Anstice 2011.
Study characteristics | ||
Methods | Study design: paired‐eye, cross‐over RCT Study center: 1 Number randomized: 40 children Study follow‐up: 20 months (10 months for each period) Exclusions and losses to follow‐up: no exclusions; 5 (12.5%) and 6 (15.0%) were lost to follow‐up at 10‐month visit and 20‐month visit, respectively |
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Participants | Age: mean = 13.4 years (range 11 to 14 years) Gender: 11 boys, 29 girls Culture: New Zealand, including East Asian ethnicity and others (European, Indian, and Maori/Pacifica) Inclusion criteria: (1) 11 to 14 years old at recruitment; (2) spherical equivalent between ‐1.25 and ‐4.50 D in the least myopic eye as determined by noncycloplegic subjective refraction; (3) myopia progression ≥ 0.50 D in the previous 12 months; (4) best‐corrected spectacle visual acuity of Snellen 6/6 or better in each eye; (5) willingness to wear contact lenses for ≥ 8 hours per day during the study Exclusion criteria: history of (1) astigmatism ≥ 1.25 D; (2) anisometropia ≥ 1.00 D; (3) strabismus at distance or near as assessed by cover test; (4) ocular or systemic pathology likely to affect refractive development or successful contact lens wear; (5) birth weight ≤ 1250 g |
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Interventions | Group 1 (n = 21): 10 months wearing 2.00 D dual‐focus (DF) contact lens in the dominant eye and SVSCL in the contralateral eye, followed by 10 months wearing the swapped lens assignment Group 2 (n = 19): 10 months wearing DF contact lens in the nondominant eye and SVSCL in the contralateral eye, followed by 10 months wearing the swapped lens assignment |
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Outcomes |
Primary outcome:
Secondary outcome:
Measurements taken at baseline and every 5 months for 20 months Unit of analysis: data analyzed by dominant eye |
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Notes | Study dates: 2005 to not reported
Trial registration: ACTRN12605000633684 Funding source: Maurice and Phyllis Paykel Trust; New Zealand Optometric and Vision Research Foundation; Cornea and Contact Lens Society of New Zealand Notes: study is also known as the Dual‐focus Inhibition of Myopia Evaluation in New Zealand (DIMENZ) study |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Children were randomized into group 1 or group 2 using a permuted block design with a block size of 4" |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment was not reported |
Masking of participants (performance bias) | High risk | "The participants and the optometrist responsible for clinical care were not masked to lens assignment" |
Masking of outcome assessors (detection bias) Progression of myopia | Low risk | The "investigating optometrists responsible for making outcome measures were masked" |
Masking of outcome assessors (detection bias) Secondary outcomes | Low risk | The "investigating optometrists responsible for making outcome measures were masked" |
Masking of data analyzers | Unclear risk | This was not reported |
Incomplete outcome data (attrition bias) Incomplete outcome(s) data | Low risk | Six participants (15%)—3 from each group—were lost to followup and were excluded from the analysis: 4 children due to difficulties handling the contact lenses, 1 due to negative publicity on contact lens solutions, and 1 due to dislike of cycloplegia |
Selective reporting (reporting bias) | Low risk | All outcomes specified prospectively on a clinical trials registry were reported |
Other bias | High risk | One of the study authors disclosed an inventor patent for the contact lens design. Data were not appropriately analyzed for paired‐eye nor cross‐over design |