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Clinical Trials |

A Randomized Trial of the Effects of Rigid Contact Lenses on MyopiaProgression

Jeffrey J. Walline, OD, PhD; Lisa A. Jones, PhD; Donald O. Mutti, OD, PhD; Karla Zadnik, OD, PhD
Arch Ophthalmol. 2004;122(12):1760-1766. doi:10.1001/archopht.122.12.1760.
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Published online

Objective  To compare the effects of rigid gas-permeable contact lenses (RGPs)and soft contact lenses (SCLs) on myopia progression in children.

Methods  We randomly assigned 116 subjects to wear RGPs or SCLs. Subjects underwentcycloplegic autorefraction, keratometry, and A-scan ultrasonographic axiallength measurements at each annual visit. All analyses were conducted accordingto the original randomization assignment. The primary outcome measure wasthe 3-year change in spherical equivalent cycloplegic autorefraction.

Results  The mean ± SD spherical equivalent cycloplegic refractiveerror progressed –1.56 ± 0.95 diopters (D) for RGPwearers and –2.19 ± 0.89 D for the SCL wearers duringthe 3 years of the study (analysis of covariance [ANCOVA], P<.001). The axial growth of the eyes was not significantly differentbetween treatment groups (ANCOVA, P = .57).The steep corneal meridian of the RGP wearers steepened 0.62 ± 0.60D, and that of the SCL wearers steepened 0.88 ± 0.57 D duringthe 3 years (ANCOVA, P = .01).

Conclusions  The RGP wearers’ myopia progressed less than that of the SCL wearers.The corneal curvature of the SCL wearers steepened more than that of the RGPwearers, but the axial growth was not significantly different between thegroups. Most refractive error treatment effect was limited to the first yearof the trial. The results of the study provide information for eye care practitionersto share with their patients, but they do not indicate that RGPs should beprescribed primarily for myopia control.

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Figure 1.

Flow diagram of subjects in the ContactLens and Myopia Progression Study. RGPs indicates rigid gas-permeable contactlens; SCLs, soft contact lenses.

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Figure 2.

A, Mean ± SD cycloplegicspherical equivalent refractive error for wearers of rigid gas-permeable contactlenses (RGPs) and soft contact lenses (SCLs). The shaded portion representsthe run-in period, when all subjects wore RGPs. The asterisks indicate a significantdifference in refractive error between treatment groups (P<.05). B, Mean ± SD curvature of the steepcorneal meridian for RGP and SCL wearers from the initial visit to the endof the study. The shaded portion represents the run-in period, when all subjectswore RGPs. The asterisks indicate a significant difference in corneal curvaturebetween treatment groups (P<.05). The dashedline indicates the initial curvature of the steep corneal meridian. Cornealflattening is seen during the run-in period, with a return to the initialcorneal curvature for the RGP wearers, and the additional steepening in theSCL wearers. C, Mean ± SD axial length for RGP and SCL wearersfrom the initial visit to the end of the study. Axial lengths were not measuredat the initial visit, so no axial length data were available before randomization.There were no significant differences between the treatment groups at anyof the visits (P<.05).

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