Use of a run-in period to decrease loss to follow-up in the contact lens and myopia progression (CLAMP) study

Jeffrey J Walline O.D., Ph.D., Lisa A Jones Ph.D., Donald O Mutti O.D., Ph.D., Karla Zadnik O.D., Ph.D.
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引用次数: 15

Abstract

Rigid gas permeable (RGP) contact lenses are initially less comfortable to wear than spectacles. In previous studies evaluating the use of RGP contact lenses to control myopia, more subjects randomly assigned to wear RGP contact lenses have been lost to follow-up than spectacle wearers. Previous rigid contact lens myopia control studies have lost 44% and 47% of the rigid contact lens wearers. This unequal loss to follow-up may compromise the results of the study, so we conducted a run-in period prior to randomized treatment-group assignment to ensure that all participants could adapt to RGP contact lens wear. We enrolled 147 children ages 8–11 years with myopia in the run-in period. Of the 147 subjects, 116 (78.9%) were able to wear RGP contact lenses for at least 40 hours per week and reported that they were “usually comfortable” or “always comfortable.” After 3 years, no subjects were lost to follow-up. The run-in period greatly reduced the loss to follow-up suffered by previous RGP contact lens myopia progression studies and may help provide more definitive answers regarding myopia control with RGP contact lenses.

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使用磨合期来减少隐形眼镜和近视进展(CLAMP)研究的随访损失
刚性透气性(RGP)隐形眼镜最初戴起来不如眼镜舒服。在先前评估使用RGP隐形眼镜控制近视的研究中,随机分配佩戴RGP隐形眼镜的受试者比眼镜佩戴者更容易失去随访。之前的硬性隐形眼镜近视控制研究已经失去了44%和47%的硬性隐形眼镜佩戴者。这种不平等的随访损失可能会影响研究结果,因此我们在随机治疗组分配之前进行了一段磨合期,以确保所有参与者都能适应RGP隐形眼镜佩戴。我们在磨合期招募了147名8-11岁的近视儿童。在147名受试者中,116名(78.9%)能够每周佩戴RGP隐形眼镜至少40小时,并报告他们“通常舒适”或“总是舒适”。3年后,没有受试者失去随访。磨合期大大减少了之前RGP隐形眼镜近视进展研究的随访损失,并可能有助于提供关于使用RGP隐形眼镜控制近视的更明确的答案。
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