Rates of Adverse Events With Hydrogel and Silicone Hydrogel Daily Disposable Lenses in a Large Postmarket Surveillance Registry: The TEMPO Registry

Chalmers, Robin L.; Hickson-Curran, Sheila; Keay, Lisa; Gleason, William; Albright, Roger

doi:10.1167/iovs.14-15582

Cited by 80 publications

(79 citation statements)

References 48 publications

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“…5,17,32,[34][35][36][37][38] CIE case subjects had increased exposure to soiled contact lenses; both by extending their SCL daytime wearing hours and extending the replacement of their SCLs. Our and others' work has demonstrated that planned replacement SCLs are associated with higher risk of complications than daily disposable lenses, 16,17,39,40 but little has been reported regarding the effects of longer SCL wear hours. It could be hypothesized that the longer wear hours further compromise the ocular surface and allow adherence and colonization of bacteria and thus increase the likelihood of a CIE. Other established risk factors supported by this study were use of an older contact lens storage case, 41,42 and use of multipurpose solutions (versus hydrogen peroxide), 17,39,43 and smoking.…”

Section: Discussionmentioning

confidence: 87%

Case-Control Pilot Study of Soft Contact Lens Wearers With Corneal Infiltrative Events and Healthy Controls

Richdale

Lam

Wagner

et al. 2016

Invest. Ophthalmol. Vis. Sci.

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PURPOSE. The purpose of this study was to assess risk factors associated with soft contact lens (SCL)-related corneal infiltrative events (CIEs).METHODS. This was a single-visit, case-control study conducted at five academic centers in North America. Cases were defined as current SCL wearers with a symptomatic CIE. For each case, three age-and sex-matched controls were enrolled. Subjects completed the Contact Lens Risk Survey (CLRS), a standardized scripted medical interview, supplied a recent health history, and underwent an ocular examination. Microbial culturing of the ocular surface, SCL, and lens storage case was conducted for all cases and one of the three matched controls. Univariate and multivariate logistic regression modeling were used to assess the risk of developing a CIE.RESULTS. Thirty cases and 90 controls 13 to 31 years of age completed the study. Corneal infiltrative event diagnosis included contact lens-associated red eye, infiltrative keratitis, and contact lens peripheral ulcer. Subjects with symptomatic CIEs were more likely to harbor substantial levels of gram-negative bioburden on the ocular surface and contact lens. Significant risk factors for developing a CIE were overnight wear of SCLs, use of multipurpose solution, rinsing SCLs with water, lens storage case older than 6 months, previous ''red eye'' event, use of ocular drops in the past week, and illness during the past week.CONCLUSIONS. This pilot study demonstrated feasibility of enrolling a representative pool of SCL wearers with an untreated, symptomatic CIE and assessing CIE risk factors by using standardized methods. A larger sample size is needed to determine relationships between patient-reported behaviors and exposures, microbial bioburden, and CIE development.Keywords: adverse events, contact lenses, corneal infiltrative events, microbial culturing A recent report from the US Centers for Disease Control and Prevention (CDC) called to light the substantial burden associated with contact lens-related complications.1 The CDC report estimated that contact lens-related keratitis results in nearly 1 million doctor visits each year and carries an associated cost of $175 million.1 This estimate does not include the additional ''costs'' to the patient such as pain or discomfort, missed school or work, and potential for permanent loss of vision.Approximately 37 million people in the United States currently wear contact lenses and, due to the increasing prevalence of myopia, more and younger patients are expected to begin wearing contact lenses to aid in its management. 2,3 Research has demonstrated that adult and pediatric patients can safely wear soft contact lenses (SCLs) within controlled trials, with relatively low rates of complications, especially for daily lens wear. 4,5 However, as with most medical devices, when contact lenses are used by the general population outside of controlled trials, the rate and types of complications increase. 1,[6][7][8] The increased risk of complications is likely caused by poor wear and care beha...

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Section: Discussionmentioning

confidence: 87%

Case-Control Pilot Study of Soft Contact Lens Wearers With Corneal Infiltrative Events and Healthy Controls

Richdale

Lam

Wagner

et al. 2016

Invest. Ophthalmol. Vis. Sci.

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“…The latter includes episodes of a painful red eye such as contact lens peripheral ulcer (CLPU), contact lens‐induced acute red eye (CLARE) with and without infiltrates, and infiltrative keratitis. Corneal infiltrative events (CIEs) are defined as a non‐infectious infiltration of white blood cells into the stroma, with accompanying hyperemia 108 . Microbial keratitis or infectious keratitis is a severe manifestation of CIE, but usually accounts for around 5% of all corneal infiltrative events in soft lens wearers, 109,110 although the ratio may be higher among orthokeratology lens wearers 96 .…”

Section: What Risks Are Associated With Myopia Control?mentioning

confidence: 99%

Myopia Control 2020: Where are we and where are we heading?

Bullimore

Richdale

2020

Ophthalmic Physiologic Optic

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Purpose: This review arms practitioners with the evidence-based information they need to fully manage myopia. Recent findings: The recent peer-reviewed literature is critically evaluated to provide a comprehensive analysis of the safety and efficacy of behavioural, optical and pharmaceutical myopia management. Importantly, the paper addresses not only who to treat, but how to treat them, and when to stop or modify treatments. Finally, the paper discusses expectations for treatment and why slowing myopia by even 1 dioptre improves long term health outcomes. Summary: The management of an individual child should be underpinned by the evidence-based literature and clinicians must stay alert to ongoing myopia research that will undoubtedly result in an evolution of the standard of care for the myopic and pre-myopic child.

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“…With modern studies where the prevalence of DDs is widespread and not simply limited to early adopters or patients prone to lens complications, DD lenses have indeed produced a reduction in risk for CIEs. The TEMPO registry study carried out by Chalmers and colleagues found very low rates of CIEs in DD wearers with a rate of 0.4 per cent per year in silicone hydrogel DD lenses, and zero per cent in hydrogel DD lenses . This is in comparison to CIE rates of 3.3–10.7 per cent with reusable lenses.…”

Section: Risk Factorsmentioning

confidence: 96%

“…This is in comparison to CIE rates of 3.3–10.7 per cent with reusable lenses. Overall, the annual rate of symptomatic CIEs in DD wearers was found to be 0.2 per cent . A retrospective multicentre study found that re‐useable daily wear lenses posed a 12.5 times higher risk of CIEs when compared to DD daily wear lenses.…”

Section: Risk Factorsmentioning

confidence: 99%

Epidemiology of contact lens‐induced infiltrates: an updated review

Steele

Szczotka-Flynn

2017

Clinical and Experimental Optometry

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Corneal infiltrative events (CIEs) are well established as a risk associated with soft contact lens wear. The incidence of symptomatic CIEs during extended soft lens wear ranges from 2.5 to six per cent; when asymptomatic CIEs are included, the incidence can be as high as 20-25 per cent. In daily soft lens wear, the annual incidence of symptomatic CIEs is about three per cent. There are various accepted methods of categorising CIEs, and a scoring system based on clinical signs and symptoms is a good approach to grade severity. Lensrelated risk factors include extended wear, silicone hydrogel material, the use of multipurpose solutions, bacterial bioburden and reusable lenses. Recent studies report that daily disposable lenses reduce the risk of CIEs.

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Rates of Adverse Events With Hydrogel and Silicone Hydrogel Daily Disposable Lenses in a Large Postmarket Surveillance Registry: The TEMPO Registry

Cited by 80 publications

References 48 publications

Case-Control Pilot Study of Soft Contact Lens Wearers With Corneal Infiltrative Events and Healthy Controls

Case-Control Pilot Study of Soft Contact Lens Wearers With Corneal Infiltrative Events and Healthy Controls

Myopia Control 2020: Where are we and where are we heading?

Epidemiology of contact lens‐induced infiltrates: an updated review

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