Safety and efficacy of 2% pirenzepine ophthalmic gel in children with myopia - A 1-year, multicenter, double-masked, placebo-controlled parallel study
ABSTRACT To evaluate the safety and efficacy of the relatively selective M(1) antagonist pirenzepine hydrochloride in slowing the progression of myopia in school-aged children.
This was a parallel-group, placebo-controlled, double-masked study in healthy children, aged 8 to 12 years, with a spherical equivalent of -0.75 to -4.00 diopters (D) and astigmatism of 1.00 D or less. Patients underwent a baseline complete eye examination and regular examinations during a 1-year period. The setting was 13 US academic clinics and private practices. Patients were randomized in a 2:1 ratio to receive 2% pirenzepine ophthalmic gel or a placebo control twice daily for 1 year.
At study entry, the spherical equivalent was mean +/- SD -2.098 +/- 0.903 D for the pirenzepine group (n = 117) and -1.933 +/- 0.825 D for the placebo group (n = 57, P = .22). At 1 year, there was a mean increase in myopia of 0.26 D in the pirenzepine group vs 0.53 D in the placebo group (P < .001). No patients in the placebo group and 13 (11%) of 117 patients in the pirenzepine group discontinued participation in the study because of adverse effects (5 [4%] of 117 due to excessive antimuscarinic effects).
Pirenzepine is effective and relatively safe in slowing the progression of myopia during a 1-year treatment period.
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ABSTRACT: Recently, a substantial increase in the prevalence of myopia was observed. Particularly high levels of myopia were found among children. Probably, it is caused by intensive near visual work such as: reading, writing, working on a computer. In this paper the definition and classification of myopia were described. The incidence, pathogenesis, management and new possibilities of treatment of this refractive error have been given. Special attention has been paid to the results of experimental and clinical studies of drugs inhibiting the progress of myopia.
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ABSTRACT: This study aims to investigate the relationship between corneal refractive power change along three axes (nasal, temporal, and inferior) after orthokeratology (OK) treatment and 2-year axial growth in children. Thirty-two Chinese children aged from 9 to 14 were fitted with OK. When corneal reshaping process following OK treatment was completed and stabilized, the 3-month topographic outputs were taken as the post-OK data. Corneal refractive powers along the nasal, temporal, and inferior axes were collected over an 8-mm-diameter ring in 1-mm steps using the sagittal power map. The maximum power change along each axis was selected and divided into two subcategories, level 1 and level 2, depending on whether the value was below or above the average. Axial length (AL) was measured every 6 months during a 24-month period. The relationship between the maximum power changes and 2-year axial elongation were analyzed. Twenty-seven subjects completed the 24-month study. After OK treatment, statistically significant steepening (p < 0.05) was observed at the nasal 2 mm and 3 mm; temporal 3 mm; and inferior 2 mm, 3 mm, and 4 mm locations compared with the apical center. AL increased significantly throughout the 24-month observation period (p < 0.001). Changes in corneal refractive power significantly affected axial elongation (nasal, p = 0.001; temporal, p = 0.011; inferior, p = 0.001). Two-year axial elongation in patients with larger corneal power changes (level 2) was reduced by 54% to 69% compared with those with smaller corneal power changes (level 1). Maximum power changes along the three axes were negatively correlated (p < 0.05) with 2-year axial growth. Subjects with larger magnitude of corneal relative peripheral power change along specific axes after OK treatment experienced slower axial elongation by the end of 24 months. This effect might be mediated by the induction of greater amount of relative myopic defocus on the peripheral retina. Our study lends weight to potential OK lens designs for myopia control in children.Optometry and vision science: official publication of the American Academy of Optometry 01/2014; DOI:10.1097/OPX.0000000000000183 · 2.04 Impact Factor
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ABSTRACT: Previous studies on soft multifocal contact lens myopia control published in the peer-reviewed literature reported findings of noncommercial contact lenses worn for 1 year or less. This study sought to determine the progression of myopia and axial elongation of children fitted with commercially available distance center soft multifocal contact lenses for 2 years. Eight- to eleven-year-old children with -1.00 D to -6.00 D spherical component and less than 1.00 D astigmatism were fitted with soft multifocal contact lenses with a +2.00 D add (Proclear Multifocal "D"; CooperVision, Fairport, NY). They were age- and gender-matched to participants from a previous study who were fitted with single-vision contact lenses (1 Day Acuvue; Vistakon, Jacksonville, FL). A-scan ultrasound and cycloplegic autorefraction were performed at baseline, after 1 year, and after 2 years. Multilevel modeling was used to compare the rate of change of myopia and axial length between single-vision and soft multifocal contact lens wearers. Forty participants were fitted with soft multifocal contact lenses, and 13 did not contribute complete data (5 contributed 1 year of data). The adjusted mean ± standard error spherical equivalent progression of myopia at 2 years was -1.03 ± 0.06 D for the single-vision contact lens wearers and -0.51 ± 0.06 for the soft multifocal contact lens wearers (p < 0.0001). The adjusted mean axial elongation was 0.41 ± 0.03 and 0.29 ± 0.03 for the single-vision and soft multifocal contact lens wearers, respectively (p < 0.0016). Soft multifocal contact lens wear resulted in a 50% reduction in the progression of myopia and a 29% reduction in axial elongation during the 2-year treatment period compared to a historical control group. Results from this and other investigations indicate a need for a long-term randomized clinical trial to investigate the potential for soft multifocal contact lens myopia control.Optometry and vision science: official publication of the American Academy of Optometry 09/2013; DOI:10.1097/OPX.0000000000000036 · 2.04 Impact Factor