DISC Study 2011.
Study characteristics | |
Methods | Study design: parallel‐group RCT Study centre: 1 (Hong Kong Polytechnic University) Number randomised: 221 children Study follow‐up: 2 years Exclusions and losses to follow‐up: 38 (34.2 %) in BFSCL group and 36 (32.7%) in SVSCL group were excluded; 8 (7.2 %) in BFSCL group and 11 (10.0%) in SVSCL group were lost to follow‐up |
Participants | Age: mean = 11 years (range 8‐13 years) Gender: 85 boys, 136 girls Culture: Hong Kong, China Inclusion criteria:
Exclusion criteria:
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Interventions | BFSCL group (n = 111): dual‐focus incorporated soft contact (DISC) lenses, which were custom‐made BFSCLs with distance correction in the centre and alternating rings of defocusing (+2.50 D addition) and distance correction zones SVSCL group (n = 110): SVSCLs Note: children were instructed to wear lenses for 5‐10 h/day and to wear spectacles with full prescription when not wearing contact lenses |
Outcomes |
Primary outcomes
Secondary outcome
Measurements taken every 6 months over 2 years Unit of analysis: individual (right eye used for analysis) |
Notes | Study dates: September 2007‐ October 2009 Trial registration: NCT00919334 Funding source: "the study was supported by grants of RGC GRF (B‐Q04G) and Niche Areas Fund (J‐BB7P) from The Hong Kong Polytechnic University" Conflict of interest: reported "none" |