfaction for AcrySof IQ PanOptix TFNT00 intraocular lens in a Chinese population.
PATIENTS AND METHODS: Adults with bilateral cataracts received TFNT00 (286 eyes); visual acuity (VA) was assessed at 12 months. Manifest refraction spherical equivalent (MRSE), corrected and uncorrected distance VA (CDVA, UDVA), distance-corrected and uncorrected intermediate (DCIVA, UIVA) and near (DCNVA, UNVA) VA, and defocus curve were evaluated. Patient-reported outcomes were assessed using questionnaires. Adverse events (AEs) were evaluated.
RESULTS: 134/144 patients (268/286 eyes) completed the study. At 12 months, MRSE was -0.06±0.36 D. Monocular and binocular CDVA ≤0.3 logMAR was achieved in 99.3% of patients. Mean±SD monocular CDVA, UDVA, DCIVA, UIVA, DCNVA, and UNVA were -0.01±0.13, 0.04±0.13, 0.076±0.14, 0.089±0.14, 0.084±0.13, and 0.096±0.13 logMAR, respectively. Binocular VA was equal to or better than 0.1 logMAR for defocus range +0.5 to -3.0 D. Most patients achieved spectacle independence for distance (94%), intermediate (90%), and near (87%) vision; 88% were "satisfied" or "very satisfied." No device-related AEs were reported. Forty eyes (14%) had posterior capsular opacity (37 were clinically nonsignificant; 1 [0.4%] required posterior capsulotomy). Five cystoid macular edema cases (1.7%) were reported. Severe starbursts, halo, and glare were reported by 15.6%, 4.4%, and 2.3% of patients, respectively, with only 1.5% of patients significantly bothered by each.
CONCLUSION: TFNT00 was safe and effective in a Chinese population, providing good VA at far, intermediate, and near distances, with high rates of spectacle independence and patient satisfaction.
PATIENTS AND METHODS: Adults with bilateral cataracts received TFNT00 (286 eyes); visual acuity (VA) was assessed at 12 months. Manifest refraction spherical equivalent (MRSE), corrected and uncorrected distance VA (CDVA, UDVA), distance-corrected and uncorrected intermediate (DCIVA, UIVA) and near (DCNVA, UNVA) VA, and defocus curve were evaluated. Patient-reported outcomes were assessed using questionnaires. Adverse events (AEs) were evaluated.
RESULTS: 134/144 patients (268/286 eyes) completed the study. At 12 months, MRSE was -0.06±0.36 D. Monocular and binocular CDVA ≤0.3 logMAR was achieved in 99.3% of patients. Mean±SD monocular CDVA, UDVA, DCIVA, UIVA, DCNVA, and UNVA were -0.01±0.13, 0.04±0.13, 0.076±0.14, 0.089±0.14, 0.084±0.13, and 0.096±0.13 logMAR, respectively. Binocular VA was equal to or better than 0.1 logMAR for defocus range +0.5 to -3.0 D. Most patients achieved spectacle independence for distance (94%), intermediate (90%), and near (87%) vision; 88% were "satisfied" or "very satisfied." No device-related AEs were reported. Forty eyes (14%) had posterior capsular opacity (37 were clinically nonsignificant; 1 [0.4%] required posterior capsulotomy). Five cystoid macular edema cases (1.7%) were reported. Severe starbursts, halo, and glare were reported by 15.6%, 4.4%, and 2.3% of patients, respectively, with only 1.5% of patients significantly bothered by each.
CONCLUSION: TFNT00 was safe and effective in a Chinese population, providing good VA at far, intermediate, and near distances, with high rates of spectacle independence and patient satisfaction.