Trial Summary
What is the purpose of this trial?This trial is testing eye drops and special glasses or contact lenses to see if they can slow down worsening nearsightedness in children by controlling eye growth and changing how light enters the eye.
Is the drug Atropine with MiSight contact lenses a promising treatment for near-sightedness?Yes, combining the drug Atropine with MiSight contact lenses is promising for treating near-sightedness. Studies show that this combination can significantly slow down the progression of myopia in children, making it an effective option.23458
What safety data exists for Atropine and MiSight contact lenses in treating near-sightedness?The safety of Atropine and MiSight contact lenses has been evaluated in several studies. A case series combining 0.05% atropine with MiSight contact lenses in children showed no adverse reactions over a year, with regular evaluations confirming safety. The LAMP study assessed low-concentration atropine (0.05%, 0.025%, and 0.01%) and found it to be safe over a 1-year period. The MOSAIC trial is investigating the safety of 0.01% atropine in a European population, with safety as a secondary outcome measure. These studies suggest that low-concentration atropine and MiSight lenses are generally safe for controlling myopia progression.15678
What data supports the idea that Atropine vs MiSight Contact Lenses for Near-Sightedness is an effective treatment?The available research shows that using a combination of 0.05% atropine eye drops and MiSight contact lenses can effectively slow down the progression of near-sightedness in children. In a study involving four children, their myopia progression decreased significantly from -1.45 to -0.41 over one year. Additionally, the study found that the increase in eye length, which is linked to worsening near-sightedness, was also reduced. This suggests that the combination of atropine and MiSight lenses is effective in managing near-sightedness. Other studies have shown that low-concentration atropine alone can also help control myopia progression, with 0.05% atropine being more effective than lower concentrations.368910
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, if you are using any form of myopia control, bifocal, progressive-addition lenses, or multifocal contact lenses, you cannot participate. Also, if you have conditions requiring regular medication that might interact with the study, you may be excluded.
Eligibility Criteria
This trial is for children aged 5-12 with mild to high near-sightedness, weighing over 1500g at birth and born after at least 32 weeks of gestation. It excludes those with certain eye abnormalities, previous myopia treatments, systemic conditions affecting the eyes, or a history of eye surgeries.Treatment Details
The study compares two methods to control myopia in kids: Atropine drops versus MiSight contact lenses. The goal is to understand how these treatments affect the development and progression of near-sightedness in young eyes.
3Treatment groups
Experimental Treatment
Active Control
Group I: MiSight contact lensesExperimental Treatment1 Intervention
MiSight contact lenses. Daily wear for 2 years.
Group II: AtropineExperimental Treatment1 Intervention
0.05% atropine. One drop per eye per day for 2 years.
Group III: ObservationActive Control1 Intervention
No treatment.
Atropine is already approved in United States, Canada for the following indications:
🇺🇸 Approved in United States as Atropine for:
- Uveitis
- Pupillary dilation
- Refraction assessment
- Amblyopia
- Cycloplegia
🇨🇦 Approved in Canada as Atropine for:
- Uveitis
- Pupillary dilation
- Refraction assessment
- Amblyopia
- Cycloplegia
Find a clinic near you
Research locations nearbySelect from list below to view details:
Ann & Robert H. Lurie Children's Hospital of ChicagoChicago, IL
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Who is running the clinical trial?
Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor
References
[Prolonged mydriasis caused by Lamaline]. [2013]Atropine derivatives. The presence of atropine derivatives in numerous combined medicines is often ignored or reflected. A case report of prolonged bilateral non reactive mydriasis with "cycloplegia", linked with the utilisation of a therapeutic dose of Lameline suppositories raises the question of individual susceptibility, with particular ocular sensitivity. This urge one not to ignore the presence of these products and to respect the contraindications, even with minute doses.
Status of cyclopentolate as a cycloplegic in children: a comparison with atropine and homatropine. [2019]We compared the cycloplegic effects of cyclopentolate, homatropine and atropine by the retinoscopy findings and residual accommodation left following their use in the same individual. The mean residual accommodation measured after the use of cyclopentolate, homatropine and atropine was 1.48 +/- 0.33 D, 2.32 +/- 0.37 D and 1.10 D +/- 0.28 D, respectively, and the mean difference in retinoscopy readings between cyclopentolate and homatropine, homatropine and atropine, and atropine and cyclopentolate was 0.46 +/- 0.21, 0.71 +/- 0.23 and 0.26 +/- 0.14, respectively. We further observed that a tonus allowance of about +0.75 D would suffice for cyclopentolate. The merits for recommending cyclopentolate as a routine cycloplegic in children are discussed.
Further observations on use of atropine in the treatment of myopia. [2013]In order to further our observations on the effects of atropine eyedrops for the management of myopia, we conducted a retrospective study of seventy-nine (79) patients, followed over a ten-year period (1971 to 1980). The atropine sulfate drops were used daily in most cases, tapering the frequency in the later teenage years. In general, those children who showed a good initial response during their first year of treatment, continued to use them for several years. Bifocal or reading glasses were used and family acceptance was good. Those children who showed less favorable results in the first year or who had unconcerned parents, stopped the drops within a year or two and went back to glasses or later, contact lenses. The data support the fact that children with low refractive errors may well have "functional myopia," as opposed to the "axial myopia," that characterizes the higher levels of myopia. These low degree myopes are the best candidates for using atropine to reduce or diminish myopia changes.
[Drug kinetics in soft contact lenses. I. In vitro studies]. [2014]The in vitro kinetics (specifically, absorption and desorption) of drugs belonging to various pharmacological groups (atropine sulfate, gentamicin sulfate, dexamethasone, lecozyme, and poludan) in soft contact lenses (low-hydrophilic with 40% aqueous content and highly hydrophilic with 74% aqueous content. 0.2 and 0.7 mm thick) was studied by radiometry, as were the effects of chemical structure of a drug, hydrophilic properties and thickness of soft contact lenses, and temperature of solution on these processes.
[Objective refraction in black children: cyclopentolate and tropicamide combination, a reliable alternative to atropine?]. [2022]Cycloplegia allows for an objective refraction in children. Atropine is the gold standard but causes prolonged blurred vision. Cyclopentolate is less effective but less disabling. Tropicamide is a weak cycloplegic. The purpose of this study was to evaluate a cyclopentolate and tropicamide combination (CTA) versus atropine for refraction in black children.
Low-Concentration Atropine for Myopia Progression (LAMP) Study: A Randomized, Double-Blinded, Placebo-Controlled Trial of 0.05%, 0.025%, and 0.01% Atropine Eye Drops in Myopia Control. [2022]Low-concentration atropine is an emerging therapy for myopia progression, but its efficacy and optimal concentration remain uncertain. Our study aimed to evaluate the efficacy and safety of low-concentration atropine eye drops at 0.05%, 0.025%, and 0.01% compared with placebo over a 1-year period.
Myopia Outcome Study of Atropine in Children (MOSAIC): an investigator-led, double-masked, placebo-controlled, randomised clinical trial protocol. [2021]Background: The Myopia Outcome Study of Atropine in Children (MOSAIC) aims to explore the efficacy, safety, acceptability and mechanisms of action of 0.01% unpreserved atropine for myopia control in a European population. Methods: MOSAIC is an investigator-led, double-masked, placebo-controlled, randomised clinical trial (RCT) investigating the efficacy, safety and mechanisms of action of 0.01% atropine for managing progression of myopia. During Phase 1 of the trial, 250 children aged 6-16 years with progressive myopia instil eye drops once nightly in both eyes from randomisation to month 24. No treatment is given during Phase 2 from month 24 to 36 (washout period) for those participants initially randomised to the intervention arm (n=167), during which any potential rebound effects on cessation of treatment will be monitored. All participants initially assigned to the placebo (n=83) crossover to the intervention arm of the study for Phase 2, and from month 24 to 36, instil 0.01% atropine eye drops in both eyes once nightly. Further treatment and monitoring beyond 36 months is planned (Phase 3) and will be designed dependent on the outcomes of Phase 1. Results: The primary outcome measure is cycloplegic spherical equivalent refractive error progression at 24 months. Secondary outcome measures include axial length change as well as the rebound, safety and acceptability profile of 0.01% atropine. Additional analyses will include the mechanisms of action of 0.01% atropine for myopia control. Conclusions: The generalisability of results from previous clinical trials investigating atropine for myopia control is limited by the predominantly Asian ethnicity of previous study populations. MOSAIC is the first RCT to explore the efficacy, safety and mechanisms of action of unpreserved 0.01% atropine in a predominantly White population. Trial registration: ISRCTN: ISRCTN36732601 (04/10/2017), EudraCTdatabase 2016-003340-37 (03/07/2018).
Treatment of Rapid Progression of Myopia: Case Series and Literature Review. [2021]This retrospective case series demonstrates the combination of 0.05% atropine with MiSight® 1 day (Cooper vision, Sar Ramon, CA, USA) in rapid progression of myopia of 4 children. MiSight® 1 day is a peripheral defocus, center-distance soft contact lens and is effective at controlling moderate progression of myopia during the course of 1 year. The current case series included 2 females and 2 males with an average age of 9.68 ± 0.26 years and an average axial length of 24.81 ± 0.92 mm. Their myopic progression during the previous year was -1.45 ± 0.27 D. The children had not attempted any myopia control thus far. This relatively high increase prompted a combination treatment of daily instillation of 0.05% atropine and MiSight, a daily replacement soft contact lens. Cycloplegic refraction and a slit-lamp evaluation were performed every 6 months to confirm no adverse reactions or staining was present. The 8-item contact lens dry eye questionnaire (CLDEQ-8) score of these children was 10.66 ± 1.52. The average myopia progression at the end of 1 year decreased to -0.41 ± 0.11 D, and the average axial length increase was 0.28 ± 0.08 mm. To the best of the authors' knowledge, this is the first published study showing a combination of 0.05% atropine and peripheral defocus soft contact lenses indicating efficacy at controlling moderate myopia progression.
Low concentration atropine and myopia: a narrative review of the evidence for United Kingdom based practitioners. [2023]The prevalence of myopia is increasing across the world. Controlling myopia progression would be beneficial to reduce adverse outcomes such as retinal detachment and myopic maculopathy which are associated with increased axial length. Pharmacological control of myopia progression with atropine has been investigated since the 19th century and the benefits of slowing myopia progression are considered against the side-effects of near blur and photophobia. More recently, randomised trials have focused on determining the optimum concentration of atropine leading to low-concentration atropine being used to manage myopia progression by practitioners across the world. Currently, in the United Kingdom, there is no licensed pharmacological intervention for myopia management. The aim of this review is to interpret the available data to inform clinical practice. We conducted a narrative review of the literature and identified peer-reviewed randomised controlled trials using the search terms 'myopia' and 'atropine', limited to the English language. We identified two key studies, which were the Atropine in the Treatment Of Myopia (ATOM) and Low-concentration Atropine for Myopia Progression (LAMP). Further studies were identified using the above search terms and the references from the identified literature. Atropine 0.01% has a modest effect on controlling axial length progression. Atropine 0.05% appears to be superior to atropine 0.01% in managing myopia progression. There is a dose-dependent rebound effect when treatment is stopped. Atropine is a well-tolerated, safe, and effective intervention. Treatment would be needed for several years and into adolescence, until axial length progression is stable.
Safety and efficacy of 0.01% and 0.1% low-dose atropine eye drop regimens for reduction of myopia progression in Danish children: a randomized clinical trial examining one-year effect and safety. [2023]To investigate the efficacy and safety of 0.1% and 0.01% low-dose atropine eye drops in reducing myopia progression in Danish children.