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Spectacle Prescribing in Early Childhood

NCT04728451 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2024-12-19

No results posted yet for this study

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).

Conditions

  • Astigmatism Bilateral
  • Eyeglasses

Interventions

BEHAVIORAL

Spectacle wear support

Parents of children in the full-time group are provided with encouragement, support, and counseling throughout the study in order to maximize their child's spectacle wear.

DEVICE

Spectacles

Children prescribed and provided spectacles with full correction of their refractive error, with the exception of prescriptions with ≥ +1.50D sphere (plus cylinder notation) in the least hyperopic eye, which will be symmetrically reduced by 1.00D

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • University of Arizona

    lead OTHER

Principal Investigators

  • Erin M Harvey, Ph.D. · University of Arizona

  • John D Twelker, O.D., Ph.D. · University of Arizona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
35 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-25
Primary Completion
2027-02-28
Completion
2027-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04728451 on ClinicalTrials.gov