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Anticholinergic Agent
Atropine vs MiSight Contact Lenses for Near-Sightedness
Phase 2
Waitlist Available
Led By Magdalena Stec, OD
Research Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial looks to improve our understanding of myopia and how to best prevent and control it in kids.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Atropine may cause light sensitivity or blurry vision up close due to its effect on pupil dilation. MiSight contacts might lead to discomfort, redness or infection if not used properly.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Refractive error
axial length
Secondary outcome measures
compliance with treatment
contact lens tolerance in the younger children
reported side effects
+1 moreTrial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atropine
2008
Completed Phase 4
~3230
Find a Location
Who is running the clinical trial?
Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor
256 Previous Clinical Trials
5,187,532 Total Patients Enrolled
Magdalena Stec, ODPrincipal InvestigatorAnn & Robert H Lurie Children's Hospital of Chicago
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.I have had surgery on my eyelid, for eye muscle issues, inside my eye, or to correct my vision.I have an eye condition affecting my cornea, lens, retina, iris, or ciliary body.I have or had crossed eyes, lazy eye, or involuntary eye movement.I have eye conditions or other health issues that could affect my vision development.I have a condition like glaucoma or diabetes that could affect my eyes or interact with the study drug.I can understand and perform all required study-related tests.I am between 5 and 12 years old.My child's vision prescription is between +0.50 and -7.50.
Research Study Groups:
This trial has the following groups:- Group 1: Observation
- Group 2: Atropine
- Group 3: MiSight contact lenses
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How might I go about joining this medical experiment?
"The criteria for inclusion in this study includes young individuals of between 5 and 12 years old with myopia, and a total of 348 participants are needed."
Answered by AI
Are elderly individuals being included in the parameters of this clinical trial?
"The requirements for this trial dictate that all participants are between the ages of 5 to 12. Separately, 79 medical studies accept patients under 18 and 21 clinical trials seek individuals over 65 years old."
Answered by AI
How hazardous is this method of treatment for individuals?
"A score of 2 was attributed to the safety rating as there is empirical evidence that confirms its security but not enough data available on efficacy."
Answered by AI
Are new participants welcomed into this research program?
"Unfortunately, this clinical trial is not seeking any more participants. It was first posted on April 20th 2023 and finalized edits were made on the 4th of April 2023. Despite that, there are still 115 other studies actively recruiting individuals at present."
Answered by AI
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