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Myopia Control: a Comparison Study Between Atropine and MiSight

Primary Purpose

Myopia

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Atropine
MiSight contact lenses
Sponsored by
Ann & Robert H Lurie Children's Hospital of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Other

Other

Arm Label

Observation

Atropine

MiSight contact lenses

Arm Description

No treatment.

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

MiSight contact lenses. Daily wear for 2 years.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

compliance with treatment
reported side effects
success rate of contact lens fitting in the younger children
contact lens tolerance in the younger children

Full Information

First Posted
March 8, 2023
Last Updated
April 4, 2023
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT05815784
Brief Title
Myopia Control: a Comparison Study Between Atropine and MiSight
Official Title
Myopia Control in the Pediatric Population: a Comparison of MiSight, Naturalvue Multifocal, and Atropine 0.05%
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 20, 2023 (Anticipated)
Primary Completion Date
March 13, 2026 (Anticipated)
Study Completion Date
March 13, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
348 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Observation
Arm Type
No Intervention
Arm Description
No treatment.
Arm Title
Atropine
Arm Type
Other
Arm Description
0.05% atropine. One drop per eye per day for 2 years.
Arm Title
MiSight contact lenses
Arm Type
Other
Arm Description
MiSight contact lenses. Daily wear for 2 years.
Intervention Type
Drug
Intervention Name(s)
Atropine
Intervention Description
0.05% atropine. One drop per eye per day for 2 years.
Intervention Type
Device
Intervention Name(s)
MiSight contact lenses
Intervention Description
Daily wear for 2 years.
Primary Outcome Measure Information:
Title
axial length
Description
change in axial length (as measured by biometry) over a 2-year time period
Time Frame
2 years
Title
Refractive error
Description
change in refractive error over a 2-year time period
Time Frame
2 years
Secondary Outcome Measure Information:
Title
compliance with treatment
Time Frame
2 years
Title
reported side effects
Time Frame
2 years
Title
success rate of contact lens fitting in the younger children
Time Frame
2 years
Title
contact lens tolerance in the younger children
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chia-Ching Wu, MS
Phone
3122274202
Email
chwu@luriechildrens.org
First Name & Middle Initial & Last Name or Official Title & Degree
Hanta Ralay Ranaivo, PhD
Phone
3122276719
Email
hralay@luriechildrens.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magdalena Stec, OD
Organizational Affiliation
Ann & Robert H Lurie Children's Hospital of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ann & Robert H. Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chia-Ching Wu, MS
First Name & Middle Initial & Last Name & Degree
Hanta Ralay Ranaivo, PhD

12. IPD Sharing Statement

Learn more about this trial

Myopia Control: a Comparison Study Between Atropine and MiSight

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