Myopia Control: a Comparison Study Between Atropine and MiSight

NCT05815784 | Recruiting Phase 2 FDA Drug FDA Device

• 1 other identifier: 2022-5570
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

• axial length

  change in axial length (as measured by biometry) over a 2-year time period

  2 years

• Refractive error

  change in refractive error over a 2-year time period

  2 years

Secondary Outcomes (4)

• compliance with treatment

  2 years

• reported side effects

  2 years

• success rate of contact lens fitting in the younger children

  2 years

• contact lens tolerance in the younger children

  2 years

Study Arms (3)

Observation

NO INTERVENTION

No treatment.

Atropine

OTHER

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

Drug: Atropine

MiSight contact lenses

OTHER

MiSight contact lenses. Daily wear for 2 years.

Device: MiSight contact lenses

Interventions

Atropine DRUG

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

Atropine

MiSight contact lenses DEVICE

Daily wear for 2 years.

MiSight contact lenses

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead

Study Sites (1)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Myopia

Interventions

Atropine

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Magdalena Stec, OD

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chia-Ching Wu, MS

CONTACT

3122274202; chwu@luriechildrens.org

Hanta Ralay Ranaivo, PhD

CONTACT

3122276719; hralay@luriechildrens.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Ophthalmology

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: April 18, 2023
• Study Start: May 2, 2023
• Primary Completion: March 13, 2026
• Study Completion: March 13, 2026
• Last Updated: November 19, 2024

Record last verified: 2024-11

Locations

US (1)