Adverse event rates in the retrospective cohort study of safety of paediatric soft contact lens wear: the ReCSS study
| Autor: | John McNally, Lisa Keay, Paul Chamberlain, Robin L. Chalmers |
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| Rok vydání: | 2020 |
| Předmět: |
Male
medicine.medical_specialty Pediatrics paediatric Visual acuity Adolescent Eye Infections Bacterial 03 medical and health sciences 0302 clinical medicine Prosthesis Fitting Epidemiology Myopia medicine Humans myopia control contact lenses Medical prescription Child Corneal Ulcer Disposable Equipment Adverse effect Retrospective Studies Inflammation business.industry Retrospective cohort study Original Articles Contact Lenses Hydrophilic adverse events Sensory Systems Contact lens Clinical trial Ophthalmology Cohort 030221 ophthalmology & optometry Original Article epidemiology Female medicine.symptom business 030217 neurology & neurosurgery Follow-Up Studies Optometry |
| Zdroj: | Ophthalmic & Physiological Optics |
| ISSN: | 1475-1313 0275-5408 |
| DOI: | 10.1111/opo.12753 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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