Spectacle Prescribing in Early Childhood

Astigmatism Bilateral Clinical Trial

— SPEC  

Official title:

Spectacle Prescribing in Early Childhood (SPEC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04728451
• Other study ID #: 1911187060
• Secondary ID: UG1EY029657
• Status: Recruiting
• Phase: N/A
• Start date: March 26, 2021
• Est. completion date: February 2027

Study information

• Verified date: November 2023
• Source: University of Arizona
• Contact: Erin M Harvey, Ph.D.
• Phone: 520-324-3160
• Email: emharvey[@]arizona.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: February 2027
• Est. primary completion date: February 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 35 Months

Eligibility

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.

Related Conditions & MeSH terms

• Astigmatism
• Astigmatism Bilateral
• Eyeglasses

Intervention

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

Locations

Country	Name	City	State
United States	The University of Arizona	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duration of spectacle wear	Objective measures of duration of spectacle wear (hours/day) assessed objectively with a TheraMon® sensor attached to the child's spectacles. Temperature samples are recorded by the sensor every 15 minutes.	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.
Primary	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	Language Development	Language 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	Motor Development	Motor 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	Social-Emotional Development	Social-Emotional 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	Adaptive Behavior	Adaptive Behavior 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	Visual Acuity	Binocular visual acuity tested using the Amblyopia Treatment Study HOTV Protocol. Child wears most recent prescription for testing (or no spectacles, if discontinued by study doctor). Tester is masked to the child's randomized group. Acuity is recorded and analyzed as log MAR values (continuous scale). A difference of 0.10 log MAR between randomized groups will be considered clinically meaningful.	Measured at the Developmental and Visual Assessment Visit (when the child is age 1155-1275 days)