TY - JOUR
T1 - Results of a clinical evaluation of a trifocal intraocular lens in Japan
AU - Bissen-Miyajima, Hiroko
AU - Ota, Yuka
AU - Hayashi, Ken
AU - Igarashi, Chizuka
AU - Sasaki, Noriyuki
N1 - Funding Information:
This prospective clinical trial was conducted according to the ethical principles of the Declaration of Helsinki, article 14 paragraph 3 and article 80-2 of the Pharmaceutical and Medical Device Act; the Ministerial Ordinance on Clinical Studies of Medical Devices (No. 36, Ministry of Health, Labor and Welfare; March 23, 2005); and the Notification about Enforcement of the Ministerial Ordinance on Clinical Studies of Medical Devices (No. Yakushoku-0720003, Director of Pharmaceutical and Food Safety Bureau, Ministry of Health, Labor and Welfare; July 20, 2005). The institutional review boards of each participating investigative site approved the protocol and all amendments, the informed consent form, any other written information given to subjects, and any advertisements planned for subject recruitment.
Publisher Copyright:
© 2020, Japanese Ophthalmological Society.
PY - 2020/3/1
Y1 - 2020/3/1
N2 - Purpose: To evaluate the effectiveness and safety of a new trifocal intraocular lens (IOL) after cataract removal in patients living in Japan. Study design: Prospective multicenter clinical study. Methods: One hundred and thirty-five eyes of 68 patients (19 men, 49 women; mean age, 66.3 ± 7.4 years) were followed for 6 months. Trifocal IOLs with focal points at near, intermediate, and distance were implanted bilaterally in eyes with less than 1 diopter of corneal astigmatism. The visual acuity (VA) at distance, 60 and 40 centimeters (cm), and contrast sensitivities were measured. Patients completed quality-of-life questionnaires preoperatively and postoperatively. Results: The mean bilateral logarithm of the minimum angle of resolution VA at 5 meters (m), 60 cm, and 40 cm were, respectively: uncorrected, − 0.104 ± 0.095, − 0.065 ± 0.111, and − 0.042 ± 0.105; and distance-corrected, − 0.197 ± 0.076, − 0.112 ± 0.111, and − 0.073 ± 0.111. The contrast sensitivities at distance and near were within the normal range at all spatial frequencies under photopic conditions. Patients reported complete spectacle independence in 75.0% of cases. Total use of spectacles was reported by 1.5% and partial by 20.6%; the purpose of spectacle use was primarily for near visual tasks. Mild-to-moderate glare was reported by 65.7% of patients and halos by 70.1%; only 1.5% of subjects reported severe glare and halos. Conclusions: This new trifocal IOL provides equally good uncorrected VAs at distance, intermediate, and near, and decreases spectacle dependence in daily life. Patients frequently report mild-to-moderate glare and halos, and patients should be informed about these before implantation.
AB - Purpose: To evaluate the effectiveness and safety of a new trifocal intraocular lens (IOL) after cataract removal in patients living in Japan. Study design: Prospective multicenter clinical study. Methods: One hundred and thirty-five eyes of 68 patients (19 men, 49 women; mean age, 66.3 ± 7.4 years) were followed for 6 months. Trifocal IOLs with focal points at near, intermediate, and distance were implanted bilaterally in eyes with less than 1 diopter of corneal astigmatism. The visual acuity (VA) at distance, 60 and 40 centimeters (cm), and contrast sensitivities were measured. Patients completed quality-of-life questionnaires preoperatively and postoperatively. Results: The mean bilateral logarithm of the minimum angle of resolution VA at 5 meters (m), 60 cm, and 40 cm were, respectively: uncorrected, − 0.104 ± 0.095, − 0.065 ± 0.111, and − 0.042 ± 0.105; and distance-corrected, − 0.197 ± 0.076, − 0.112 ± 0.111, and − 0.073 ± 0.111. The contrast sensitivities at distance and near were within the normal range at all spatial frequencies under photopic conditions. Patients reported complete spectacle independence in 75.0% of cases. Total use of spectacles was reported by 1.5% and partial by 20.6%; the purpose of spectacle use was primarily for near visual tasks. Mild-to-moderate glare was reported by 65.7% of patients and halos by 70.1%; only 1.5% of subjects reported severe glare and halos. Conclusions: This new trifocal IOL provides equally good uncorrected VAs at distance, intermediate, and near, and decreases spectacle dependence in daily life. Patients frequently report mild-to-moderate glare and halos, and patients should be informed about these before implantation.
KW - Cataract
KW - Contrast sensitivity
KW - Spectacle use
KW - Trifocal IOL
KW - Visual acuity
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U2 - 10.1007/s10384-019-00712-4
DO - 10.1007/s10384-019-00712-4
M3 - Article
C2 - 31900871
AN - SCOPUS:85077247158
SN - 0021-5155
VL - 64
SP - 140
EP - 149
JO - Japanese Journal of Ophthalmology
JF - Japanese Journal of Ophthalmology
IS - 2
ER -