348 Participants Needed
Ann & Robert H Lurie Children's Hospital of Chicago logo

Atropine vs MiSight Contact Lenses for Near-Sightedness

Recruiting in Chicago (>99 mi)
CW
HR
Overseen ByHanta Ralay Ranaivo, PhD
Age: < 18
Sex: Any
Trial Phase: Phase 2
Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using any form of myopia control or certain contact lenses, you may not be eligible to participate.

What data supports the effectiveness of the treatment for near-sightedness?

Research shows that using 0.05% atropine eye drops combined with MiSight contact lenses can significantly slow down the progression of near-sightedness in children. In a study, this combination reduced the average myopia progression from -1.45 to -0.41 over one year, indicating its effectiveness in controlling myopia.12345

Is the combination of atropine and MiSight contact lenses safe for treating near-sightedness?

Research shows that using low-concentration atropine and MiSight contact lenses is generally safe for children with near-sightedness. Studies have monitored children for adverse reactions and found no significant safety concerns over a year of treatment.14678

How does the treatment of atropine and MiSight contact lenses for near-sightedness differ from other treatments?

The combination of 0.05% atropine eye drops and MiSight contact lenses is unique because it targets myopia (near-sightedness) progression by using both a pharmacological approach and a specialized contact lens that alters how light focuses on the retina. This dual approach has shown effectiveness in significantly slowing myopia progression in children, which is not typically achieved with standard glasses or contact lenses alone.136910

Research Team

MS

Magdalena Stec, OD

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

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.

Inclusion Criteria

I am between 5 and 12 years old.
My child's vision prescription is between +0.50 and -7.50.
Gestational age ≥ 32 weeks
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Exclusion Criteria

Current or previous form of myopia control
I do not have conditions like MS, Grave's, myasthenia gravis, diabetes, or Parkinson's affecting my eye movement.
I have been treated for nearsightedness with specific eye drops.
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 0.05% atropine drops or MiSight contact lenses for myopia control

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Atropine
  • MiSight contact lenses
Trial OverviewThe 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.
Participant Groups
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

Who Is Running the Clinical Trial?

Ann & Robert H Lurie Children's Hospital of Chicago

Lead Sponsor

Trials
275
Recruited
5,182,000+

Findings from Research

The combination of 0.05% atropine eye drops with MiSight® 1 day contact lenses effectively reduced myopia progression in four children, decreasing their average myopia change from -1.45 D to -0.41 D over one year.
This case series, involving children with an average age of 9.68 years, is the first to demonstrate the efficacy of this combination treatment in controlling moderate myopia progression, with no reported adverse reactions during the study.
Treatment of Rapid Progression of Myopia: Case Series and Literature Review.Erdinest, N., London, N., Levinger, N., et al.[2021]
In a study involving 97 Danish children aged 6 to 12, low-dose atropine eye drops (0.1% and 0.01%) were found to be safe over a 12-month period, with most reported adverse events being mild.
The treatment showed a modest reduction in myopia progression, with the 0.1% group experiencing 0.24 D less progression in spherical equivalent refraction compared to placebo, although this result was not statistically significant after adjustments.
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.Hansen, NC., Hvid-Hansen, A., Møller, F., et al.[2023]
A retrospective study of 79 patients over ten years found that atropine eyedrops can effectively manage myopia, especially in children with low refractive errors, who are more likely to benefit from the treatment.
Children who responded well to atropine in the first year tended to continue treatment, while those with less favorable results often stopped, indicating the importance of early response in treatment adherence.
Further observations on use of atropine in the treatment of myopia.Brenner, RL.[2013]

References

Treatment of Rapid Progression of Myopia: Case Series and Literature Review. [2021]
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]
Further observations on use of atropine in the treatment of myopia. [2013]
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 and myopia: a narrative review of the evidence for United Kingdom based practitioners. [2023]
[Objective refraction in black children: cyclopentolate and tropicamide combination, a reliable alternative to atropine?]. [2022]
[Prolonged mydriasis caused by Lamaline]. [2013]
Myopia Outcome Study of Atropine in Children (MOSAIC): an investigator-led, double-masked, placebo-controlled, randomised clinical trial protocol. [2021]
9.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Drug kinetics in soft contact lenses. I. In vitro studies]. [2014]
Status of cyclopentolate as a cycloplegic in children: a comparison with atropine and homatropine. [2019]