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 SCL

SUBMITTER: Chalmers RL 

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

REPOSITORIES: biostudies-literature