Study Design and Ethics

This was a prospective nonrandomized, noncontrolled follow-up study of 137 patients. The ethical board of Tampere University Hospital, Tampere, Finland, approved the protocol (ETL R14087). Prior to providing consent to participate in the study, each patient was informed about the purpose, methods, and possible complications of the study, including the fact that, for some patients, MIOLs are associated with aberrant light perception disturbances. The study was conducted according to Good Clinical Practice, and the study protocol adhered to the tenets of the Declaration of Helsinki.

The primary outcome was measured as the change in response to the generic HRQoL 15D questionnaire after CLE and MIOL implantation and during the 1-year follow-up. Secondary outcomes were measured as changes in response to the VRQoL VF-14 questionnaire and visual acuity. Patients were recruited from the clinics of Medilaser Coronaria (Oulu, Finland) where the surgeries were performed.

Inclusion and Exclusion Criteria

Inclusion criteria were limited to patients with distance-corrected near visual acuity <0.5 Snellen at 40 cm using the standardized 40-cm reading chart, ages 40-75 years, eligible for bilateral surgery, and corrected distance visual acuity ≥0.8 Snellen in both eyes to exclude significant cataract. Exclusion criteria were age <40 or >75 years, unilateral surgery, corrected distance visual acuity <0.8 Snellen in either eye, clinically significant signs of or pre-existing glaucoma, age-related macular degeneration, amblyopia, cornea dystrophy or opacity, phacodonesis, or previous refractive surgery.

Clinical Evaluation

Preoperative examination included refraction, slit lamp evaluation, and funduscopy. The following clinical indexes were evaluated: monocular uncorrected distance visual acuity, binocular uncorrected distance visual acuity, binocular uncorrected near and intermediate visual acuity (UNVA 40 cm, UIVA 63 cm, UIVA 100 cm) using the Early Treatment of Diabetic Retinopathy Study (ETDRS) charts with the 40-cm/63-cm/100-cm ruler string, intraocular pressure (Icare tonometer; Revenio, Vantaa, Finland), and biometry (IolMaster 500; Carl Zeiss, Jena, Germany). Toric lenses were selected when applicable.

Generic HRQoL

The generic HRQoL was assessed by the HRQoL 15D questionnaire ( www.15d-instrument.net ) that evaluates 15 dimensions: mobility, vision, hearing, breathing, sleeping, eating, speech (communication), excretion, usual activities, mental function, discomfort and symptoms, depression, distress, vitality, and sexual activity. For each dimension, the study subject chooses one of the 5 levels that best describe his or her state of health at present time. The valuation system uses multiattribute utility theory, and the dimension levels are calculated from a health state descriptive system by using a population-based preference. The single index score (HRQoL 15D score) varies on a 0-1 scale (1 = full health). The HRQoL 15D scores were obtained prior to CLE and MIOL implantation and at 6 months and 1 year after surgery. A change of 0.015 is considered to be clinically meaningful.

VRQoL

VRQoL was measured with the self-assessed VF-14. VF-14 scores were obtained prior to CLE and MIOL implantation and at 6 months and 1 year after surgery.

Need of Spectacles

The need for spectacles after surgery was evaluated with our 6-scale Likert-type questions (6 = always, 5 = most of the time, 4 = half of the time, 3 = less than half of the time, 2 = sometimes, 1 = never).

Intraocular Lenses

Surgeons selected MIOLs that were implanted with their own and their patients’ preferences. MIOLs were implanted into the lens bag after phacoemulsification. The MIOLs were Tecnis +3.25 bifocal (Johnson & Johnson, Santa Ana, CA), Tecnis Symfony extended depth of focus IOL (Johnson & Johnson), PanOptix trifocal (Alcon, Fort Worth, TX), FineVision trifocal (PhysIOL, Liège, Belgium), and AT LISA tri trifocal (Carl Zeiss).

Statistical Analysis

Data were calculated as means ± standard deviations. The HRQoL 15D and VF-14 data were analyzed as previously described. ^, Repeated measures analysis of variance was used to assess factors affecting HRQoL 15D scores. Associations were tested with Spearman nonparametric correlations. Statistical analysis was done with SPSS for Windows software (version 26.0; IBM Corp, Chicago, IL). P values <.05 were considered to be statistically significant.

Characteristics of the Study Subjects

The age of the study population was 57 ± 6 years and 58% were women. All patients completed the 6-month follow-up, and 134 completed the 1-year follow-up. The near add was 2.1 ± 0.3 diopters (D). Visual acuity and refraction changes are presented in Table 1 . Nd:YAG laser capsulotomy (LCT) was performed on 5.5% of the eyes, and laser refractive enhancement was performed on 7% during the 1-year follow-up. There were no intraoperative complications, and no lens removals were performed during the follow-up period.

Table 1

Health-Related and Vision-Related Quality of Life After Clear Lens Extraction and Multifocal IOL Implantation

Parameter	Preop. (n = 137)	Postop. 6 mo (n = 137)	Postop. 12 mo (n = 134)
UDVA (logMAR)
Right eye	0.57±0.52	0.04±0.10 *	0.03±0.09 *
Left eye	0.55±0.51	0.04±0.11 *	0.04±0.10 *
Binocular UNVA (40-cm) (logMAR)	0.59±0.15	0.07±0.09 *	0.08±0.09 *
Binocular UIVA (63-cm) (logMAR)		0.06±0.11	0.05±0.10
Binocular UIVA (100-cm) (logMAR)		0.09±0.13	0.07±0.12
Refraction sphere (D)
Right eye	0.79±2.46	0.18±0.39 *	0.19±0.38 *
Left eye	0.72±2.65	0.23±0.37 *	0.23±0.33 *
Refraction cylinder (D)
Right eye	–0.66±0.47	–0.49±0.31 *	–0.49±0.28 *
Left eye	–0.62±0.42	–0.50±0.28 *	–0.50±0.27 *

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