Delaying the Onset of Nearsightedness Until Treatment Study (DONUT)

The Ohio State University

Status and phase: Withdrawn; Phase 1

Conditions: Myopia

Treatments: Drug: Atropine Ophthalmic

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06029530

DONUT

Details and patient eligibility

About

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

Full 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%).

Sex: All

Ages: 6 to 11 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups

0.01% Atropine

Active Comparator group

Description:

0.01% atropine eye drops

Treatment:

Drug: Atropine Ophthalmic

0.03% Atropine

Active Comparator group

Description:

0.03% atropine eye drops

Treatment:

Drug: Atropine Ophthalmic

0.05% atropine

Active Comparator group

Description:

0.05% atropine eye drops

Treatment:

Drug: Atropine Ophthalmic