A meta-analysis of studies on cosmetically tinted soft contact lenses

Abstract

BackgroundConcerns regarding the safety of cosmetically tinted contact lenses have been reported in the literature. The purpose of this paper is to evaluate the safety of cosmetically tinted contact lenses in a large number of patients across six clinical trials that varied from 1 week to 3 months in duration.MethodsLenses tested included: Naturelle limbal ring daily disposable, Lacelle limbal ring daily disposable, Lacelle colored cosmetic daily disposable, Lacelle limbal ring planned replacement at 2 weeks, and Alamode traditional/annual colored cosmetic lens. The primary safety outcome was slit-lamp examination, including epithelial edema, epithelial microcysts, corneal staining, bulbar injection, limbal injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates. High contrast logMAR visual acuity with lenses, and lens wearing time, movement, and centration, are also presented.ResultsA total of 871 subjects (1,742 eyes) and 23 clinical investigators participated in the six studies, with an average completion rate of 96.4% across all studies. The mean age of the patients was 26.8 ± 6.6 years, and 86.7% of participants were female. The total number of slit-lamp examinations across the six studies was 2,456 visits by eye (1,228 visits by patient). There were no slit-lamp signs > grade 2 for any finding, with the exception of corneal staining in one study. In this study, grade 3 corneal staining was noted in one eye (0.1%) at follow-up visit 1 and four (0.6%) of all eligible dispensed eyes at follow-up visit 2, with no eyes requiring medical treatment. No adverse events were reported during any of the trials.ConclusionThe cosmetically tinted lenses evaluated in this meta-analysis appear to be safe when properly prescribed by an eye care professional and used in a compliant manner.

Effect of the pigment-free optical zone diameter of decorative tinted soft contact lenses on visual function

“…In most Asian countries, approximately one-third of all contact lens wearers use decorative tinted soft contact lenses and the market share for this segment has contributed significantly to the rapid growth 1 2. A decorative tinted soft contact lens contains a central pigment-free optical zone and a peripheral pigment-tinted area.…”

<p>Use and misuse of cosmetic contact lenses among US adolescents in Southeast Texas</p>

“…Since they are classified as medical devices in the USA, purchasing CCL requires a prescription. However, as they are worn solely for cosmetic purposes, users may incorrectly assume that consultation with an eye care professional is not required 2,5. As a result, users may purchase CCL from vendors who are not licensed to sell contact lenses or may obtain them from friends or family members 5,6.…”

“…However, as they are worn solely for cosmetic purposes, users may incorrectly assume that consultation with an eye care professional is not required 2,5. As a result, users may purchase CCL from vendors who are not licensed to sell contact lenses or may obtain them from friends or family members 5,6. Little is known about these practices, however, as almost no studies have been conducted on this topic 6.…”

A web-based survey of contact lens-related adverse events among Japanese female population: Are decorative contact lenses dangerous?

“…The safety of cosmetic CLs is controversial. More speci cally, there have been several negative reports about adverse events related to the use of DCLs [3][4][5].A recently published meta-analysis that was conducted by a manufacturing company about their own products summarized six, unpublished results regarding the safety of their DCLs and concluded that they were safe [6]. This report, as written, would be insu cient as a meta-analysis document because it did not provide the calculation of pooled odds ratios or relative risk assessment.…”