Delaying the Onset of Nearsightedness Until Treatment (DONUT) Clinical Trial

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Ohio State University
Study ID
NCT07567040
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Myopia

Eligibility Criteria

Sex
ALL
Age
6 Years - 11 Years
Healthy Volunteers
Accepted

Interventions

  • Atropine Sulfate 0.05% Oph Soln — DRUG
    Atropine Sulfate 0.05% Oph Soln compounded at the pharmacy
  • Placebo — DRUG
    Placebo drop with same formulation as treatment minus the atropine

Study Details

The aims of this clinical trial will test whether or not the onset of nearsightedness is delayed in a group of children randomized to nightly drops in 0.05% atropine in both eyes, in comparison to children who receiving nightly placebo drops in both eyes. The primary outcome is the two-year cumulative incidence of nearsightedness. The second aim of this project will determine whether atropine is associated with slower eye growth in children receiving nightly drops of atropine versus placebo.

Key Dates

Start date
May 6, 2026
Status verified
May 2026
Primary completion
May 15, 2028
Completion
May 15, 2028

Study Design

Enrollment
664 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: 0.05% Atropine
    0.05% atropine instilled in each eye nightly at bedtime
  • Placebo Comparator: Placebo
    Placebo drops instilled in each eye nightly at bedtime

Primary Outcome Measure

Cumulative incidence of myopia (spherical equivalent by Myopia Master) [ Time Frame: Two years ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
University of Alabama School of OptometryBirminghamAlabama35233
Safal Khanal, OD PhD
[email protected]
205-934-4558
University of California, Berkeley, School of OptometryBerkeleyCalifornia94720
Sarah Singh, OD PhD
[email protected]
510-664-5501
Southern California College of Optometry at Marshall B. Ketchum UniversityFullertonCalifornia92831
Angela Chen, OD
[email protected]
714-463-7569
Stanford UniversityPalo AltoCalifornia94303
Tawna Roberts, OD PhD
[email protected]
650-498-3154
Illinois College of OptometryChicagoIllinois60616
Jennifer Harthan, OD
[email protected]
312-949-7137
Indiana UniversityBloomingtonIndiana47405
Katie Connolly, OD
[email protected]
812-856-0976
New England College of OptometryBostonMassachusetts02115
Kristen Kerber, OD
[email protected]
617-587-5764
State University of New York College of OptometryNew YorkNew York10036
Xiaoying Zhu, OD PhD MD
[email protected]
212-938-5541
Case Western Reserve Department of OphthalmologyClevelandOhio44106
Adam J Peiffer, OD
[email protected]
440-684-1743
The Ohio State University College of OptometryColumbusOhio43210
Heather Anderson, OD PhD
[email protected]
614-247-5825
Pennsylvania College of Optometry at Drexel UniversityElkins ParkPennsylvania19027
Erin Jenewein, OD, MS
[email protected]
Southern College of OptometryMemphisTennessee38104
Marie Bodack, OD
[email protected]
901-722-3349
University of Houston College of OptometryHoustonTexas77004
Eric Ritchey, OD PhD
[email protected]
713-743-1933
Rosenberg College of Optometry at the University of Incarnate WordSan AntonioTexas78229
Michelle Aaron, OD
[email protected]
210-283-6821

Find similar trials in Birmingham, AL

By research site
University of Alabama School of Optometry· Birmingham, ALUniversity of California, Berkeley, School of Optometry· Berkeley, CASouthern California College of Optometry at Marshall B. Ketchum University· Fullerton, CAStanford University· Palo Alto, CAIllinois College of Optometry· Chicago, ILIndiana University· Bloomington, IN

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