Postmarket Surveillance of Menicon Z Rigid Gas-Permeable Contact Lenses for up to 30 Days Continuous Wear in the United States

Albright, Roger; Venuti, Beverley D.; Ichijima, Hideji; Nyunt, Aung Kyaw; Cavanagh, Harrison D

doi:10.1097/icl.0b013e3181efa61b

Cited by 5 publications

(7 citation statements)

References 25 publications

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“…Even in 12-month studies in which CLs and supplies are provided free of charge, combined discontinuation and loss to follow-up rates between 32% and 36% have been reported. 9,14,27 The TEMPO Registry's retention at 82.3% is also slightly better than the 80% reported in a similarly designed study that was carried out a decade ago, 5,6 most likely due to improved ability to contact wearers electronically and allow them to submit their responses online. The registry encountered so few CIE events that our planned regression analysis to determine risk factors was not very fruitful.…”

Section: Discussionmentioning

confidence: 57%

“…24 Postmarket surveillance is not typically required for CLs, but can be mandated under the FDA 522 guidelines. 25,26 In recent history, active postmarketing surveillance was mandated for three manufacturers of CLs that carried an indication for 30 nights of continuous wear 6,27 and for lenses that were used primarily by pediatric populations. 28 Occasionally, these mandates follow the publication of case reports from the literature indicating a safety concern during normal clinical use, as in the case of overnight orthokeratology.…”

mentioning

confidence: 99%

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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

Chalmers

Hickson-Curran

Keay

et al. 2015

Investigative Ophthalmology & Visual Science

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Section: Discussionmentioning

confidence: 57%

mentioning

confidence: 99%

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

Chalmers

Hickson-Curran

Keay

et al. 2015

Investigative Ophthalmology & Visual Science

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“…To address these issues, current rigid lenses are the rigid‐gas‐permeable (RGP) lenses made up of, for example, silicone acrylates or fluoro‐silicone/acrylate, which combined the advantages of both silicone (oxygen permeability) and PMMA (accessible manufacture) 14 . In 2010, Menicon Z contact lenses were the only rigid lenses that received FDA's approval for 30 days of continuous usage 15 . Compared to rigid lenes, soft lenses are more comfortable and have higher flexibility.…”

Section: Properties and Classification Of Contact Lensmentioning

confidence: 99%

Innovative advancement of contact lenses for noninvasive diagnosis and therapy: A mini review

Wen

Liu

Zhang

2023

MedComm – Biomaterials and Applications

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With the growth of the market and the number of wearers, contact lenses have been widely used for vision correction and cosmetic purposes for a few years. The current study opens up a new path for their applications. On the one hand, contact lenses are ideal sensing platforms due to advances in the monitoring of relevant indicators in tears such as glucose and intraocular pressure. Aside from detecting a single analyte at a time, multifunctional contact lens sensors were proposed to monitor two or more indicators at the same time. Contact lenses, on the other hand, are also suitable drug delivery platforms due to their good biocompatibility and long contact duration with the cornea. Different drug delivery approaches are being investigated to increase drug duration and bioavailability. In addition, the integration of these novel drug delivery methods into wearable sensors has become a topic for a complete closed‐loop program for disease management. We began this review by summarizing the categories and properties of current contact lenses. Then, innovative applications of contact lenses such as biosensors and drug delivery systems were also summarized. In general, the current progress in the applications of contact lenses provides a new possibility for noninvasive diagnosis and therapy of ocular diseases.

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“…[2][3][4][5][6][7] Table 3 shows the details from those FDA-mandated postapproval studies that generally found no change in the rate of microbial keratitis in the silicone hydrogel lenses with 30 nights of wear compared with hydrogels with 7 nights of overnight wear and an undetectable rate of microbial keratitis in the smaller RGP study. Its searchable database content is described on the FDA website thus: "MAUDE data represents reports of adverse events involving medical devices.…”

mentioning

confidence: 99%

Overview of Contact Lens Postmarket Surveillance in the United States

Chalmers

Gleason

2013

Eye &Amp; Contact Lens: Science &Amp; Clinical Practice

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This is an overview of the US contact lens (CL) postmarket surveillance systems and surveillance study results that include silicone hydrogel CLs. As 30-night continuous wear silicone hydrogel and rigid gas-permeable (RGP) CLs were approved for use in the United States in 2001, the Food and Drug Administration (FDA) mandated large postmarket surveillance studies to assess the risk of microbial keratitis with those products when worn with the 30-night wearing schedule. Since the time of the approvals, RGP 30-night wear has been used sparingly and a shift from 30-night wear has occurred for silicone hydrogel lenses. Several silicone hydrogel lenses have been approved and most of these lenses are being prescribed for daily or flexible wear and not for 30-night wear. With daily wear and less overnight use, silicone hydrogel lenses are regularly exposed to lens care products, lens cases, and improper handling, all of which may introduce sources of microbial contamination that could trigger lens-related complications. This summary of CL postmarket surveillance system and methods gives results of FDA-mandated surveillance and of recent US studies that observed "real-world" populations for safety results outside the bounds of highly controlled prospective clinical trials.

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Postmarket Surveillance of Menicon Z Rigid Gas-Permeable Contact Lenses for up to 30 Days Continuous Wear in the United States

Abstract: On the basis of this study, CW of the Menicon Z hyper-Dk/t RGP lens provides a safe and full-time vision correction alternative for patients who can adapt to RGP lens wear.

Cited by 5 publications

References 25 publications

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

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

Innovative advancement of contact lenses for noninvasive diagnosis and therapy: A mini review

Overview of Contact Lens Postmarket Surveillance in the United States

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