Bifocal and Multifocal Contact Lenses for Presbyopia and Myopia Control

Table 6

Outcomes from clinical trials involving the use of bifocal/dual-focus and multifocal (including peripheral gradient and extended depth of focus) contact lenses for myopia control.

Author (year)	Lens design (trial duration, moths)	N	Axial growth (%)	Binocular distance visual acuity	Binocular near visual acuity HC	Accomm.	Wearing time hours/day	Discont.	Adverse events
Anstice and Phillips (2011) [42]	DF (10 months)	T: 52; C: 56	0.10 mm; 0.22 mm (−55%)	99.9 ± 3.5; 100 ± 2.9		No change	13.2 ± 2.8; 11.9 ± 2.0	N.R	N.R
Allen et al. (2013) [120]	−SA (24)	T: 29; C: 30	0.15; 0.16 (−6%)	N.R	N.R	Improves Acc flexibility	N.R	12/41; 15/45	N.R
Walline et al. (2013) [2]	CDMF (24)	T: 27; C: 27	0.29; 0.41 (−29%)	N.R	N.R	N.R	N.R	5/32; 5/32	N.R
Lam et al. (2014) [125]	DISC (24)	T: 65; C: 63	0.25; 0.36 (−31%)	N.R	N.R	N.R	6.5 ± 2.2; 6.3 ± 1.7	46/111; 47/110	N.R
Cheng et al. (2016) [126]	+SA (12)	T: 53; C: 59		0.06 ± 0.06; 0.00 ± 0.08	N.R	N.R	N.R	53/64; 50/63	N.R
Aller et al. (2016) [118]	CDBF (12)	T: 39; C: 40	0.05; 0.24 (−79%)	N.R	N.R	N.R	N.R		N.R
Pauné et al. (2016) [11]	PG (24)	T: 19; C: 21	0.38; 0.52 (−27%)	N.R	N.R	N.R	N.R	11/30; 20/41	N.R
Ruiz-Pomeda et al. (2018) [127]	DF (24)	T: 41; C: 43	0.28; 0.45 (−38%)	N.R	N.R	N.R	12.2 ± 1.8; 11.8 ± 2.1	5/41; 0/33	N.R
Sankaridurg et al. (2019) [119]	EDOF (24)	T: 43; C: 39	0.44; 0.58 (−24%)	0.07	Visual clarity subjectively reported better than distance	N.R	N.R	28/73; 28/78	N.R
Chamberlain et al. (2019) [123]	DF (36)	T: 52; C: 56	0.30; 0.62 (−52%)	0.00 ± 0.10; N.R	−0.10 ± 0.08	N.R	13.7 ± 1.5; 13.3 ± 1.5	12/65; 14/70	No serious adverse events

Axial length growth: defined as the % of growth in the test group compared to the control group ; negative value implies a benefit of the treatment. Visual Acuity Rating Scale (100 = 6/6). DISC: defocus incorporated contact lens, concentric refractive; EDoF: extended depth of focus, only Design III is considered–currently manufactured by mark’ennovy; PG: peripheral gradient; DF: bifocal concentric design with large central zone for distance vision; CDMF: center-distance multifocal for presbyopia; CDBF: center-distance bifocal for presbyopia; +SA: soft contact lens with the induction of positive spherical aberration; −SA: soft contact lens with the induction of negative spherical aberration; T: test device: C: control device; ΔT|ΔC: increment in treatment|control groups; HC: high contrast; LC: low contrast N.R: not reported; Accomm.: accommodation; Discont.: discontinuation.