{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,8]],"date-time":"2026-09-08T09:52:58Z","timestamp":1788861178214,"version":"build-2803163510"},"reference-count":27,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2020,11,11]],"date-time":"2020-11-11T00:00:00Z","timestamp":1605052800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Ophthalmic Physiologic Optic"],"published-print":{"date-parts":[[2021,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>To ascertain the safety of soft contact lens (SCL) wear in children through a retrospective chart review including real\u2010world clinical practice settings.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>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\u201312\u00a0years 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The study encompassed 2713\u00a0years\u2010of\u2010wear 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\u00a0years old, with a mean of 2.8\u00a0\u00b1\u00a01.5\u00a0years\u2010of\u2010wear of follow\u2010up observed. There were 122 potential ocular AEs observed from 118\/963 (12.2%) subjects; the annualised rate of non\u2010infectious inflammatory AEs was 0.66%\/year (95% CI 0.39\u20131.05) and 0.48%\/year (0.25\u20130.82) for contact lens papillary conjunctivitis. After adjudication, two presumed or probable microbial keratitis (MK) cases were identified, a rate of 7.4\/10\u00a0000\u00a0years\u2010of\u2010wear (95% CI 1.8\u201329.6). Both were in teenage boys and one resulted in a small scar without loss of visual acuity.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>This study estimated the MK rate and the rate of other inflammatory AEs in a cohort of SCL wearers from 8 through to 16\u00a0years of age. Both rates are comparable to established rates among adults wearing SCLs.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/opo.12753","type":"journal-article","created":{"date-parts":[[2020,11,12]],"date-time":"2020-11-12T02:34:25Z","timestamp":1605148465000},"page":"84-92","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":27,"title":["Adverse event rates in the retrospective cohort study of safety of paediatric soft contact lens wear: the ReCSS study"],"prefix":"10.1007","volume":"41","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3724-5872","authenticated-orcid":false,"given":"Robin L","family":"Chalmers","sequence":"first","affiliation":[{"name":"Clinical Trial Consultant Atlanta USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John J","family":"McNally","sequence":"additional","affiliation":[{"name":"CooperVision, Inc. Pleasanton USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Chamberlain","sequence":"additional","affiliation":[{"name":"CooperVision, Inc. Pleasanton USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa","family":"Keay","sequence":"additional","affiliation":[{"name":"School of Optometry and Vision Science UNSW Sydney Sydney NSW Australia"},{"name":"The George Institute for Global Health UNSW Sydney Sydney NSW Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,11,11]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ophtha.2010.10.035"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1097\/OPX.0000000000000036"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1097\/OPX.0000000000000808"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1097\/OPX.0000000000001410"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00417-018-3906-z"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/opo.12621"},{"key":"e_1_2_8_8_1","unstructured":"https:\/\/www.accessdata.fda.gov\/cdrh_docs\/pdf18\/P180035A.pdf."},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clae.2019.11.002"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.optm.2010.11.001"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ophtha.2008.04.002"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1097\/00003226-200307000-00009"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1097\/OPX.0b013e3182142396"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1097\/OPX.0b013e31821ffe14"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1167\/iovs.10-7018"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1097\/OPX.0b013e3181f31f68"},{"key":"e_1_2_8_17_1","unstructured":"Use of Real\u2010World Evidence to Support Decision\u2010Making for Medical Devices.Guidance for Industry and Food and Drug Administration Staff. 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