What is the mechanism of action of this treatment?

The most common treatments for Near-sightedness (myopia) include pharmacological agents like atropine eye drops and optical devices such as multifocal contact lenses and orthokeratology lenses. Atropine eye drops work by temporarily paralyzing the muscles responsible for focusing, which can slow the progression of myopia by reducing eye elongation. Multifocal contact lenses and orthokeratology lenses alter the way light enters the eye, which can help to reshape the cornea and control eye growth. These treatments are crucial for Near-sightedness patients as they can significantly slow the progression of myopia, reducing the risk of severe vision problems and associated complications later in life.

What side effects are associated with this type of intervention?

Common treatments for near-sightedness, such as atropine eye drops and MiSight contact lenses, have known side effects. Atropine can cause light sensitivity, blurred near vision, and allergic reactions. MiSight contact lenses may lead to discomfort, dryness, or irritation. Both treatments are effective in managing myopia progression but come with these potential side effects.

What prior FDA approvals exist?

The FDA has approved various treatments for near-sightedness, including pharmacological agents like low-dose atropine eye drops, which have been shown to slow the progression of myopia in children. Additionally, optical devices such as multifocal contact lenses and orthokeratology (ortho-k) lenses, which temporarily reshape the cornea to reduce myopia, have also received FDA approval. These treatments aim to alter eye growth patterns and change the way light enters the eye, thereby controlling the progression of myopia.

What other types of research exist?

Promising novel alternatives for treating near-sightedness in 2024 include: 1) Orthokeratology (Ortho-K) lenses, which temporarily reshape the cornea to reduce myopia progression. 2) Low-dose atropine eye drops, which have shown efficacy in slowing myopia progression in children. 3) Newer surgical techniques such as small incision lenticule extraction (SMILE), which offers a minimally invasive option for correcting myopia. 4) Emerging technologies like peripheral defocus contact lenses and spectacle lenses designed to control myopia progression by altering peripheral light focus.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

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 more

Trial 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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Near-sightedness (myopia) include pharmacological agents like atropine eye drops and optical devices such as multifocal contact lenses and orthokeratology lenses. Atropine eye drops work by temporarily paralyzing the muscles responsible for focusing, which can slow the progression of myopia by reducing eye elongation. Multifocal contact lenses and orthokeratology lenses alter the way light enters the eye, which can help to reshape the cornea and control eye growth. These treatments are crucial for Near-sightedness patients as they can significantly slow the progression of myopia, reducing the risk of severe vision problems and associated complications later in life.

The interactions of genes, age, and environment in glaucoma pathogenesis.Update on uveomeningoencephalitides.

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Who is running the clinical trial?

Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor

261 Previous Clinical Trials

5,188,930 Total Patients Enrolled

Magdalena Stec, ODPrincipal InvestigatorAnn & Robert H Lurie Children's Hospital of Chicago

Media Library

Atropine (Anticholinergic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05815784 — Phase 2

Near-sightedness Research Study Groups: Observation, Atropine, MiSight contact lenses

Near-sightedness Clinical Trial 2023: Atropine Highlights & Side Effects. Trial Name: NCT05815784 — Phase 2

Atropine (Anticholinergic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05815784 — Phase 2

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