The wearing of contact lenses has increased dramatically in the past decade; over 4 million people in the United States now use extended-wear soft contact lenses, and 9 million use daily-wear soft contact lenses. Numerous reports have caused concern that the use of soft contact lenses, especially extended-wear lenses, may result in a substantial risk of ulcerative keratitis. To examine this issue, we conducted a prospective study in five New England states to estimate the incidence of ulcerative keratitis among those who use cosmetic extended-wear and daily-wear soft contact lenses. To obtain the numerator for each estimate of incidence, we surveyed all practicing ophthalmologists in the study area to identify all new cases diagnosed over a four-month period. To provide the denominator, we conducted a survey of 4178 households to estimate the number of persons who wore each type of soft contact lens. The annualized incidence of ulcerative keratitis was estimated to be 20.9 per 10,000 persons using extended-wear soft contact lenses for cosmetic purposes and 4.1 per 10,000 persons using daily-wear soft contact lenses for cosmetic purposes (P less than 0.00001).

Over 13 million people in the United States wear soft contact lenses for refractive correction. Ulcerative keratitis is considered the most serious adverse effect of the use of contact lenses. We performed a case-control study with 86 cases patients, estimating separately for hospital-based (n = 61) and population-based (n = 410) controls the relative risk of ulcerative keratitis among users of extended-wear as compared with daily-wear soft contact lenses. The relative risk of ulcerative keratitis for extended-wear as compared with daily-wear lenses among the population-based controls was 3.90 (95 percent confidence interval, 2.35 to 6.48) and among the hospital-based controls, 4.21 (95 percent confidence interval, 1.95 to 9.08). Thirty-eight percent of those with extended-wear lenses used them only during the day, and 11 percent of those with daily-wear lenses occasionally wore them overnight. When lens wearers were distinguished according to their overnight use of lenses, the users of extended-wear lenses who wore them overnight had a risk 10 to 15 times as great as the users of daily-wear lenses who did not, and the users of daily-wear lenses who sometimes wore them overnight had 9 times the risk of the users of such lenses who did not. For the users of extended-wear lenses, the risk of ulcerative keratitis was incrementally related to the extent of overnight wear. A reduction in risk associated with more frequent attention to lens hygiene was almost significant. We conclude that soft contact lenses worn overnight carry a significantly greater risk for ulcerative keratitis than soft lenses worn only during the day.

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