scholarly journals Safety and efficacy of 0.02% and 0.01% atropine on controlling myopia progression: a 2-year clinical trial

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Can Cui ◽  
Xiujuan Li ◽  
Yong Lyu ◽  
Li Wei ◽  
Bingxin Zhao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Refractive Error ◽  
Pupil Diameter ◽  
Control Group ◽  
Spherical Equivalent ◽  
Myopia Progression ◽  
Safety And Efficacy ◽  
Single Vision ◽  
And Control ◽  
Myopia Control

AbstractFour hundred myopic children randomly received atropine 0.02% (n = 138) or 0.01% (n = 142) in both eyes once-nightly or only wore single-vision spectacles (control group) (n = 120) for 2 years. Spherical equivalent refractive error (SER), axial length (AL), pupil diameter (PD), and amplitude of accommodation (AMP) were measured every 4 months. After 2 years, the SER changes were − 0.80 (0.52) D, − 0.93 (0.59) D and − 1.33 (0.72) D and the AL changes were 0.62 (0.29) mm, 0.72 (0.31) mm and 0.88 (0.35) mm in the 0.02% and 0.01% atropine groups and control group, respectively. There were significant differences between changes in SER and AL in the three groups (all P < 0.001). The changes in SER and AL in the 2nd year were similar to the changes in the 1st year in the three groups (all P > 0.05). From baseline to 2 years, the overall decrease in AMP and increase in PD were not significantly different in the two atropine groups, whereas the AMP and PD in the control group remained stable (all P > 0.05). 0.02% atropine had a better effect on myopia control than 0.01% atropine, and its effects on PD and AMP were similar to 0.01% atropine. 0.02% or 0.01% atropine controlled myopia progression and AL elongation synchronously and had similar effects on myopia control each year.

scholarly journals Spectacle Lenses With Slightly Aspherical Lenslets for Myopia Control: Clinical Trial Design and Baseline Data

2021 ◽  
Author(s):  
Junhong Chen ◽  
Ran Zhuo ◽  
Jiayan Chen ◽  
Adeline Yang ◽  
Ee Woon Lim ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Visual Acuity ◽  
Refractive Error ◽  
Axial Length ◽  
Baseline Data ◽  
Major Public Health Problem ◽  
Spherical Equivalent ◽  
Single Vision ◽  
Significant Difference ◽  
Myopia Control

Abstract Objectives: Myopia is a major public health problem and it is essential to find safe and effective means to control its progression. The study design and baseline data are presented for a one-year prospective, double-masked, cross-over, randomized clinical trial evaluating the efficacy of single vision spectacle lenses with concentric rings of slightly aspherical contiguous lenslets technology (SAL) on myopia control. Methods: One hundred 8- to 13-year old Chinese children with a refractive error of -0.75 D to -4.75 D were assigned into two groups. In Group 1, SAL then single vision lenses were each worn for 6 months, and Group 2 wore the lenses in the reversed order. Primary outcomes are axial length and spherical equivalent of cycloplegic refractive error. Secondary outcomes include corneal thickness, anterior chamber depth, lens thickness, visual acuity, and lens adaptation.Results: No significant differences in baseline parameters (cycloplegic spherical equivalent, axial length, age) were found between groups (0.49 < p < 0.94). All children adapted well to the test lenses and there was no significant difference in visual acuity between the SAL and single vision lenses (p = 0.27).Conclusions: The children in the two well balanced groups had comparable visual acuity and adapted well to the test lenses. These results imply the visual acuity can be well improved by SAL lens. Clear visual acuity provide the assurance for good compliance in this longitudinal study.

Topical atropine in retarding myopia progression and axial length growth in children with myopia

2020 ◽  
Vol 13 (4) ◽  
pp. 111-114
Author(s):  
Abdur Rahman Mohammad Alam ◽  
Md. Sanwar Hossain ◽  
Md. Shafiqul Islam
Keyword(s):  
Axial Length ◽  
Control Group ◽  
Refractive Errors ◽  
Spherical Equivalent ◽  
Myopia Progression ◽  
Length Growth ◽  
Significant Difference ◽  
The Mean ◽  
And Control

This study was conducted to observe the effect of atropine in retarding myopia progression and axial length growth in 36 myopic children (atropine group, 24; control, 12). The initial spherical equivalent of the atropine group and control group was -3.0 ± 1.6 dioptre and -3.5 ± 1.6 dioptre respectively. At the 12th month in atropine group, it was -2.9 ± 2.6 dioptre and -4.6 ± 1.9 dioptre in the control group. The power of the atropine group reduced but rose in the control group after 12 months. There was a statistically significant difference in final refractive errors between the two groups (p<0.05). The initial axial length of the atropine group and control group was 24.3± 1.0 mm and 24.6 ± 1.1 mm respectively. In 12th month, the changes in axial length in the two groups was insignificant. However, the mean axial length progression at 12 months of the atropine group was -0.1 ± 0.1 mm and it was lower than the control group which was -0.2 ± 0.2 mm, and this was statistically significant (p<0.05). In conclusion, topical atropine (0.01%) retarded myopia progre-ssion and axial length growth in myopic children.    

scholarly journals Effect of low-dose atropine on myopia progression, pupil diameter and accommodative amplitude: low-dose atropine and myopia progression

2020 ◽  
pp. bjophthalmol-2019-315440 ◽  
Author(s):  
Aicun Fu ◽  
Fiona Stapleton ◽  
Li Wei ◽  
Weiqun Wang ◽  
Bingxin Zhao ◽  
...  
Keyword(s):  
Low Dose ◽  
Pupil Diameter ◽  
Repeated Measurements ◽  
Control Group ◽  
Eye Drops ◽  
Control Groups ◽  
Myopia Progression ◽  
Registration Number ◽  
And Control ◽  
Accommodative Amplitude

PurposeTo evaluate the effects of 0.01% and 0.02% atropine eye drops on myopia progression, pupil diameter and accommodative amplitude in myopic children.MethodsA cohort study assessed 400 myopic children divided into three groups: 138 and 142 children were randomised to use either 0.02% or 0.01% atropine eye drops, respectively. They wore single-vision (SV) spectacles, with one drop of atropine eye drop applied to both eyes once nightly. Control children (n=120) only wore SV spectacles. Repeated measurements of spherical equivalent refractive errors (SERs), axial length (AL), pupil diameter and accommodative amplitude were performed at baseline, and 4, 8 and 12 months after treatment.ResultsAfter 12 months, the SER change was −0.38±0.35D, −0.47±0.45D, −0.70±0.60D and AL change was 0.30±0.21 mm, 0.37±0.22 mm, 0.46±0.35 mm in the 0.02%, 0.01% atropine and control groups, respectively. There were significant differences in the change in AL and SER between three groups (all p<0.001). Between baseline and the 12-month visit, the overall change in accommodative amplitude was 1.50±0.25D, 1.61±0.31D and change in pupil diameter was 0.78±0.42 mm, 0.69±0.39 mm, with 0.02% and 0.01% atropine, respectively. Accommodative amplitude significantly decreased and pupil diameter significantly increased in two atropine groups (all p<0.001). Moreover, there was no statistical difference in the change difference in accommodative amplitude and pupil diameter between two atropine groups (p=0.24, p=0.38), whereas the accommodative amplitude (p=0.45) and pupil diameter (p=0.39) in the control group remained stable.Conclusions0.02% atropine eye drops had a better effect on myopia progression than 0.01% atropine, but 0.02% and 0.01% atropine showed similar effects on pupil diameter and accommodative amplitude after 12 months of treatment.Trial registration numberChiCTR-IPD-16008844.

scholarly journals To Correct or Not Correct? Actual Evidence, Controversy and the Questions That Remain Open

2020 ◽  
Vol 9 (6) ◽  
pp. 1975
Author(s):  
Miguel García García ◽  
Katharina Breher ◽  
Arne Ohlendorf ◽  
Siegfried Wahl
Keyword(s):  
Basic Research ◽  
Control Group ◽  
Myopia Progression ◽  
Ethical Implications ◽  
Eye Growth ◽  
Single Vision ◽  
Full Correction ◽  
New Guidelines ◽  
Lens Wear ◽  
Myopia Control

Clinical studies and basic research have attempted to establish a relationship between myopia progression and single vision spectacle wear, albeit with unclear results. Single vision spectacle lenses are continuously used as the control group in myopia control trials. Hence, it is a matter of high relevance to investigate further whether they yield any shift on the refractive state, which could have been masked by being used as a control. In this review, eye development in relation to eyes fully corrected versus those under-corrected is discussed, and new guidelines are provided for the analysis of structural eye changes due to optical treatments. These guidelines are tested and optimised, while ethical implications are revisited. This newly described methodology can be translated to larger clinical trials, finally exerting the real effect of full correction via single vision spectacle lens wear on eye growth and myopia progression.

scholarly journals Ocular and corneal aberrations changes in controlled randomized clinical trial MiSight® Assessment Study Spain (MASS)

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Daniela Lopes-Ferreira ◽  
Alicia Ruiz-Pomeda ◽  
Belén Peréz-Sanchéz ◽  
António Queirós ◽  
César Villa-Collar
Keyword(s):  
Clinical Trial ◽  
Contact Lenses ◽  
Spherical Aberration ◽  
High Order ◽  
Control Group ◽  
Myopia Progression ◽  
Corneal Aberrations ◽  
Single Vision ◽  
Control Versus ◽  
Low Order

Abstract Background To compare ocular and corneal inherent aberrations in the naked eyes of randomly selected children fitted with MiSight contact lenses (CL) for myopia control, versus children corrected with single-vision spectacles (control), over a 24-months period. Methods Children aged 8 to 12 years, with myopia (-0.75 to -4.00 D sphere) and astigmatism (< -1.00 D cylinder) were randomly assigned to the lens study group (MiSight) or the control group (single-vision spectacles). The root mean square aberration (RMS) was determined as corneal (RMS_C), corneal high order RMS (HO_RMS_C), corneal low order RMS (LO_RMS_C), ocular (total) RMS (RMS_T), ocular high order RMS (HO_RMS_T), ocular low order RMS (LO_RMS_T), corneal spherical aberration (SA_C) and ocular SA (SA_T) were calculated by aberrometry measures at the baseline, on 12-months and 24-months visits. A 5 mm diameter was defined for the analysis in all visits for all subjects. Only the dominant eye was analyzed. Results Seventy-four subjects completed the clinical trial: 41 subjects from the MiSight group (age: 11.01 ± 1.23 years) and 33 from the single-vision group (age: 10.12 ± 1.38 years). RMS_T significantly changed (0.57 ± 0.20 µm, p = 0.029) after 24-months in the control group. In the MiSight group no significant changes were registered (p > 0.05). The SA_C and SA_T did not reveal significant changes between visits or between groups (p > 0.05). Conclusions Along 2 years, MiSight CL did not induce significant changes in RMS of anterior cornea or total ocular RMS. Contrary, in control group the RMS_T significantly changed as response of greater eye growth and myopia progression. The results obtained in present study allow to predict corneal or total aberration changes, in children, in response of wearing of MiSight lens along the time. Trial registration : ClinicalTrials.gov Identifier: NCT01917110.

scholarly journals Ocular and Corneal Aberrations changes in controlled randomized clinical trial MiSight® Assessment Study Spain (MASS)

2020 ◽  
Author(s):  
DANIELA LOPES-FERREIRA ◽  
Alicia Ruiz-Pomeda ◽  
Belén Peréz-Sanchéz ◽  
António Queirós ◽  
César Villa-Collar
Keyword(s):  
Clinical Trial ◽  
Axial Length ◽  
Contact Lenses ◽  
Spherical Aberration ◽  
High Order ◽  
Control Group ◽  
Myopia Progression ◽  
Corneal Aberrations ◽  
Single Vision ◽  
Low Order

Abstract BackgroundTo compare ocular and corneal inherent aberrations in the naked eyes of randomly selected children fitted with MiSight contact lenses (CL) for myopia control, versus children corrected with single-vision spectacles (control), over a 24-months period.MethodsChildren aged 8 to 12 years, with myopia (-0.75 to -4.00 D sphere) and astigmatism (< -1.00 D cylinder), were assigned to the lens study group (MiSight) or the control group (single-vision spectacles). Axial length (AL) was measured by biometry, corneal RMS (RMS_C), corneal high order RMS (HO_RMS_C), corneal low order RMS (LO_RMS_C), ocular total RMS (RMS_T), ocular total high order RMS (HO_RMS_T), ocular total low order RMS (LO_RMS_T), corneal spherical aberration (SA_C) and ocular total SA (SA_T) were calculated by aberrometric measures at the baseline, and on 12- and 24-months visits. A 5 mm diameter was defined for the analysis in all visits for all subjects. Only the dominant eye was analyzed.ResultsSeventy-four subjects completed the clinical trial: 41 subjects from the MiSight group (age: 11.01 ± 1.23 years) and 33 from the single-vision group (age: 10.12 ± 1.38 years). In the control group, axial length changed significantly (0.444 ± 0.049 mm, p < 0.001) after 2 years. Also RMS_T (0.565 ± 0.199 µm, p = 0.029) and LO_RMS_T (0.461 ± 0.175 µm, p = 0.047) registered significant changes after 24-months in the control group. In the MiSight group, only axial length changed significantly (0.284 ± 0.025 mm, p < 0.001) after 2 years. The SA_C and SA_T did not reveal significant changes between visits or between groups.ConclusionsThe wear of MiSight CL did not induce significant changes in aberrations in anterior cornea and contrary of control group the total ocular RMS and low order RMS did not significantly caused by significantly lower eye growth and myopia progression,Trial registration: ClinicalTrials.gov Identifier: NCT01917110.

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

2015 ◽  
Vol 2015 ◽  
pp. 1-10 ◽  
Author(s):  
Jaime Pauné ◽  
Hari Morales ◽  
Jesús Armengol ◽  
Lluisa Quevedo ◽  
Miguel Faria-Ribeiro ◽  
...  
Keyword(s):  
Contact Lenses ◽  
Study Groups ◽  
Control Group ◽  
Myopia Progression ◽  
Axial Elongation ◽  
Children And Adolescent ◽  
Single Vision ◽  
The Mean ◽  
Prospective Longitudinal ◽  
Myopia Control

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.

scholarly journals A 3-year Randomized Clinical Trial of MiSight Lenses for Slowing Myopia Progression

The Eye ◽  
2020 ◽  
Vol 22 (4(132)) ◽  
pp. 11-28
Author(s):  
P. Chamberlain ◽  
Sofia C. Peixoto-de-Matos ◽  
N. S. Logan ◽  
Ch. Ngo ◽  
D. Jones ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Contact Lens ◽  
Axial Length ◽  
Test Group ◽  
Control Group ◽  
Spherical Equivalent ◽  
Soft Contact ◽  
Myopia Progression ◽  
Soft Contact Lens ◽  
Spherical Equivalent Refraction

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) completed the clinical trial (53 test, 56 control). Unadjusted change in spherical equivalent refraction was −0.73 D (59%) less in the test group than in the control group (−0.51 ± 0.64 vs. –1.24 ± 0.61 D, P < 0.001). Mean change in axial length was 0.32 mm (52%) less in the test group than in the control group (0.30 ± 0.27 vs. 0.62 ± 0.30 mm, P < 0.001). Changes in spherical equivalent refraction and axial length were highly correlated (r = −0.90, P < .001). Over the course of the study, there were no cases of serious ocular adverse events reported. Four asymptomatic corneal infiltrative (one test, three control) events were observed at scheduled study visits.Conclusions. Results of this clinical trial demonstrate the effectiveness of the MiSight daily disposable soft contact lens in slowing change in spherical equivalent refraction and axial length.

scholarly journals Atropine 0.01% for the Control of Myopia in Chinese Children: Effect on Accommodation Functions and Pupil Size

2020 ◽  
Vol 2020 ◽  
pp. 1-8
Author(s):  
Yuliang Wang ◽  
Jing Yao ◽  
Xiaomei Qu
Keyword(s):  
Pupil Size ◽  
Pupil Diameter ◽  
Chinese Children ◽  
Secondary Outcome ◽  
Control Group ◽  
Eye Drops ◽  
Myopia Progression ◽  
Single Vision ◽  
To Receive

Background. To explore the effect of atropine 0.01% on accommodation functions and pupil size for safely and effectively controlling myopia in Chinese children. Methods. This was a single-center randomized clinical trial. 63 participants with myopia of at least −0.50 D and astigmatism of ≤−2.50 D were enrolled and randomized to receive atropine 0.01% once nightly with regular single-vision lenses or to wear regular single-vision lenses, in an allocation ratio of 3 : 2. Primary outcomes included changes of accommodation functions, pupil diameter, distant and near best-corrected visual acuity (BCVA), near stereoacuity, and intraocular pressure (IOP). Secondary outcome was myopic progression at 6 months. Results. 61 participants completed the follow-up. Compared with the control group, the atropine-treated children showed a statistically significant increase in pupil diameter after 6 months (0.7 ± 0.7 vs. 0.1 ± 0.5 mm, P=0.01). Despite the enlarged pupil, routine vision-related activities were not affected. The mean changes in accommodative functions, BCVA, near stereoacuity, and IOP, did not differ significantly between the groups. At 6 months, participants in the control group showed greater myopia progression than those in the atropine group (spherical equivalent: −0.60 ± 0.43 vs.−0.30 ± 0.42 D, P<0.001; axial length: 0.35 ± 0.20 vs. 0.24 ± 0.16 mm, P=0.001). Conclusions. Atropine 0.01% eye drops significantly increased pupil diameter less than one mm, but it did not affect accommodative functions, BCVA, near stereoacuity, and IOP. Combined with its reducing myopia progression, atropine 0.01% can be used as a safe and effective treatment for myopia in Chinese children.

scholarly journals Ocular and Corneal Aberrations changes in controlled randomized clinical trial MiSight® Assessment Study Spain (MASS)

2020 ◽  
Author(s):  
Daniela Lopes-Ferreira ◽  
Alicia Ruiz-Pomeda ◽  
Belén Peréz-Sanchéz ◽  
António Queirós ◽  
César Villa-Collar
Keyword(s):  
Clinical Trial ◽  
Contact Lenses ◽  
Spherical Aberration ◽  
High Order ◽  
Control Group ◽  
Myopia Progression ◽  
Corneal Aberrations ◽  
Single Vision ◽  
Control Versus ◽  
Low Order

Abstract Background: To compare ocular and corneal inherent aberrations in the naked eyes of randomly selected children fitted with MiSight contact lenses (CL) for myopia control, versus children corrected with single-vision spectacles (control), over a 24-months period. Methods: Children aged 8 to 12 years, with myopia (-0.75 to -4.00 D sphere) and astigmatism (< -1.00 D cylinder), were assigned to the lens study group (MiSight) or the control group (single-vision spectacles). Axial length (AL) was measured by biometry, the root mean square aberration (RMS) was determined as corneal (RMS_C), corneal high order RMS (HO_RMS_C), corneal low order RMS (LO_RMS_C), ocular total RMS (RMS_T), ocular total high order RMS (HO_RMS_T), ocular total low order RMS (LO_RMS_T), corneal spherical aberration (SA_C) and ocular total SA (SA_T) were calculated by aberrometric measures at the baseline, and on 12- and 24-months visits. A 5 mm diameter was defined for the analysis in all visits for all subjects. Only the dominant eye was analyzed. Results: Seventy-four subjects completed the clinical trial: 41 subjects from the MiSight group (age: 11.01 ± 1.23 years) and 33 from the single-vision group (age: 10.12 ± 1.38 years). In the control group, RMS_T (0.57 ± 0.20 µm, p = 0.029) and LO_RMS_T (0.46 ± 0.18 µm, p = 0.047) registered significant changes after 24-months in the control group. In the MiSight group no significant changes were registered. The SA_C and SA_T did not reveal significant changes between visits or between groups. Conclusions: The wear of MiSight CL did not induce significant changes in aberrations in anterior cornea and contrary of control group the total ocular RMS and low order RMS did not significantly caused by significantly lower eye growth and myopia progression. The naked eye results obtained in present study allow to predict that children do not develop basal corneal or total aberration changes in response of wearing MiSight lens along the time.Trial registration: ClinicalTrials.gov Identifier: NCT01917110.

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