Delaying the Onset of Nearsightedness Until Treatment Study

Myopia Clinical Trial

— DONUT  

Official title:

Delaying the Onset of Nearsightedness Until Treatment Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT06029530
• Other study ID #: DONUT
• Status: Withdrawn
• Phase: Phase 1
• Start date: January 1, 2024
• Est. completion date: August 31, 2024

Study information

• Verified date: April 2024
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Intervention

Drug:
• Atropine Ophthalmic
eye drops to be administered once daily

Locations

Country	Name	City	State
n/a

Sponsors (14)

Lead Sponsor

Collaborator

Ohio State University

Case Western Reserve University, Illinois College of Optometry, Indiana University, New England College of Optometry, Pennsylvania College of Optometry, Southern California College of Optometry at Marshall B. Ketchum University, Southern College of Optometry, Stanford University, State University of New York, University of California, Berkeley, University of Houston, University of Missouri, St. Louis, University of the Incarnate Word

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance percentage	A comparison of the compliance percentage with eye drop administration	30 days