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

First listed
May 5, 2026
Start date
May 27, 2026
Status verified
Aug 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 (13)

FacilityCityStateZIPSite coordinators
University of Alabama School of OptometryBirminghamAlabama35233
Sindhu Gurrala
[email protected]
205-975-3881
University of California, Berkeley, School of OptometryBerkeleyCalifornia94720
Yoofi Mensah
[email protected]
510-207-4758
Southern California College of Optometry at Marshall B. Ketchum UniversityFullertonCalifornia92831
Susan Parker
[email protected]
714-463-7580
Stanford UniversityPalo AltoCalifornia94303
Tawna Roberts, OD PhD
[email protected]
650-498-3154
Illinois College of OptometryChicagoIllinois60616
Jessica Martinez
[email protected]
312-949-7340
Indiana UniversityBloomingtonIndiana47405
Amy Peterson, OD
[email protected]
812-856-0242
New England College of OptometryBostonMassachusetts02115
Tamara Khanjyan
[email protected]
617-587-5723
State University of New York College of OptometryNew YorkNew York10036
Keyana Hunte
[email protected]
212-938-4052
Case Western Reserve Department of OphthalmologyClevelandOhio44106
Adam J Peiffer, OD
[email protected]
440-684-1743
The Ohio State University College of OptometryColumbusOhio43210
Alexis Koston
[email protected]
614-292-0200
Pennsylvania College of Optometry at Drexel UniversityElkins ParkPennsylvania19027
Erin Jenewein, OD, MS
[email protected]
Southern College of OptometryMemphisTennessee38104
Elaine Turcotte
[email protected]
901-730-5004
University of Houston College of OptometryHoustonTexas77004
Onose Okoeguale
[email protected]
713-743-1994

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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