Myopia control with novel central and peripheral plus contact lenses and extended depth of focus contact lenses: 2 year results from a randomised clinical trial (original) (raw)
Related papers
Journal of Optometry, 2009
Although previous studies suggest that orthokeratology contact lens wear slows eye growth in children with progressing myopia, some limitations in the methodology employed have become evident. Furthermore, the safety of this modality of visual correction has not been assessed. The study "Myopia Control with Orthokeratology Contact Lenses in Spain" (MCOS) is being conducted to compare axial length growth between white European myopic children wearing orthokeratology contact lenses (OK) and wearing distance single-vision spectacles (SV). Additionally, the incidence of adverse events and discontinuations is also recorded. We outline the methodology and baseline data adopted. METHODS: Subjects aged 6 to 12, with myopia ranging from 0.75 to 4.00 D and astigmatism ≤1.00 D were prospectively allocated OK or SV correction. Measurements of axial length, anterior chamber depth, corneal topography, cycloplegic autorefraction, visual acuity and corneal staining are performed at 6-month intervals. The incidence of adverse events and discontinuations are also recorded. RESULTS: Thirty one children were fitted with OK and 31 with SV correction. Eight subjects did not meet the refraction-related inclusion criteria for enrollment. No significant differences were found in baseline mean age and refractive and biometric data between the two groups (P>0.05). No adverse events were found in any of the two groups at baseline. CONCLUSION: To the authors' knowledge, MCOS is the first prospective clinical trial to assess the safety and efficacy of orthokeratology contact lens wear to slow myopia progression vs. single-vision spectacle wear. The MCOS offers a number of notable features: prospective design; well-matched samples and high-resolution ocular biometry measures, which should collectively elucidate whether orthokeratology contact lens wear is a feasible and safe method for myopia-progression control. (J Optom 2009;2:215-222
Efficacy and safety of a soft contact lens to control myopia progression
Clinical and Experimental Optometry, 2020
The control of myopia progression is currently considered an evidencebased therapeutic need. Background: To determine the efficacy and safety of the Esencia lens, a new soft contact lens (SCL) designed to slow down myopia progression in paediatric patients. Methods: This study was a randomised, parallel, double-masked clinical trial. Seventy myopic (−0.50 to −8.75 D) boys and girls, 7-15 years of age, were randomised and allocated to one of two groups: (i) study (n = 36) or (ii) control (n = 34). Study group patients were given the Esencia lens, a progressive multifocal and reverse geometry SCL. Control group patients were given conventional SCLs. Efficacy measurements (change in cycloplegic autorefraction and axial length) were measured at baseline and at the six-month intervals over a 12month period. Visual performance measurements were corneal power, comfort, quality of vision and contact lens fitting. Safety measures included detection of adverse events. Results: Mean changes in cycloplegic autorefraction after 12 months were −0.28 AE 0.35 D for study and −0.57 AE 0.52 D for control group patients (p = 0.02). A significantly lower increase in axial length was found in the study group (0.13 AE 0.12 mm) compared to control (0.22 AE 0.14 mm) patients (p = 0.03). Compared to control group patients, there was less myopia progression in the study group: 51 and 41 per cent in terms of cycloplegic autorefraction and axial length, respectively. No significant differences between groups for change in corneal power, comfort, vision quality and contact lens fitting were found (p > 0.05). Regarding safety, there were no serious and/or unexpected adverse events during the study. Conclusions: The Esencia lens seems to be efficacious in slowing down progression of myopia in children compared to traditional SCLs in the short term, with comparable safety features and visual outcomes.
A 3-year Randomized Clinical Trial of MiSight Lenses for Myopia Control
Optometry and Vision Science, 2019
SIGNIFICANCE Results of this randomized, double-masked clinical trial demonstrate the effectiveness of the MiSight soft contact lens in slowing myopia progression over multiple years. PURPOSE The purpose of this study was to quantify the effectiveness of MiSight daily disposable soft contact lens in slowing the progression of juvenile-onset myopia. METHODS Myopic children (spherical equivalent refraction, −0.75 to −4.00 D; astigmatism, <1.00 D) aged 8 to 12 years with no prior contact lens experience were enrolled in a 3-year, double-masked, randomized clinical trial at four investigational sites in four countries. Subjects in each group were matched for age, sex, and ethnicity and were randomized to either a MiSight 1-day contact lens (test) or Proclear 1-day (control; omafilcon A) and worn on a daily disposable basis. Primary outcome measures were the change in cycloplegic spherical equivalent refraction and axial length. RESULTS Of the subjects enrolled, 75.5% (109/144) comple...
A Clinical Study of the Impact of Soft Contact Lenses on the Progression of Myopia in Young Patients
Clinical Ophthalmology
To assess the impact of soft contact lenses on the progression of myopia in young patients. Patients and Methods: The observational study included 102 patients divided into 3 groups: MFCL (multifocal contact lenses) group: 15 girls and 9 boys, aged 8-20 (� x= 14.12 ± 2.863) with soft multifocal contact lenses with myopia: � x = −3.12 D ± 1.776 D and mean myopia progression −0.23 ± 0.233D after 2 years; SVCL (single vision contact lenses) group: 30 girls and 5 boys, 11-20 years old (� x=15.5 ± 2.24) with myopia � x = −2.88 ± 2.122 D at admission and mean myopia progression −0.54 ± 0.464 D after 2 years; the spectacle (single vision glasses) group: 25 girls and 18 boys, aged 8-18 years (� x = 13.65 ± 2.448) with single vision glasses with myopia: � x = −1.74 ± 1.412 D at admission and mean myopia progression −0.86 ± 0.489D after 2 years. Medical history and physical examination were performed every 6, 12, 18 and 24 months. Refractive error was examined using the autorefractometry after cycloplegia. Results: The analysis of myopia correction after 2 years showed differences between MFCL and spectacle correction. The change in myopia progression after 2 years was statistically significant for MFCL vs SVCL and MFCL vs spectacle correction when the myopia occured before the period of intensive growth. When myopia occurred during the period of intensive growth, difference was noted for MFCL vs spectacle correction and SVCL vs spectacle correction. When myopia occurred after a period of intensive growth, no significant differences between the groups were observed. Conclusion: 1) Multifocal contact lenses and some single vision contact lenses (Biofinity) may be useful in the control of myopia in younger patients, slowing the progression of nearsightedness; therefore, they can be a therapeutic option in inhibiting the progression of myopia. 2) The best effects of using multifocal contact lenses occur if myopia is diagnosed before the period of intensive growth.
Journal of Education, Health and Sport, 2021
Introduction and purpose. Early use of contact correction for congenital myopia and astigmatism in children and adolescents contributes to their social rehabilitation. The myopia correction with contact lenses provides sustainability of correction and absence of periods of blurred retinal images, which are experienced with the use of glasses. The purpose of the study was to determine, through long-term follow-up, the extent to which contact lens correction improves uncorrected and maximally corrected visual acuity in school-age children with myopia and myopic astigmatism. Material and methods. We followed up for three years 84 children (168 eyes) aged 6–16 years with myopic manifest refraction and astigmatism, who used soft silicone hydrogel aspherical contact lenses to correct ametropia. In the early and late follow-up, these patients were examined for visual acuity, objective and subjective clinical refraction, axial eye length, corneal thickness and diameter, keratometry, and pho...
Myopia Progression in Children Wearing Spectacles vs. Switching to Contact Lenses
Optometry and Vision Science, 2009
Purpose-To investigate myopia progression in Correction of Myopia Evaluation Trial (COMET) participants who switched to soft contact lenses (CLs) versus remained in spectacles after the clinical trial ended. Methods-469 ethnically diverse, 6-11 year old myopic children were randomly assigned to wear single vision lenses (SVLs) or progressive addition spectacle lenses (PALs) for 5 years as part of COMET. Afterwards they could choose another lens type, including CLs. Data in this paper are from 286 participants who wore their original spectacle lenses for 6 years (n =199) or wore CLs most or all of the time between the 5-and 6-year visits (n =87). Refractive error and axial length (AL) were measured after cycloplegia with 1% Tropicamide. The primary outcome was myopia progression between the 5-and 6-year visits. Two-year myopia progression was evaluated in a subset of 183 participants who wore the same lens type for an additional year. Myopia progression and AL were compared between the two lens groups using multiple linear regression. Results-Participants in the two groups were similar with respect to age, ethnicity, myopia at 5years, accommodation and phoria, but more girls switched to CLs than remained in spectacles (p<0.0001). Mean (± SD) myopia progression was higher (p=0.003) after one year in the CL group (−0.28 ± 0.33D) than the spectacle group (−0.14 ± 0.36D), and remained higher after two years in the 2-year subset (− 0.52 ± 0.46D versus −0.25 ± 0.39D, p<0.0001). Results were similar after adjustment for related factors. No significant differences in AL were found between groups after adjustment. Corneal curvature remained unchanged in both groups. Conclusions-COMET children switching from glasses to contact lenses experienced a small, statistically significant but clinically inconsequential increase in myopia progression.
One-year myopia control efficacy of spectacle lenses with aspherical lenslets
British Journal of Ophthalmology, 2021
AimsTo evaluate the 1-year efficacy of two new myopia control spectacle lenses with lenslets of different asphericity.MethodsOne hundred seventy schoolchildren aged 8–13 years with myopia of −0.75 D to −4.75 D were randomised to receive spectacle lenses with highly aspherical lenslets (HAL), spectacle lenses with slightly aspherical lenslets (SAL), or single-vision spectacle lenses (SVL). Cycloplegic autorefraction (spherical equivalent refraction (SER)), axial length (AL) and best-corrected visual acuity (BCVA) were measured at baseline and 6-month intervals. Adaptation and compliance questionnaires were administered during all visits.ResultsAfter 1 year, the mean changes in the SER (±SE) and AL (±SE) in the SVL group were −0.81±0.06 D and 0.36±0.02 mm. Compared with SVL, the myopia control efficacy measured using SER was 67% (difference of 0.53 D) for HAL and 41% (difference of 0.33 D) for SAL, and the efficacy measured using AL was 64% (difference of 0.23 mm) for HAL and 31% (dif...