RECRUITING

Myopia Control: a Comparison Study Between Atropine and MiSight

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Conditions

Myopia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Myopia Control in the Pediatric Population: a Comparison of MiSight, Naturalvue Multifocal, and Atropine 0.05%

Quick Facts

Study Start:2023-05-02
Study Completion:2026-03-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05815784

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years to 12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Children age of 5-12 years old at their baseline exam
  2. * Children with a spherical equivalent refractive error of +0.50D (minimal hyperopia) to -7.50 D (high myopia)
  3. * Gestational age ≥ 32 weeks.
  4. * Birth weight \>1500g.
  1. * Current or previous form of myopia control
  2. * Current or previous use of bifocal, progressive- addition lenses, or multifocal contact lenses
  3. * Known atropine allergy or contact lens intolerance (allergy to only one can still allow enrollment in the other group)
  4. * Abnormality of cornea, lens, central retina, iris, or ciliary body
  5. * Current or prior history of manifest strabismus, amblyopia, or nystagmus
  6. * Current or previous myopia treatment with atropine, pirenzepine or another anti-muscarinic agent.
  7. * Current or previous use of bifocals, progressive-addition lenses, or multi-focal contact lenses.
  8. * Current or previous use of orthoK, rigid gas permeable, or other contact lenses being used to reduce myopia progression.
  9. * Abnormality of the cornea, lens, central retina, iris, or ciliary body.
  10. * Prior eyelid, strabismus, intraocular, or refractive surgery.
  11. * Down syndrome or cerebral palsy.
  12. * Diseases known to affect accommodation, vergence, or ocular motility (e.g., multiple sclerosis, Grave's disease, myasthenia gravis, diabetes mellitus, Parkinson's disease)
  13. * Existing ocular conditions (e.g., retinal disease, cataracts, ptosis) or systemic/neurodevelopmental conditions (e.g., Down syndrome) which may influence refractive development
  14. * Any condition that in the judgement of the investigator could potentially influence refractive development.
  15. * 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)
  16. * Inability to comprehend and/or perform any study-related clinical tests

Contacts and Locations

Study Contact

Chia-Ching Wu, MS
CONTACT
3122274202
chwu@luriechildrens.org
Hanta Ralay Ranaivo, PhD
CONTACT
3122276719
hralay@luriechildrens.org

Principal Investigator

Magdalena Stec, OD
PRINCIPAL_INVESTIGATOR
Ann & Robert H Lurie Children's Hospital of Chicago

Study Locations (Sites)

Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
United States

Collaborators and Investigators

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

  • Magdalena Stec, OD, PRINCIPAL_INVESTIGATOR, Ann & Robert H Lurie Children's Hospital of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-02
Study Completion Date2026-03-13

Study Record Updates

Study Start Date2023-05-02
Study Completion Date2026-03-13

Terms related to this study

Additional Relevant MeSH Terms

  • Myopia