Spectacle Prescribing in Early Childhood

NCT04728451 | Active Not Recruiting DMC

• 2 other identifiers: 1911187060UG1EY029657
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Astigmatism; Infant; Child, Preschool; Cognitive Development; Motor Development; Language Development; Child Development; Visual Acuity

Outcome Measures

Primary Outcomes (1)

• Cognitive Development

  Cognitive Scale Composite Score on the "Bayley Scales of Infant and Toddler Development, 3rd Edition". Tester is masked to the child's randomized group. Scores (continuous scale) are based on published age norms (mean =100, standard deviation = 15) and range from 40-160 with higher scores indicating better outcomes. A difference of ≥10 points between randomized groups will be considered clinically meaningful.

  Measured at the Developmental and Visual Assessment Visit (when the child is age 1155-1275 days)

Secondary Outcomes (5)

• Language Development

  Measured at the Developmental and Visual Assessment Visit (when the child is age 1155-1275 days)

• Motor Development

  Measured at the Developmental and Visual Assessment Visit (when the child is age 1155-1275 days)

• Social-Emotional Development

  Measured at the Developmental and Visual Assessment Visit (when the child is age 1155-1275 days)

• Adaptive Behavior

  Measured at the Developmental and Visual Assessment Visit (when the child is age 1155-1275 days)

• Visual Acuity

  Measured at the Developmental and Visual Assessment Visit (when the child is age 1155-1275 days)

Other Outcomes (1)

• Duration of spectacle wear

  From the date of dispensing of the first pair of spectacles at the Spectacle Prescription Verification Visit through the date of the Developmental and Visual Assessment Visit, up to 30 months.

Study Arms (2)

Full-Time Spectacle Wear

ACTIVE COMPARATOR

Parents are asked to encourage their child to wear the spectacles full-time (all waking hours). A study staff member works closely with families throughout the child's participation to provide support and encouragement and to make suggestions on methods parents can use to maximize spectacle wear.

Behavioral: Spectacle wear support; Device: Spectacles

Ad-Lib Spectacle Wear

ACTIVE COMPARATOR

Parents are asked to encourage their child to wear the spectacles as much as possible for the initial 30 days after dispensing, and thereafter to continue to offer the spectacles to the child but not force the child to wear them if they resist or refuse. Limited support for parents is provided with regard to maximizing spectacle wear.

Device: Spectacles

Interventions

Spectacle wear support BEHAVIORAL

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.

Full-Time Spectacle Wear

Spectacles DEVICE

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

Ad-Lib Spectacle Wear; Full-Time Spectacle Wear

Eligibility Criteria

• Age: 12 Months - 35 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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):

Sponsors & Collaborators

• University of Arizona: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

The University of Arizona

Tucson, Arizona, 85719, United States

Location

MeSH Terms

Conditions

Astigmatism

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Study Officials

• Erin M Harvey, Ph.D.

  University of Arizona

  PRINCIPAL INVESTIGATOR

• John D Twelker, O.D., Ph.D.

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 28, 2021
• Study Start: March 25, 2021
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: De-identified data will be available upon request after publication.
• Access Criteria: De-identified data will be available upon request after publication by contacting the study Principal Investigators.

Locations

US (1)