Effect of High Add Power, Medium Add Power, or Single-Vision Contact Lenses on Myopia Progression in Children: The BLINK Randomized Clinical Trial
| Autor: | Jeffrey J. Walline, Amber Gaume Giannoni, Katherine M. Bickle, Alex D Nixon, David A. Berntsen, Loraine T. Sinnott, Donald O. Mutti, Krystal L. Schulle, Gilbert E. Pierce, Lisa A. Jones-Jordan, Maria K. Walker |
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| Rok vydání: | 2020 |
| Předmět: |
Male
medicine.medical_specialty Refractive error Time Factors genetic structures Spherical equivalent Astigmatism Refraction Ocular 01 natural sciences law.invention 03 medical and health sciences 0302 clinical medicine Primary outcome Randomized controlled trial Double-Blind Method law Ophthalmology medicine Myopia Eye growth Humans 030212 general & internal medicine 0101 mathematics Trial registration Child Ohio business.industry 010102 general mathematics General Medicine medicine.disease Contact Lenses Hydrophilic Texas eye diseases Treatment Outcome Sample size determination Sample Size Disease Progression Linear Models Female business |
| Zdroj: | JAMA. 324(6) |
| ISSN: | 1538-3598 |
| Popis: | Importance Slowing myopia progression could decrease the risk of sight-threatening complications. Objective To determine whether soft multifocal contact lenses slow myopia progression in children, and whether high add power (+2.50 D) slows myopia progression more than medium (+1.50 D) add power lenses. Design, Setting, and Participants A double-masked randomized clinical trial that took place at 2 optometry schools located in Columbus, Ohio, and Houston, Texas. A total of 294 consecutive eligible children aged 7 to 11 years with −0.75 D to −5.00 D of spherical component myopia and less than 1.00 D astigmatism were enrolled between September 22, 2014, and June 20, 2016. Follow-up was completed June 24, 2019. Interventions Participants were randomly assigned to wear high add power (n = 98), medium add power (n = 98), or single-vision (n = 98) contact lenses. Main Outcomes and Measures The primary outcome was the 3-year change in cycloplegic spherical equivalent autorefraction, as measured by the mean of 10 autorefraction readings. There were 11 secondary end points, 4 of which were analyzed for this study, including 3-year eye growth. Results Among 294 randomized participants, 292 (99%) were included in the analyses (mean [SD] age, 10.3 [1.2] years; 177 [60.2%] were female; mean [SD] spherical equivalent refractive error, −2.39 [1.00] D). Adjusted 3-year myopia progression was −0.60 D for high add power, −0.89 D for medium add power, and −1.05 D for single-vision contact lenses. The difference in progression was 0.46 D (95% CI, 0.29-0.63) for high add power vs single vision, 0.30 D (95% CI, 0.13-0.47) for high add vs medium add power, and 0.16 D (95% CI, −0.01 to 0.33) for medium add power vs single vision. Of the 4 secondary end points, there were no statistically significant differences between the groups for 3 of the end points. Adjusted mean eye growth was 0.42 mm for high add power, 0.58 mm for medium add power, and 0.66 mm for single vision. The difference in eye growth was −0.23 mm (95% CI, −0.30 to −0.17) for high add power vs single vision, −0.16 mm (95% CI, −0.23 to −0.09) for high add vs medium add power, and −0.07 mm (95% CI, −0.14 to −0.01) for medium add power vs single vision. Conclusions and Relevance Among children with myopia, treatment with high add power multifocal contact lenses significantly reduced the rate of myopia progression over 3 years compared with medium add power multifocal and single-vision contact lenses. However, further research is needed to understand the clinical importance of the observed differences. Trial Registration ClinicalTrials.gov Identifier:NCT02255474 |
| Databáze: | OpenAIRE |
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