Dataset Information

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

ABSTRACT:

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.

SUBMITTER: Chalmers RL

PROVIDER: S-EPMC7839756 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

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

Chalmers Robin L RL McNally John J JJ Chamberlain Paul P Keay Lisa L

Ophthalmic & physiological optics : the journal of the British College of Ophthalmic Opticians (Optometrists) 20201111 1

<h4>Purpose</h4>To ascertain the safety of soft contact lens (SCL) wear in children through a retrospective chart review including real-world clinical practice settings.<h4>Methods</h4>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. Cli ...[more]

PMID: 33179359

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Dataset Information

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

Purpose

Methods

Results

Conclusion

Publications

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

Similar Datasets

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