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Delaying the Onset of Nearsightedness Until Treatment Study

Phase 1
Withdrawn
Conditions
Myopia
Interventions
Registration Number
NCT06029530
Lead Sponsor
Ohio State University
Brief Summary

Participants eligible for the study will be randomized to one of three concentrations of atropine and followed for a month.

Detailed Description

Participants will be identified through screening that fit the criteria of a pre-myopic child, which will depend on age and the amount of refractive error at that time. These children will be randomized for a pilot study measuring compliance in nightly eye drop administration. The outcome will be thirty days after randomization, and will assess whether or not there is a difference in compliance between one of three dosages of atropine (0.01%, 0.03%, and 0.05%).

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
Inclusion Criteria
  • Age: 6-11 years

  • Refractive error measured in spherical equivalent, one eye meets criterion

    • 6 years old: 0.50 to +0.38
    • 7 years old: 0.50 to +0.25
    • 8-11 years old: 0.50 to plano
  • Anisometropia: spherical equivalent <1.50 D

  • Astigmatism: <1.50 in both eyes

  • Myopia: Less myopic than -0.74 D, both eyes

Exclusion Criteria

● Myopic

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
0.01% AtropineAtropine Ophthalmic0.01% atropine eye drops
0.03% AtropineAtropine Ophthalmic0.03% atropine eye drops
0.05% atropineAtropine Ophthalmic0.05% atropine eye drops
Primary Outcome Measures
NameTimeMethod
Compliance percentage30 days

A comparison of the compliance percentage with eye drop administration

Secondary Outcome Measures
NameTimeMethod
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