Myopia Control: a Comparison Study Between Atropine and M... | NCT05815784

Studies
Myopia Control: a Comparison Study Between Atropine and MiSight

NCT05815784

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Status

Recruiting

Last Update Posted

Nov 19, 2024Actual

Enrollment

348Estimated

Phase

Phase 2

Conditions

Myopia

Interventions

Atropine
MiSight contact lenses

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2, 2023Actual

Primary Completion Date

Mar 13, 2026Estimated

Completion Date

Mar 13, 2026Estimated

First Submitted Date

Mar 8, 2023

First Submission Date that Met QC Criteria

Apr 4, 2023

First Posted Date

Apr 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2024

Last Update Posted Date

Nov 19, 2024Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

348Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Atropine	Drug	0.05% atropine. One drop per eye per day for 2 years.	Atropine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
compliance with treatment		2 years
reported side effects		2 years
success rate of contact lens fitting in the younger children

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chia-Ching Wu, MS	Contact	3122274202		chwu@luriechildrens.org
Hanta Ralay Ranaivo, PhD	Contact	3122276719		hralay@luriechildrens.org

Overall Officials

Name	Affiliation	Role
Magdalena Stec, OD	Ann & Robert H Lurie Children's Hospital of Chicago	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ann & Robert H. Lurie Children's Hospital of Chicago	Recruiting	Chicago	Illinois	60611	United States

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

ID	Term
D001286	Atropine Derivatives
D014326	Tropanes
D053961	Azabicyclo Compounds
D001372	Aza Compounds