ACTIVE_NOT_RECRUITING

Spectacle Prescribing in Early Childhood

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Conditions

Astigmatism BilateralEyeglassesAstigmatismInfantChild, PreschoolCognitive DevelopmentMotor DevelopmentLanguage DevelopmentChild DevelopmentVisual Acuity

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Spectacle Prescribing in Early Childhood (SPEC)

Quick Facts

Study Start:2021-03-25
Study Completion:2027-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04728451

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Months to 35 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Parent/guardian provision of signed and dated informed consent form for Baseline/Eligibility Examination.
  2. * Completion of Baseline/Eligibility Examination with cycloplegia.
  3. * 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.
  4. * Parent/guardian willing to accept assignment to either randomized group.
  5. * Parent/guardian provision of signed and dated informed consent form for randomized SPEC Study.
  6. * 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.
  7. * Child and Family are primarily English or Spanish speaking.
  8. * Parent/guardian does not anticipate moving out of Tucson area prior to their child reaching age 1275 days (approximately age 3 ½ years).
  9. * Parent/guardian has not enrolled another child in the SPEC trial.
  1. * Gestational age \<32 weeks (per parent report).
  2. * Anisometropia ≥1.50 D spherical equivalent per manual cycloplegic retinoscopy conducted at the Baseline/Eligibility Examination.
  3. * Current manifest strabismus per Baseline/Eligibility Examination.
  4. * Ocular pathology per Baseline/Eligibility Examination (H44\* or H25\* diagnosis code).
  5. * Previously diagnosed manifest strabismus or other ocular abnormalities (per parent report and per medical record):
  6. * H25\* (Cataract)
  7. * H44\* (Disorders of the Globe)
  8. * H50\* (Strabismus)
  9. * H55\* (Irregular Eye Movement and Nystagmus)
  10. * Q15.0 (Congenital Glaucoma)
  11. * Other diagnosis of an ocular abnormality
  12. * Previous spectacle wear, amblyopia therapy, or vision therapy (per parent report and per medical record).
  13. * H53\* (Amblyopia)
  14. * Other spectacle wear, amblyopia therapy, or vision therapy
  15. * Current or previous diagnosis of developmental or neurological conditions (per parent report and per medical record):
  16. * H90.5 Congenital Deafness, and related disorders of hearing loss.
  17. * G40.909 Epilepsy or other seizure disorder.
  18. * P07.34 Prematurity 31 weeks, and other prematurity less than 32 weeks.
  19. * P91.6 Hypoxic Ischemic Encephalopathy
  20. * Q90.9 Down Syndrome, and other congenital syndromes associated with developmental delay.
  21. * Q04.4 Septo-Optic Dysplasia
  22. * Q91-Q92 Trisomy Other (13, 18, partial, complete, unbalanced translocations, mosaicism, duplications)
  23. * 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).
  24. * Other diagnosis of a developmental or neurological condition
  25. * History of allergic response to dilating eye drops (per parent report):
  26. * 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.

Contacts and Locations

Principal Investigator

Erin M Harvey, Ph.D.
PRINCIPAL_INVESTIGATOR
University of Arizona
John D Twelker, O.D., Ph.D.
PRINCIPAL_INVESTIGATOR
University of Arizona

Study Locations (Sites)

The University of Arizona
Tucson, Arizona, 85719
United States

Collaborators and Investigators

Sponsor: University of Arizona

  • Erin M Harvey, Ph.D., PRINCIPAL_INVESTIGATOR, University of Arizona
  • John D Twelker, O.D., Ph.D., PRINCIPAL_INVESTIGATOR, University of Arizona

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-25
Study Completion Date2027-02

Study Record Updates

Study Start Date2021-03-25
Study Completion Date2027-02

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Astigmatism Bilateral
  • Eyeglasses