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To evaluate the efficacy of a myopia control spectacle lens (DIMS) at slowing the progression of myopia in a population of European children in comparison with 0.01% atropine and combined DIMS and atropine. The study was a non-randomised experimenter-masked prospective controlled observational study of individuals aged 6-18 years with progressing myopia but no ocular pathology. Participants were allocated, according to patient/parent choice, to receive 0.01% atropine eyedrops, DIMS (Hoya® MiyoSmart®) spectacles, combined atropine+DIMS or single vision spectacle lenses (control group). The key outcome variables, cycloplegic autorefraction spherical equivalent refraction (SER) and axial length (AL), were measured at baseline and after three, six, and 12 months. Of the 146 participants (mean age 10.3y ±3.2), 53 received atropine, 30 DIMS spectacles, 31 atropine+DIMS, and 32 single vision control spectacles. Generalized linear mixed model analysis revealed for SER, whilst controlling for age and SER at baseline, at each stage all treatment groups had significantly reduced progression compared with the control group (p<0.016). For AL, whilst controlling for baseline age and AL, at 6 and 12 months all treatment groups had significantly less progression than the control group (p<0.005). For SER only, in pairwise comparisons at 12 months the atropine+DIMS group had significantly reduced progression compared with the DIMS only and Atropine only groups (p<0.001). In a European population, DIMS and atropine are effective at reducing myopia progression and axial elongation in progressing myopia and are most successful at reducing myopia progression when used in combination.

AimsTo evaluate the efficacy and safety of 0.01% atropine eye-drops in controlling myopia progression over 5 years.MethodsExperimental, analytical, prospective, randomised and longitudinal study, in 361 right eyes from 361 children randomised into the control group (177 eyes without treatment) and treatment group (184 eyes with 0.01% atropine eye-drops). Children assigned to the treatment group used 0.01% atropine once a day every night and the control group’s children did not use any treatment or placebo. All the subjects completed an eye examination every 6 months for the 5 years of follow-up. The examination included subjective and objective refraction with cycloplegia, axial length (AL), keratometry and anterior chamber depth (ACD) to evaluate the efficacy of the treatment. It also included the anterior and posterior pole examination to evaluate the safety of the treatment.ResultsThe SE increased −0.63±0.42D in children after 5 years of treatment with 0.01% atropine, while in the control group the increase was −0.92±0.56D. AL increased 0.26±0.28 mm in the treatment group compared with 0.49±0.34 mm in the control group. Atropine 0.01% showed an efficacy of 31.5% and 46.9% in the control of the SE and AL increase, respectively. ACD and keratometry did not have significant changes between groups.ConclusionsAtropine 0.01% is effective in slowing myopia progression in a European population. There were no side effects after 5 years of 0.01% atropine.

Atropine eye drops and myopic retinal defocus each slow progression of myopia (short-sight). They also cause thickening of the choroid, and it has been suggested that the thickening is a precursor for reduced eye growth and slowed myopia progression. We investigated whether choroidal thickening due to optical defocus would add to thickening due to atropine when both were applied simultaneously. Addition would suggest that combining the two clinical treatments may improve efficacy of myopia control. We studied 20 children receiving 0.3% atropine daily for myopia control, over a period of 6 months. We imposed short periods of retinal defocus (1 h of myopic or hyperopic defocus (± 2.00D)) both before, and after 1 week and 3 and 6 months of atropine treatment. Prior to atropine, myopic or hyperopic defocus caused significantly thicker or thinner choroids respectively (± 12 µm, p < 0.001). After one week of atropine alone, thickness had increased (+ 21 µm; SD 17 µm; p < 0.001), and it increased further (by + 13 µm; SD 6 µm; p < 0.001) when exposed to myopic defocus. Atropine abolished choroidal thinning in response to hyperopic defocus. These effects remained the same after 3 and 6 months of atropine treatment. Our results show that additive effects of atropine and optical defocus are present at the level of the choroid, and suggest that combining optical and pharmaceutical treatments is likely to enhance efficacy of clinical myopia control.

Myopia has been a rising problem globally. Early-onset myopia significantly increases the risk of high myopia later in life. Despite the proven benefits of increased outdoor time, optimal strategies for preventing early-onset myopia in premyopic children need further investigation. This randomized controlled trial aims to evaluate the efficacy of optical (Defocus Incorporated Multiple Segments [DIMS] spectacle lenses) and pharmacological (0.01% atropine eye drops) interventions in preventing myopia among premyopic preschoolers. We will recruit 234 premyopic, asymptomatic 5-to-6-year-old children who will have received cycloplegic autorefraction examination in a countywide kindergarten eye care program in Yilan County, Taiwan. Eligible participants will be randomly assigned to DIMS spectacles (n = 78), 0.01% atropine (n = 78), or usual care (n = 78). In the DIMS group, preschoolers will be instructed to wear spectacles at home before entering elementary school but to wear them all the time after school entry. In the atropine group, subjects will be given 0.01% atropine eyedrops nightly throughout the study period. All participants will be encouraged to spend time outdoors for 2 hours every day. During the 18-month study period, cycloplegic spherical equivalent (SE) refraction, axial length, and subfoveal choroidal thickness will be measured every three months, and parents-administered questionnaires regarding risk factors for myopia will be performed every nine months. The change in mean cycloplegic SE. The cumulative percentage of incident myopia, the cumulative percentage of a fast myopic shift of SE, and the changes in mean axial length. The time to myopia onset, alteration in subfoveal choroidal thickness, and levels of near work/outdoor activities. This study is registered at www.clinicaltrials.gov as NCT06200194. This trial will provide insights into myopia prevention strategies and inform new eye care policies for early identification and intervention in premyopic preschoolers.

Background: To evaluate the additive effects of orthokeratology (OK) lenses and 0.01% atropine on slowing axial elongation in myopic children. Methods: A prospective, randomized, double-blinded, placebo-controlled trial was conducted over a 12-month period. Sixty children aged 8 to 12 years with spherical equivalent refraction from − 1.00 to -4.00 D who had been wearing OK lenses successfully for 2 months (as baseline) were randomly assigned in a 1:1 ratio to combination group (combination of OK lens and 0.01% atropine eye drops) and control group (combination of OK lens and placebo). The primary outcome was change in axial length, along with secondary outcomes including change in pupil diameter (PD) and accommodative amplitude (AMP) at 12 months (measured at 4-month intervals). Results: After 12 months, the overall axial elongation was 0.10 ± 0.14 mm and 0.20 ± 0.15 mm (p = 0.01) in the combination and control groups, respectively. The change in axial length in the two groups showed significant differences only in the first four months (median [Q1, Q3] (95% CI), -0.01 mm [-0.07, 0.05] (-0.06, 0.04) vs. 0.04 mm [0.00, 0.10] (0.02, 0.09); p = 0.04), but no difference thereafter. Multivariate linear regression analysis showed that the axial elongation was significantly slower in the combination group than in the control group (standard β = -0.10, p = 0.02). PD significantly increased by 0.45 mm [0.20, 0.68] at the 4th month visit (p < 0.001) and then remained stable in the combination group. The PD in the control group and AMP in the two groups remained stable from baseline to 12 months (all p > 0.05). Conclusion: The combination therapy was more effective than the OK lens alone in slowing axial elongation after 12 months of treatment, and mainly in the first 4 months. Trial registration: The First Affiliated Hospital of Zhengzhou University, ChiCTR2000033904. Registered 16/06/2020, http://www.chictr.org.cn/login.aspx?referurl=%2flistbycreater.aspx

Side effects are frequent in pharmacological pain management, potentially preceding analgesia and limiting drug tolerability. Discussing side effects is part of informed consent, yet can favor nocebo effects. This study aimed to test whether a positive suggestion regarding side effects, which could act as reminders of the medication having been absorbed, might favor analgesia in a clinical interaction model. Sixty-six healthy males participated in a study \"to validate pupillometry as an objective measure of analgesia\". Participants were unknowingly randomized double-blind to positive vs control information about side effects embedded in a video regarding the study drugs. Sequences of moderately painful heat stimuli applied before and after treatment with diclofenac and atropine served to evaluate analgesia. Atropine was deceptively presented as a co-analgesic, but used to induce side effects. Adverse events (AE) were collected with the General Assessment of Side Effects (GASE) questionnaire prior to the second induced pain sequence. Debriefing fully informed participants regarding the purpose of the study and showed them the two videos.The combination of medication led to significant analgesia, without a between-group difference. Positive information about side effects increased the attribution of AE to the treatment compared to the control information. The total GASE score was correlated with analgesia, i.e., the more AEs reported, the stronger the analgesia. Interestingly, there was a significant between-groups difference on this correlation: the GASE score and analgesia correlated only in the positive information group. This provides evidence for a selective link between AEs and pain relief in the group who received the suggestion that AEs could be taken as a sign \"that help was on the way\". During debriefing, 65% of participants said they would prefer to receive the positive message in a clinical context. Although the present results cannot be translated immediately to clinical pain conditions, they do indicate the importance of testing this type of modulation in a clinical context.

IntroductionMyopia is a major cause of degenerative eye disease and increases the risk of secondary visual impairment. Mitigating its progression therefore has great potential of clinically relevant benefit as shown by using highly diluted atropine eye drops in children of Asian origin. However, limited evidence is available regarding the efficacy and safety of low-dose atropine therapy in non-Asian populations. Hence, the Low-dose AtropIne for Myopia Control in Children (AIM) study will test the efficacy and safety of 0.02% atropine vs placebo in a German population.Methods and analysisAIM is a national, multicentre, prospective, randomised, placebo-controlled, double-blind trial with two parallel arms. The primary objective is to assess the efficacy of atropine 0.02% eyedrops for myopia control in children of Caucasian origin. The primary outcome is the change in cycloplegic refraction after 1 year of treatment (D/year). Secondary and tertiary outcome measures comprise the change in axial length (mm/year) in children treated with 0.02% atropine compared with placebo, the myopic progression of participants treated with 0.01% compared with 0.02% atropine (D/year and mm/year), and the safety profile of both 0.02% and 0.01% atropine. Furthermore, the myopic progression 1 year after cessation of therapy with 0.02% atropine will be evaluated. Inclusion criteria are an age of 8–12 years and myopia of −1 D to −6 D with an estimated annual myopia progression of ≥0.5 D. After randomisation, patients will receive either atropine 0.02% (arm A) or placebo eye drops (arm B) in the first year of treatment. In the second year, they will continue to receive atropine 0.02% (arm A) or switch to atropine 0.01% (arm B). In the third year, they will switch to placebo (arm A) or continue with atropine 0.01% (arm B). To achieve a statistical power of 80%, the calculated sample size is 300. The trial has started in October 2021 with a planned recruitment period of 18 months.Ethics and disseminationAIM has been approved by the Central Ethics Committee of the University Medical Center Freiburg (21-1106), local ethics committees of each participating centre and the German Federal Institute for Drugs and Medical Devices (61-3910-4044659). It complies with the Declaration of Helsinki, local laws and ICH-GCP. Results and underlying data from this trial will be disseminated through peer-reviewed publications and conference presentations.Trial registration numberNCT03865160.

Objectives To investigate the effect of bifocal wearing in the amblyopic eye when atropine is used in the sound eye for the treatment of hyperopic anisometropic amblyopia. Methods Children 4–8 years old were randomly assigned to bifocal + atropine ( n  = 16) or only atropine (control, n  = 19) groups of treatment in a proof-of-concept study. Measurements included visual acuity (logMAR), prism and cover test, stereoacuity (Randot preschool or Randot circles), contrast sensitivity (MARS test), accommodation (Grand Seiko WAM5500 and dynamic retinoscopy), retinoscopic and subjective refraction, before starting treatment and at 6 months, except accommodation, which was remeasured at 9–11 months. Main outcome measure was change in logMAR lines of visual acuity, and secondary outcome measures were change in stereoacuity and contrast sensitivity in the amblyopic eye, at 6 months. Results Improvement in visual acuity of the amblyopic eye was significantly better ( p  = 0.04) in the atropine plus bifocal (3.3 ± 0.9 logMAR lines) than in the atropine only group (2.6 ± 0.8 logMAR lines), whereas change in stereoacuity and contrast sensitivity was not significantly different between the two groups. Differences in accommodative gain, which was impaired in the amblyopic compared to the sound eye, before treatment, decreased after treatment, in the atropine group (0.62 ± 0.16 vs 0.79 ± 0.2, p  = 0.3), and atropine + bifocal group (0.69 ± 0.15 vs 0.82 ± 0.2, p  = 0.4). Conclusions Use of bifocal lens add in the amblyopic eye of children with hyperopic anisometropic amblyopia, treated by atropine penalization, is beneficial in the follow-up period of 6 months.

IntroductionAssessment of near work-induced transient myopia (NITM) is important for permanent myopia development and progression. Atropine eye drop has been reported to be beneficial in reducing initial NITM and slowing down myopic progression. This study aimed to investigate the efficacy of 0.01% atropine in treating NITM and its possible association with the progression of refractive change in Chinese myopic children.Methods and analysisThe study is designed as a parallel assignment prospective, randomised, double-blinded, placebo-controlled trial conducted at He Eye Specialist Hospital in Shenyang, China. One hundred fifty participants will be randomly assigned in a 1:1 ratio to receive 0.01% atropine or placebo eye drop once nightly bilaterally for 1 year. Initial NITM, cycloplegic refraction, axial length, best-corrected visual acuity, intraocular pressure and pupil diameter will be measured at baseline, 4 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks. Visual Function Questionnaire will be administered at baseline and each follow-up visit. Adverse events also will be monitored and documented at each subsequent follow-up visit.Ethics and disseminationA parallel assignment prospective, randomised, double-blinded, placebo-controlled trial to evaluate the efficacy of 0.01% atropine for near work-induced transient myopia and myopic progression registered on 10 September 2023. Ethics approval number: IRB (2023) K025.01. The study’s findings will be shared regardless of the effect’s direction.Trial registration numberNCT06034366.

Background To evaluate the effects of 0.02% and 0.01% atropine eye drops on ocular and corneal astigmatism over 2 years. Methods A prospective clinic-controlled trail. The cohort study assessed 400 myopic children and divided them into three groups: 138 and 142 children were randomized to use either 0.02% or 0.01% atropine eye drops, respectively. They wore single-vision (SV) spectacles, with one drop of atropine applied to both eyes once nightly. Control children ( n  = 120) only wore SV spectacles. Spherical equivalent refractive errors (SER) and corneal curvature were measured every 4 months. The SER and corneal curvature were assessed by cycloplegic autorefraction and IOLMaster. Ocular and corneal astigmatism were calculated by Thibos vector analysis and then split into its power vector components, J0 (with-the-rule astigmatism) and J45 (oblique). Results After 2 years, the ocular astigmatism increased by -0.38 ± 0.29 D, -0.47 ± 0.38 D, -0.41 ± 0.35 D in the 0.02%, 0.01% atropine groups and control group, respectively ( p  = 0.15). The corresponding corneal astigmatism increased by -0.20 ± 0.34 D, -0.28 ± 0.35 D and -0.26 ± 0.26 D ( p  = 0.18). The ocular astigmatism J0 increased by 0.19 ± 0.28 D, 0.22 ± 0.36 D, 0.18 ± 0.31 D in the 0.02% atropine, 0.01% atropine and control groups, respectively ( p  = 0.65). The corresponding corneal astigmatism J0 increased by -0.05 ± 0.34 D, -0.11 ± 0.37 D and -0.13 ± 0.30 D ( p  = 0.23). There was a small but significant increase in ocular astigmatism (including J0) (all P  < 0.05), but there were no changes in the ocular astigmatism J45 and corneal astigmatism (including J0 and J45) in the three groups over time (all p  > 0.05). However, there were no significant differences in the changes in ocular astigmatism (including J0) among the three groups. Conclusions Treatment with 0.02% and 0.01% atropine had no clinically significant effect on ocular and corneal astigmatism over 2 years. Trial registration The First Affiliated Hospital of Zhengzhou University, ChiCTR-IPD-16008844 . Registered 14/07/2016.