Comparative Study Between Non-Diffractive Extended Depth of Focus and Monofocal Intraocular Lenses

Figures & data

Table 1 Preoperative and Patient Demographics

Baseline Factor	ZCBOO/ZCTx Mean ± SD (Range)	DATx15 Mean ± SD (Range)	P-value
Eyes (Participants)	60 (30)	64 (32)	–
Toric, n (%)	7 (11.7)	29 (45.3)
Non-Toric, n (%)	53 (88.3)	35 (54.7)
Age (Years)	71.9 ± 7.9 (51 to 86)	72.4 ± 6.5 (59 to 90)	0.82
Sex			0.32
Female (%)	60	47
Male (%)	40	53
Axial Length (mm)	23.9 ± 1.3 (22.0 to 27.5)	23.8 ± 1.2 (21.9 to 27.0)	0.96
Anterior Chamber Depth (mm)	3.24 ± 0.42 (2.58 to 4.25)	3.11 ± 0.36 (2.35 to 3.94)	0.18
Keratometry (D)	44.1 ± 1.7 (41.5 to 47.0)	44.1 ± 1.4 (40.5 to 47.4)	0.87
Manifest Refraction Spherical Equivalent (D)	−0.06 ± 2.79 (−11.1 to 4.00)	−0.25 ± 2.92 (−7.69 to 3.75)	0.97
Interpupillary Distance (mm)	61.4 ± 3.4 (55.0 to 68.0)	62.2 ± 3.5 (56.0 to 70.0)	0.47
Intraocular Lens Power (D)	20.42 ± 3.4 (10.25 to 25.0)	20.17 ± 3.0 (11.5 to 24.0)	0.75

Abbreviations: D, diopters; SD, standard deviation.

Table 2 Summary of Monocular Visual Acuity

Monocular Visual Acuity	ZCBOO/ZCTx Mean ± SD (Range) logMAR	DATx15 Mean ± SD (Range) logMAR	P-value
UDVA (6m)	0.08 ± 0.11 (−0.18 to 0.50)	0.10 ± 0.10 (−0.10 to 0.44)	0.14
CDVA (6m)	−0.03 ± 0.09 (−0.26 to 0.14)	0.02 ± 0.07 (−0.14 to 0.22)	0.007
UIVA (66cm)	0.24 ± 0.15 (0.00 to 0.60)	0.15 ± 0.10 (0.00 to 0.48)	<0.001
DCIVA (66cm)	0.25 ± 0.10 (0.00 to 0.54)	0.18 ± 0.12 (−0.02 to 0.52)	<0.001
UNVA (40m)	0.59 ± 0.17 (0.30 to 1.00)	0.36 ± 0.14 (0.10 to 0.70)	<0.001
DCNVA (40cm)	0.56 ± 0.13 (0.32 to 0.90)	0.41 ± 0.14 (0.20 to 0.80)	<0.001

Abbreviations: CDVA, corrected distance visual acuity; DCIVA, distance-corrected intermediate visual acuity; DCNVA, distance-corrected near visual acuity; SD, standard deviation; UDVA, uncorrected distance visual acuity; UIVA, uncorrected intermediate visual acuity; UNVA, uncorrected near visual acuity.

Table 3 Summary of Binocular Visual Acuity

Binocular Visual Acuity	ZCBOO/ZCTx Mean ± SD (Range) logMAR	DATx15 Mean ± SD (Range) logMAR	P-value
UDVA (6m)	0.03 ± 0.06 (−0.08 to 0.20)	0.06 ± 0.07 (−0.06 to 0.22)	0.071
CDVA (6m)	−0.04 ± 0.08 (−0.22 to 0.12)	0.00 ± 0.05 (−0.16 to 0.12	0.034
UIVA (66cm)	0.22 ± 0.21 (0.00 to 1.00)	0.11 ± 0.10 (−0.06 to 0.36)	0.020
DCIVA (66cm)	0.20 ± 0.09 (0.00 to 0.34)	0.12 ± 0.11 (−0.08 to 0.40)	<0.001
UNVA (40m)	0.53 ± 0.15 (0.30 to 0.90)	0.32 ± 0.13 (0.10 to 0.56)	<0.001
DCNVA (40cm)	0.52 ± 0.11 (0.32 to 0.80)	0.36 ± 0.12 (0.12 to 0.58)	<0.001

Abbreviations: CDVA, corrected distance visual acuity; DCIVA, distance-corrected intermediate visual acuity; DCNVA, distance-corrected near visual acuity; SD, standard deviation; UDVA, uncorrected distance visual acuity; UIVA, uncorrected intermediate visual acuity; UNVA, uncorrected near visual acuity.

Figure 1 Binocular defocus curve for ZCBOO/ZCTx group (red) and DATx15 group (blue). Error bars represent mean ± standard deviation.

Table 4 Summary of IOLSAT Questionnaire Responses

Condition		Percentage of Subjects Never or Rarely Needing Glasses		P-value
		ZCBOO/ZCTx	DATx15
Overall		43.3	74.2	0.035
General	Distance (“far away”)	93.3	90.3	0.36
	Intermediate (“arm’s length”)	80.0	93.5	0.08
	Near (“up close”)	13.4	58.1	0.004
Bright Light	Distance (“far away”)	93.4	93.6	0.61
	Intermediate (“arm’s length”)	86.7	87.1	0.27
	Near (“up close”)	23.4	71.0	0.005
Dim Light	Distance (“far away”)	90.0	87.1	0.50
	Intermediate (“arm’s length”)	73.3	90.4	0.12
	Near (“up close”)	20.0	58.1	0.004

Notes: Note that p-value is based on a one-sided 2-sample test for equality of proportions.

Table 5 Summary of QUVID Questionnaire Responses

Disturbance	Percentage of Subjects Reported Experiencing Visual Disturbance
	ZCBOO/ZCT Without Correction	ZCBOO/ZCT with Correction	DATx15 Without Correction	DATx15 with Correction
Starbursts (Nighttime)	20.7	3.4	28.1	3.1
Halos (Nighttime)	27.6	0	25.0	0
Glare (Daytime)	62.1	3.4	54.8	0
Blur (Daytime)	14.3	3.6	19.4	0
Negative Dysphotopsias	6.9	0	12.5	0

Table 6 Biometric Correlations

	Mean ± SD (Range)	Comparison Variable	P-value	R-Value
Preoperative Average Binocular ACD (mm)	3.11± 0.36 (2.35 to 3.94)	Binocular DCNVA	0.0319	−0.38
Preoperative ACD (mm)	3.11± 0.37 (1.98 to 4.04)	Monocular UNVA	0.0231	−0.28
Intraocular Lens Power (D)	20.17 ± 2.94 (11.5 to 24)	Monocular UNVA	0.0049	0.35
Interpupillary Distance (mm)	62.19 ± 3.49 (56 to 70)	Monocular DCNVA	0.0053	0.34

Abbreviations: ACD, anterior chamber depth; DCNVA, distance corrected near visual acuity; UNVA, uncorrected near visual acuity.