First EDOF contact lens improves intermediate, near visual acuity in presbyopes, study finds

First FDA-cleared EDOF contact lens

A randomized crossover trial of the Deseyne contact lens for presbyopia—the first soft contact lens to receive an extended depth of focus (EDOF) designation from the FDA—found the lens extended monocular depth of focus by a mean of 0.78 D (95% CI: 0.63, 0.93) compared with a monofocal control, and significantly improved both intermediate and near visual acuity in presbyopic habitual soft contact lens wearers.¹

Contact lens dropout accelerates sharply after age 40, with vision cited as a primary driver of discontinuation.² Dropout rates among established wearers range from 12% to 27.4% across developed countries, and presbyopes represent a disproportionate share of those losses.³ A 2023 review found that presbyopia-correcting contact lenses varied widely in performance, highlighting the need for well-validated options.⁴

The prospective trial (NCT06698731) enrolled 78 presbyopic habitual soft contact lens wearers aged 45–70 years (mean 53.9 years) across three US investigational sites between October 2024 and January 2025.¹ Eligible subjects had spherical refractive errors between −6.00 and +4.00 D and less than 1.25 D of astigmatism. Subjects were fitted bilaterally with the Deseyne lens and a 1-Day Acuvue Moist (etafilcon A; Johnson & Johnson Vision) monofocal control in a crossover design, with a 30-minute washout between evaluations. The primary effectiveness endpoint followed ANSI Z80.35-2018 methodology for EDOF IOLs: monocular negative lens-induced depth of focus at a 0.2 logMAR threshold, measured by defocus curve across a vergence range of +1.50 to −3.50 D.¹

Mean monocular depth of focus was 2.22 ± 0.78 D with the Deseyne lens and 1.44 ± 0.67 D with the monofocal control, yielding a mean EDOF of 0.78 D — exceeding the prespecified noninferiority limit of 0.50 D (P = .0002).¹ The benefit was greater in subjects aged 60 years and older (mean EDOF 0.88 D) than those under 60 (0.74 D), though significant in both groups. Among subjects with the poorest residual accommodation (near visual acuity worse than 0.44 logMAR with the monofocal), mean EDOF reached 0.92 D. Subjects with pupil diameters smaller than 4.5 mm showed the greatest EDOF benefit at 1.00 D.¹

Visual performance outcomes

Mean monocular intermediate visual acuity improved by 0.14 logMAR (20/29 to 20/21; P < .0001) with the Deseyne lens compared with the monofocal control, and mean monocular near visual acuity improved by 0.16 logMAR (20/45 to 20/31; P < .0001).¹ Binocular results were stronger: mean binocular intermediate visual acuity reached −0.06 logMAR (20/18) and mean binocular near visual acuity reached +0.12 logMAR (20/26) with the Deseyne lens.¹ The improvement in intermediate visual acuity was greatest among subjects aged 60 and older (+0.22 logMAR) and those with the poorest near acuity with the control lens (+0.24 logMAR). These patterns align with findings from the broader presbyopia-correcting lens literature, where near visual acuity gains tend to be most pronounced in patients with reduced residual accommodation.⁴

Mean monocular distance visual acuity was 0.00 logMAR (20/20) with the Deseyne lens versus −0.07 logMAR (20/17) with the monofocal control, a difference of 0.07 logMAR — within the prespecified noninferiority margin of 0.10 logMAR.¹ No adverse events were reported during the study. Mesopic contrast sensitivity was significantly lower with the Deseyne lens at spatial frequencies of 3, 6, and 12 cycles per degree both with and without glare (P < .0001), a finding consistent with the tradeoffs reported with other multifocal and EDOF soft contact lenses.¹ In seven of 154 eyes (less than 5%), monocular distance visual acuity was 10 or more letters lower with the Deseyne lens than the control; in each case the reduction was transient and vision subsequently normalized. The study authors concluded the lens "extends the depth of focus of the eye and thus improves intermediate and near visual acuity" compared with single-vision distance lenses.¹

For ODs managing presbyopic patients who have discontinued or are at risk of discontinuing soft contact lens wear for visual reasons, the Deseyne lens represents a newly cleared daily disposable option within the growing EDOF category.¹ The trial was nondispensing, so spectacle independence and patient-reported satisfaction data are not yet available; those outcomes will be important in translating the clinical visual performance gains into real-world prescribing decisions.¹ A subset of early-enrolled subjects showed transient distance acuity reductions, suggesting a fitting learning curve ODs should anticipate during initial adoption.¹

References

1. Bullimore MA, Slonim CB, Montaquila SM, Catalfamo E, Montani G. A randomized crossover clinical trial of the Deseyne contact lens for presbyopia with extended depth of focus. Ophthalmic Vis Sci. 2026. https://doi.org/10.1002/ovs2.70081

2. Morgan PB, Efron N, Woods CA; International Contact Lens Prescribing Survey Consortium. An international survey of contact lens prescribing for presbyopia. Clin Exp Optom. 2011;94:87–92. https://doi.org/10.1111/j.1444-0938.2010.00524.x

3. Pucker AD, Tichenor AA. A review of contact lens dropout. Clin Optom (Auckl). 2020;12:85–94. https://doi.org/10.2147/OPTO.S198637

4. Molina-Martin A, Pinero DP, Martinez-Plaza E, Rodríguez-Vallejo M, Fernández J. Efficacy of presbyopia-correcting contact lenses: a systematic review. Eye Contact Lens. 2023;49:319–328. https://doi.org/10.1097/ICL.0000000000001013