Spectacle Prescribing in Early Childhood

Running, not enrolling · Not applicable

Conditions studied: Astigmatism Bilateral, Eyeglasses

In brief

The purpose of this study is to compare developmental outcome for young children (12 to 35 months of age) with astigmatism meeting American Academy of Ophthalmology spectacle prescribing guidelines and who are prescribed and provided spectacles for either Full-Time wear (encouraged and reinforced) or Ad Lib wear (wear dependent on child acceptance).

Key facts

Study ID

NCT04728451

Run by

University of Arizona

People needed

88

Starts

2021-03-25

Expected to finish

2027-02-01

Last updated by the study team

2024-12-19

Who can join

Age: 1 and older, up to 3. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Parent/guardian provision of signed and dated informed consent form for Baseline/Eligibility Examination.
• Completion of Baseline/Eligibility Examination with cycloplegia.
• Bilateral astigmatism: Astigmatism ≥2.25D in the most astigmatic eye and ≥1.75D in the fellow eye based on manual cycloplegic retinoscopy conducted at Baseline/Eligibility Examination.
• Parent/guardian willing to accept assignment to either randomized group.
• Parent/guardian provision of signed and dated informed consent form for randomized SPEC Study.
• Parent willing to commit to study visits every 180 days, to be contacted (phone, email, or text) for reports of spectacle wear, and to allow their child to wear the TheraMon® sensor on the spectacle headband.
• Child and Family are primarily English or Spanish speaking.
• Parent/guardian does not anticipate moving out of Tucson area prior to their child reaching age 1275 days (approximately age 3 ½ years).
• Parent/guardian has not enrolled another child in the SPEC trial.

You may not qualify if…

• Gestational age <32 weeks (per parent report).
• Anisometropia ≥1.50 D spherical equivalent per manual cycloplegic retinoscopy conducted at the Baseline/Eligibility Examination.
• Current manifest strabismus per Baseline/Eligibility Examination.
• Ocular pathology per Baseline/Eligibility Examination (H44* or H25* diagnosis code).
• Previously diagnosed manifest strabismus or other ocular abnormalities (per parent report and per medical record):
• H25* (Cataract)
• H44* (Disorders of the Globe)
• H50* (Strabismus)
• H55* (Irregular Eye Movement and Nystagmus)
• Q15.0 (Congenital Glaucoma)
• Other diagnosis of an ocular abnormality
• Previous spectacle wear, amblyopia therapy, or vision therapy (per parent report and per medical record).
• H53* (Amblyopia)
• Other spectacle wear, amblyopia therapy, or vision therapy
• Current or previous diagnosis of developmental or neurological conditions (per parent report and per medical record):
• H90.5 Congenital Deafness, and related disorders of hearing loss.
• G40.909 Epilepsy or other seizure disorder.
• P07.34 Prematurity 31 weeks, and other prematurity less than 32 weeks.
• P91.6 Hypoxic Ischemic Encephalopathy
• Q90.9 Down Syndrome, and other congenital syndromes associated with developmental delay.
• Q04.4 Septo-Optic Dysplasia
• Q91-Q92 Trisomy Other (13, 18, partial, complete, unbalanced translocations, mosaicism, duplications)
• R62.50 Developmental Delay, and related disorders exhibiting a delay in one or more streams of development (e.g. language, fine motor, gross motor, social).
• Other diagnosis of a developmental or neurological condition
• History of allergic response to dilating eye drops (per parent report):

Where it is running

• The University of Arizona — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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