Spectacle Prescribing in Early Childhood

Spectacle Prescribing in Early Childhood (SPEC)

NCT04728451•University of Arizona

Summary

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).

Detailed Description

The benefits and drawbacks of spectacle treatment for bilateral astigmatism in young children are not known. The SPEC study compares outcomes for young children (12 to \< 35 months of age) with astigmatism meeting spectacle prescribing recommendations and randomized to either Full-Time spectacle wear (encouraged and reinforced) or Ad Lib spectacle wear (only as accepted by the child). The primary outcome analysis compares cognitive development at 38-42 months in children randomized to the Full-Time and Ad Lib groups. Secondary analyses compare Language, Motor, Social-Emotional, and Adaptive Behavior developmental outcomes and visual acuity outcome for children randomized to the Full-Time and Ad Lib groups.

Eligibility

Age

1 - 2 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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.

Exclusion Criteria

•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)
+16 more criteria

Locations (1)

The University of Arizona

Tucson, Arizona, United States

Key Dates

Start Date

March 25, 2021

Primary Completion Date

February 1, 2027

Completion Date

February 1, 2027

Last Updated

December 19, 2024

Enrollment

ESTIMATED participants

Conditions

Astigmatism BilateralEyeglasses

Interventions

Spectacle wear support

BEHAVIORAL

Spectacles

DEVICE