Myopia Control: a Comparison Study Between Atropine and MiSight

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

348 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-02

Study Completion Date

2026-03-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This research project aims to provide additional knowledge of pharmacological and optical methods of myopia control and to gain a better understanding of the biometry of the pediatric eye, which contributes to the onset and progression of myopia. As a result, this study will improving our best practices for myopia control in pediatric patients.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effects of Low-dose Atropine and Orthokeratology in Pediatric Myopia Control

NCT05478356

Myopia

UNKNOWN NA

Low Concentration Atropine in the Prevention of Myopia in Children.

NCT05939882

Myopia, Progressive

UNKNOWN NA

Myopia Intervention in Children and Adolescents and Establishment of a Precise Intervention Model

NCT05357326

Myopia

UNKNOWN PHASE4

Evaluating the Efficacy of the Combination of Multi-zonal Contact Lens and Atropine for Controlling Myopia Progression

NCT06765603

Myopia

NOT_YET_RECRUITING PHASE2

Low-dose Atropine for Myopia Control in Children

NCT03865160

Myopia, Progressive

ACTIVE_NOT_RECRUITING PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myopia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Observation

No treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Atropine

0.05% atropine. One drop per eye per day for 2 years.

Group Type OTHER

Atropine

Intervention Type DRUG

0.05% atropine. One drop per eye per day for 2 years.

MiSight contact lenses

MiSight contact lenses. Daily wear for 2 years.

Group Type OTHER

MiSight contact lenses

Intervention Type DEVICE

Daily wear for 2 years.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Atropine

0.05% atropine. One drop per eye per day for 2 years.

Intervention Type DRUG

MiSight contact lenses

Daily wear for 2 years.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Children age of 5-12 years old at their baseline exam
* Children with a spherical equivalent refractive error of +0.50D (minimal hyperopia) to -7.50 D (high myopia)
* Gestational age ≥ 32 weeks.
* Birth weight \>1500g.

Exclusion Criteria

* Current or previous form of myopia control
* Current or previous use of bifocal, progressive- addition lenses, or multifocal contact lenses
* Known atropine allergy or contact lens intolerance (allergy to only one can still allow enrollment in the other group)
* Abnormality of cornea, lens, central retina, iris, or ciliary body
* Current or prior history of manifest strabismus, amblyopia, or nystagmus
* Current or previous myopia treatment with atropine, pirenzepine or another anti-muscarinic agent.
* Current or previous use of bifocals, progressive-addition lenses, or multi-focal contact lenses.
* Current or previous use of orthoK, rigid gas permeable, or other contact lenses being used to reduce myopia progression.
* Abnormality of the cornea, lens, central retina, iris, or ciliary body.
* Prior eyelid, strabismus, intraocular, or refractive surgery.
* Down syndrome or cerebral palsy.
* Diseases known to affect accommodation, vergence, or ocular motility (e.g., multiple sclerosis, Grave's disease, myasthenia gravis, diabetes mellitus, Parkinson's disease)
* Existing ocular conditions (e.g., retinal disease, cataracts, ptosis) or systemic/neurodevelopmental conditions (e.g., Down syndrome) which may influence refractive development
* Any condition that in the judgement of the investigator could potentially influence refractive development.
* Existing conditions that may affect the long-term health of the eye or require regular pharmacologic treatment that may adversely interact with study medication (e.g., JIA, glaucoma, diabetes mellitus, pre-diabetes)
* Inability to comprehend and/or perform any study-related clinical tests

Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No