Comparison of adverse events with daily disposable hydrogels and spectacle wear: results from a 12-month prospective clinical trial☆
Section snippets
Study population
The subjects for the study were residents of Hyderabad, Andhra Pradesh, India. A total of 281 eligible subjects with no prior contact lens wear experience were enrolled in the study from August to December 1996. Subjects were randomized to either contact lens– or spectacle-wearing groups using a computer-generated random allocation table. Subjects were 16 to 35 years old; had refractive errors ranging from a −0.75-diopter (D) sphere to a −6.00 diopter (D) sphere, with a cylindrical component
Demographic data and trial profile
Two hundred eighty-one subjects were enrolled in the study, which commenced in August 1996. One hundred thirty-nine subjects were randomized to the contact lens group and 142 to the spectacle group. The study was completed in September 1997. The demographic data for the spectacle and contact lens groups are presented in Table 2.
Ninety-three of the 139 contact lens subjects (67%) and 118 of the 142 spectacle subjects (83%) completed 12 months in the study. Figure 1 depicts the trial profile
Discussion
Spectacle wear represents a benchmark from which to assess the performance of contact lens wear. Our prospective clinical trial showed that although the incidence of adverse events with daily disposable lens wear was low, the incidence was greater than that with spectacle wear. All significant adverse events were seen with daily disposable lens wear, and the majority of these were corneal infiltrative events. An earlier study conducted at the same center found that the incidence of corneal
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TFOS Lifestyle: Impact of contact lenses on the ocular surface
2023, Ocular SurfaceOcular health of children wearing daily disposable contact lenses over a 6-year period
2021, Contact Lens and Anterior EyeThe contact Lens risk survey to assess risk of soft contact lens-related inflammatory events
2021, Contact Lens and Anterior EyeCitation Excerpt :An event was considered S&S if there was potential to cause significant visual impairment and the condition warranted intervention [17,18]. This nomenclature, and the alternative, “non-serious events”, is consistent with the CLAY group’s prior work [4,5] and similar to other classification schemas seen in the literature [16–18]. The CLRS was developed and initially validated for subjects 12–33 years of age using six different multi-site fieldings (n = 1059) [3–5,7,19].
Silicone hydrogel daily disposable benefits: The evidence
2020, Contact Lens and Anterior EyeCitation Excerpt :A major benefit of single use, daily wear lenses is fewer adverse events, as compared with reusable modalities. Although infiltrative events can occur with DD contact lenses [39–41], more recent evidence supports a single use modality improving ocular health outcomes. Chalmers et al published the results of a multicentre case control study in 2012 [42]; the purpose of the study was to evaluate association between symptomatic soft contact lens related corneal infiltrative events (CIEs) with lens material, lens care products and other risk factors.
A multi-country assessment of compliance with daily disposable contact lens wear
2013, Contact Lens and Anterior EyeCitation Excerpt :Superior comfort, vision and relief from allergies have also been reported with the use of DDCLs [4–7]. While very few complications have been reported to occur with DDCL wear when compared with spectacle wear, [8] serious complications have been reported to occur with this modality [9,10]. Unfortunately, not all patients wearing DDCLs are compliant with their replacement.
Ocular physiology and comfort in neophyte subjects fitted with daily disposable silicone hydrogel contact lenses
2013, Contact Lens and Anterior EyeCitation Excerpt :In total, 23 of the 38 subjects fitted with the narafilcon A lens completed the 12 months of the study (61%). This survival rate is similar to the value of 67% reported by Sankaridurg et al. who also evaluated the performance of daily disposable contact lenses in neophytes over 1 year [18]. Santodomingo-Rubido et al. reported a better survival rate of 89% over 18 months of neophyte extended and daily wear [19] whereas Morgan et al. noted a 56% rate after 12 months of extended wear in neophytes [20].
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Supported in part by Vistakon, Johnson & Johnson, Jacksonville, Florida; Hyderabad Eye Research Foundation, India; Optometric Vision Research Foundation, Australia; and the Australian Federal Government through the Cooperative Research Centres Program.
Manuscript no. 210715.