Clinical Outcomes After Bilateral Implantation of a Diffractive Trifocal Intraocular Lens: A Worldwide Pooled Analysis of Prospective Clinical Investigations

Figures & data

Table 1 Patient Baseline Characteristics and Demographics (All-Implanted Analysis Set)

Parameter	TFNT00 (N=557)
Age (years)
<65, n (%)	235 (42.2)
≥65, n (%)	322 (57.8)
Mean (SD)	65.3 (9.52)
Median (min, max)	66.0 (26, 88)
Sex, n (%)
Female	356 (63.9)
Male	201 (36.1)
Race, n (%)
White	294 (52.8)
Asian	197 (35.4)
Black or African American	10 (1.8)
Native Hawaiian or other Pacific Islander	2 (0.4)
Other	54 (9.7)

Abbreviation: SD, standard deviation.

Figure 1 Ethnicity by study and geographical region. Data are from the following studies for (A) Modi S et al,¹⁴ (B) Kohnen T et al,¹³ (C) Lapid-Gortzak R et al,⁷ (D) Ramamurthy D et al,¹⁷ (E) Kim TI et al,¹⁶ (F) Bissen-Miyajima H et al.¹⁵

Abbreviations: UK, United Kingdom; US, United States.

Figure 2 Mean binocular defocus curve at 3–6 months postoperatively (logMAR).

Notes: Chart represents mean values in logMAR (left y-axis) and Snellen equivalent (right y-axis) ± 95% CIs.

Abbreviations: CI, confidence interval; D, diopter; logMAR, logarithm of the minimum angle of resolution; VA, visual acuity.

Figure 3 Mean corrected distance, intermediate, and near VA (A) at 3–6 months and (B) at 1 month postoperatively and mean uncorrected distance, intermediate, and near VA (C) at 3–6 months and (D) at 1 month postoperatively (logMAR).

Notes: Charts represent mean values in logMAR (left y-axis) and Snellen equivalent (right y-axis) ± SD.

Abbreviations: BCDVA, best-corrected distance visual acuity; DCIVA, distance-corrected intermediate visual acuity; DCNVA, distance-corrected near visual acuity; logMAR, logarithm of the minimum angle of resolution; SD, standard deviation; UCDVA, uncorrected distance visual acuity; UCIVA, uncorrected intermediate visual acuity; UCNVA, uncorrected near visual acuity; VA, visual acuity.

Figure 4 Categorical statistics for photopic binocular (A) distance-corrected and (B) uncorrected VAs at 3–6 months.

Abbreviations: BCDVA, best-corrected distance visual acuity; DCIVA, distance-corrected intermediate visual acuity; DCNVA, distance-corrected near visual acuity; logMAR, logarithm of the minimum angle of resolution; UCDVA, uncorrected distance visual acuity; UCIVA, uncorrected intermediate visual acuity; UCNVA, uncorrected near visual acuity; VA, visual acuity.

Table 2 Summary of Ocular Adverse Device Effects Associated with the IOL (Safety Analysis Set)

	First Eye (n=557)			Second Eye (n=547)
Preferred Term	n (%)	2-Sided 95% CI	E	n (%)	2-Sided 95% CI	E
Halo vision	12 (2.2)	(1.12, 3.73)	12	11 (2.0)	(1.01, 3.57)	11
Glare	6 (1.1)	(0.40, 2.33)	6	5 (0.9)	(0.30, 2.12)	5
Posterior capsule opacification	3 (0.5)	(0.11, 1.57)	3	5 (0.9)	(0.30, 2.12)	5
Visual impairment	3 (0.5)	(0.11, 1.57)	3	2 (0.4)	(0.04, 1.31)	2
Vision blurred	2 (0.4)	(0.04, 1.29)	2	0 (0.0)	(0.00, 0.67)	0
Lens extraction^a	2 (0.4)	(0.04, 1.29)	2	0 (0.0)	(0.00, 0.67)	0

Notes: ^aOccurred due to blurred vision and considered as a serious device-related adverse event¹³ or as a result of subjective reports of dissatisfaction with the level of vision, which were determined to be related to the optical properties of the IOL.¹⁴

Abbreviations: CI, confidence interval; E, events; IOL, intraocular lens.

Table 3 Summary of IOL-Associated SSIs (Safety Analysis Set)

	First Eye (n=557)		Second Eye (n=547)
	n (%)	95% CI	n (%)	95% CI
Total SSIs	2 (0.4)	(0.04, 1.31)	2 (0.4)	(0.04, 1.31)
Due to optical properties^a	2 (0.4)	(0.04, 1.31)	0 (0.0)	(0.00, 0.67)
Not due to optical properties	0 (0.0)	(0.00, 0.66)	2 (0.4)	(0.04, 1.31)

Notes: ^aThese SSIs required the lens extractions as described in Table 2.

Abbreviations: CI, confidence interval; IOL, intraocular lens; SSI, secondary surgical intervention.

Modi S, Lehmann R, Maxwell A, et al. Visual and patient-reported outcomes of a diffractive trifocal intraocular lens compared with those of a monofocal intraocular lens. Ophthalmology. 2021;128(2):197–207. doi:10.1016/j.ophtha.2020.07.015

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