Adverse event rates in the retrospective cohort study of safety of paediatric soft contact lens wear: the ReCSS study.

PURPOSE: To ascertain the safety of soft contact lens (SCL) wear in children through a retrospective chart review including real-world clinical practice settings. METHODS: The study reviewed clinical charts from 963 children: 782 patients in 7 US eye care clinics and 181 subjects from 2 international randomised clinical trials (RCTs). Subjects were first fitted while 8-12 years old with various SCL designs, prescriptions and replacement schedules, and observed through to age 16. Clinical records from visits with potential adverse events (AEs) were electronically scanned and reviewed to consensus by an Adjudication Panel. RESULTS: The study encompassed 2713 years-of-wear and 4611 contact lens visits. The cohort was 46% male, 60% were first fitted with daily disposable SCLs, the average age at first fitting was 10.5 years old, with a mean of 2.8 ± 1.5 years-of-wear of follow-up observed. There were 122 potential ocular AEs observed from 118/963 (12.2%) subjects; the annualised rate of non-infectious inflammatory AEs was 0.66%/year (95% CI 0.39-1.05) and 0.48%/year (0.25-0.82) for contact lens papillary conjunctivitis. After adjudication, two presumed or probable microbial keratitis (MK) cases were identified, a rate of 7.4/10 000 years-of-wear (95% CI 1.8-29.6). Both were in teenage boys and one resulted in a small scar without loss of visual acuity. CONCLUSION: This study estimated the MK rate and the rate of other inflammatory AEs in a cohort of SCL wearers from 8 through to 16 years of age. Both rates are comparable to established rates among adults wearing SCLs.

Risk factors for corneal infiltrates with continuous wear of contact lenses.

PURPOSE: To describe the factors associated with symptomatic corneal infiltrates in a postmarket surveillance study of continuous wear contact lenses. METHODS: Patients intending to wear lotrafilcon A lenses continuously for 30 days and nights were registered in a 1-year study at 131 clinical sites. A self-administered questionnaire was used to gather demographic and other data at baseline. The severity of the incidence of corneal infiltrative events during the year-long study was graded by an independent adjudication committee. RESULTS: Of 6245 lens wearers, 163 were reported to have symptomatic corneal infiltrative events (2.6%). In 159 wearers, the infiltrates were judged to be lens-related (2.5%). Age < or =25 years and >50 years was significantly associated with the development of corneal infiltrates (< or =25 years OR = 1.75, 95% CI = 1.24-2.48 and >50 years OR = 2.04, 95% CI = 1.40-2.98). Ametropia of > or =5.00 D was significantly associated with corneal infiltrates (OR = 1.60, 95% CI = 1.08-2.37). Study participants who typically wore lenses for >21 consecutive days and nights were significantly less likely to have infiltrates than those who wore lenses for fewer consecutive days and nights (OR = 0.43, 95% CI = 0.24-0.75). Smoking concurrent with contact lens wear was weakly associated with corneal infiltrates (OR = 1.47, CI = 0.99-2.18). CONCLUSIONS: Patient age, degree of refractive error, and failure to achieve the intended wearing schedule were associated with development of symptomatic corneal infiltrative events.

The incidence of microbial keratitis among wearers of a 30-day silicone hydrogel extended-wear contact lens.

PURPOSE: To estimate the incidence of presumed microbial keratitis with and without loss of visual acuity among wearers of a silicone hydrogel contact lens (Lotrafilcon A, Night & Day, CIBA Vision, Inc., Duluth, GA), recently approved for up to 30 days of continuous wear. DESIGN: Prospective cohort postmarket surveillance study. PARTICIPANTS: Contact lens wearers (recruited from 131 practices) who had been prescribed the lens for intended continuous wear of as many as 30 nights. METHODS: The occurrence of a corneal infiltrate was ascertained through a combination of center report and direct contact with participants at 3 and 12 months. Whenever a corneal infiltrate was suspected, study and treatment medical records were systematically reviewed by an Endpoints Committee using a predetermined classification scheme for corneal infiltration. Cases of presumed microbial keratitis were determined based on the constellation of presenting signs and symptoms and clinical course. MAIN OUTCOME MEASURES: The incidence of presumed microbial keratitis with and without loss of visual acuity. RESULTS: A total of 6245 participants were recruited between August 13, 2002 and July 2, 2003. Of these, 4999 subjects (80%) completed 12 months of follow-up, and these participants contributed a total of 5561 person years of lens wearing experience. Approximately 80% of participants routinely wore their lenses continuously for 3 or more weeks. The overall annual rate of presumed microbial keratitis was 18 per 10,000 (95% confidence interval (CI): 8.5-33.1). There were 2 cases of presumed microbial keratitis with loss of visual acuity, an annual rate of 3.6 per 10,000 (95% CI: 0.4-12.9), and an additional 8 cases without loss of visual acuity, an annual rate of 14.4 per 10000 (95% CI: 6.1-28.4). The rate of presumed microbial keratitis was lower for users reporting typical wear of 3 or more weeks than for those wearing the lens for less than a 3-week continuous period (P = 0.02). CONCLUSIONS: The incidence of loss of visual acuity due to microbial keratitis among users of the silicone hydrogel contact lens was low. The overall rate of presumed microbial keratitis with the wearing schedule of as many as 30 nights was similar to that previously reported for conventional extended-wear soft lenses worn for fewer consecutive nights.

Risk factors for corneal infiltrative events with 30-night continuous wear of silicone hydrogel lenses.

PURPOSE: This analysis reports on risk factors for corneal infiltrative events from a 1-year, randomized clinical trial of lotrafilcon A lenses. METHODS: Six hundred fifty-eight subjects randomized to lotrafilcon A lenses were observed in a 1-year clinical trial in the United States. Risk factors gathered at baseline were analyzed to determine their association with corneal infiltrative events. RESULTS: Factors examined but not found to be associated with events were male sex, history of extended or daily lens wear, refractive error, neovascularization, or assessment of lens fit. Significant factors included subject age 18 to 29 years, smoking, smoking and young age combined, history of corneal scar, contact lens acute red eye (CLARE), and corneal infiltrates. CONCLUSION: Risk factors for corneal infiltrative events with silicone hydrogel lenses worn for 30 nights of continuous wear have been identified. Wearers with a history of inflammatory events such as contact lens peripheral ulcer or CLARE should consider 30-night continuous wear with these lenses. Careful counseling of wearers who smoke is advised.