Clinical trial NCT04728451: Spectacle Prescribing in Early Childhood
Official title: Spectacle Prescribing in Early Childhood (SPEC)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Astigmatism Bilateral
Eyeglasses
Keywords: Astigmatism
Infant
Child, Preschool
Cognitive Development
Motor Development
Language Development
Child Development
Visual Acuity
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2021-01-28
Enrollment: 88
Sex: ALL
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 criteria: 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)
  * 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):

  * Local redness and swelling of the eyelid consistent with contact dermatitis which resulted in the parent being informed that the child had a drug allergy to one of the dilating eye drops (proparacaine or cyclopentolate) or one of the carrier or preservative agents used in the formulation of these drops.

Primary outcomes:
measure: Cognitive Development
timeFrame: Measured at the Developmental and Visual Assessment Visit (when the child is age 1155-1275 days)
Secondary outcomes:
measure: Language Development
timeFrame: Measured at the Developmental and Visual Assessment Visit (when the child is age 1155-1275 days)
measure: Motor Development
timeFrame: Measured at the Developmental and Visual Assessment Visit (when the child is age 1155-1275 days)
measure: Social-Emotional Development
timeFrame: Measured at the Developmental and Visual Assessment Visit (when the child is age 1155-1275 days)
measure: Adaptive Behavior
timeFrame: Measured at the Developmental and Visual Assessment Visit (when the child is age 1155-1275 days)
measure: Visual Acuity
timeFrame: Measured at the Developmental and Visual Assessment Visit (when the child is age 1155-1275 days)
Other outcomes:
measure: Duration of spectacle wear
timeFrame: 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.
Locations:
city: Tucson
country: United States
facility: The University of Arizona
state: Arizona
Study officials:
affiliation: University of Arizona
name: Erin M Harvey, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arizona
name: John D Twelker, O.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: