Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
88 participants
INTERVENTIONAL
2021-03-25
2027-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Full-Time Spectacle Wear
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.
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.
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
Ad-Lib Spectacle Wear
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.
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
Interventions
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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.
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
12 Months
35 Months
ALL
Yes
Sponsors
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National Eye Institute (NEI)
NIH
University of Arizona
OTHER
Responsible Party
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Dan Twelker
Professor
Principal Investigators
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Erin M Harvey, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Arizona
John D Twelker, O.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Arizona
Locations
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The University of Arizona
Tucson, Arizona, United States
Countries
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Other Identifiers
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1911187060
Identifier Type: -
Identifier Source: org_study_id