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Clinical Trial
. 2015:2015:507572.
doi: 10.1155/2015/507572. Epub 2015 Oct 28.

Myopia Control with a Novel Peripheral Gradient Soft Lens and Orthokeratology: A 2-Year Clinical Trial

Jaime Pauné  1 , Hari Morales  1 , Jesús Armengol  2 , Lluisa Quevedo  2 , Miguel Faria-Ribeiro  3 , José M González-Méijome  3
Affiliations
Clinical Trial

Myopia Control with a Novel Peripheral Gradient Soft Lens and Orthokeratology: A 2-Year Clinical Trial

Jaime Pauné et al. Biomed Res Int. 2015.

Abstract

Objective: To evaluate the degree of axial elongation with soft radial refractive gradient (SRRG) contact lenses, orthokeratology (OK), and single vision (SV) spectacle lenses (control) during a period of 1 year before treatment and 2 years after treatment.

Methods: This was a prospective, longitudinal, nonrandomized study. The study groups consisted of 30, 29, and 41 children, respectively. The axial length (AL) was measured during 2 years after recruitment and lens fitting.

Results: The baseline refractive sphere was correlated significantly (Spearman's Rho (ρ) correlation = 0.542; P < 0.0001) with the amount of myopia progression before baseline. After 2 years, the mean myopia progression values for the SRRG, OK, and SV groups were -0.56 ± 0.51, -0.32 ± 0.53, and -0.98 ± 0.58 diopter, respectively. The results represent reductions in myopic progression of 43% and 67% for the SRRG and OK groups, respectively, compared to the SV group. The AL increased 27% and 38% less in the SRRG and OK groups, respectively compared with the SV group at the 2-year visit (P < 0.05). Axial elongation was not significantly different between SRRG and OK (P = 0.430).

Conclusion: The SRRG lens significantly decreased AL elongation compared to the SV control group. The SRRG lens was similarly effective to OK in preventing myopia progression in myopic children and adolescent.

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Figures

Figure 1
Figure 1
Flow diagram of study progress in the SRRG, OK and SV groups.
Figure 2
Figure 2
Increase in M from 1 year before treatment against baseline RPRE (M value at the temporal and nasal retina). Correlations were statistically significant for the temporal and nasal RPRE (P < 0.01 and P < 0.05, resp.). Every 1.00 D of hyperopic RPRE temporal M value is related to a −0.10 D extra increase in annual M value. The dotted line indicates the regression of the RPRE-T (temporal retina) and the dashed line indicates the RPRE-N (nasal retina).
Figure 3
Figure 3
AL increase in relation to the RPRE in the nasal and temporal retina measured through the SRRG (experimental group) and SV (control group). The black diamonds indicate the RPRE-T (temporal retina); the grey squares indicated the RPRE-N (nasal retina); the dotted line indicates the regression of the RPRE-T; and the dashed line indicates the RPRE-N.
Figure 4
Figure 4
Mean and SD of myopic progression (spherical equivalent refraction).
Figure 5
Figure 5
Mean and SD of AL progression (mm).
Figure 6
Figure 6
Mean and SD of the VCD changes (mm).
See this image and copyright information in PMC

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