Draft Research Plan
Vision in Children Ages 6 Months to 5 Years: Screening
April 24, 2025
Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.
This document is available for Public Comments until May 21, 2025 11:59 PM EDT
In an effort to maintain a high level of transparency in our methods, we open our Draft Research Plan to a public comment period before we publish the final version.
Leave a Comment >>a Amblyopia risk factors include anisometropia, strabismus, hyperopia, any media opacity, astigmatism, and abnormal visual acuity (which includes substantial isoametropic refractive error).
b Determination of refractive error will be based on age-appropriate standards.
1. Does screening for amblyopia, its risk factors, and refractive error in children ages 6 months to 5 years reduce long-term amblyopia, improve visual acuity in childhood and/or adulthood, or improve school performance, functioning, and/or quality of life?
2. What is the accuracy and reliability of screening tests for amblyopia, its risk factors, and refractive error in children ages 6 months to 5 years?
3. What are the harms of screening for amblyopia, its risk factors, and refractive error in children ages 6 months to 5 years?
4a. Does treatment of amblyopia, its risk factors, and refractive error in children ages 6 months to 5 years improve visual acuity in childhood and/or adulthood?
4b. Does treatment of amblyopia, its risk factors, and refractive error in children ages 6 months to 5 years reduce long-term amblyopia or improve school performance, functioning, and/or quality of life?
5. What are the harms of treatment of amblyopia, its risk factors, and refractive error in children ages 6 months to 5 years?
Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.
- What are the current rates of completion of eye examinations and obtaining appropriate treatment for amblyopia, its risk factors, or refractive error among children with screen-identified vision concerns?
- How do rates of completion of eye examinations and obtaining appropriate treatment for amblyopia, its risk factors, or refractive error among children with screen-identified vision concerns vary based on patient characteristics?
To the extent possible, we plan to describe the population, screening modality, and intervention characteristics of the included studies, as appropriate for each Key Question. Data on population characteristics will help us explore the degree to which the findings are representative of all children as well as investigate potential differences in benefits and harms by different population groups.
The proposed Research Approach identifies the study characteristics and criteria that the Evidence-based Practice Center will use to search for publications and to determine whether identified studies should be included or excluded from the Evidence Review. Criteria are overarching as well as specific to each of the Key Questions.
| Include | Exclude | |
|---|---|---|
| Populations | All KQs: Children ages 6 months to 5 years
KQs 1–3: Children without known impaired visual acuity or obvious symptoms of impaired visual acuity KQs 4, 5: Children with amblyopia, amblyogenic risk factors, and/or refractive error |
Newborns, children younger than age 6 months, and children age 6 years or older; cchildren with a history of retinopathy of prematurity, glaucoma, congenital cataract, systemic conditions associated with ocular abnormalities, or pathologic myopia
Studies evaluating screening in specified populations of children with a chronic medical or developmental condition will also be excluded |
| Setting | All KQs: Studies performed in primary care, community-based, and school settings; studies conducted in countries categorized as “Very High” on the Human Development Index, as defined by the United Nations Development Programme
KQs 2–5: Specialty settings (e.g., ophthalmology or optometry practices) |
|
| Screening tests and interventions | KQs 1–3: Studies of screening tests used or available in primary care settings, including: visual acuity tests (e.g., autorefraction; picture identification tests, such as Allen test cards or Lea symbols; HOTV chart; Snellen chart; stereoacuity tests (e.g., contour stereotests, such as the Frisby, Random Dot E, Stereo Smile, and Titmus Fly tests; Moving Dynamic Random Dot Stereosize test); and ocular alignment tests (e.g., corneal light reflex test, pupillary reflex test, cover-uncover test, cross cover test, red reflex test)
Studies assessing photoscreeners for screening will be included if the photoscreener being evaluated is in current use KQs 4, 5:Correction of refractive error (eyeglasses, corrective lenses, and low-dose atropine); penalization of the nonamblyogenic eye (eye patch, atropine); vision therapy (eye exercises) |
KQs 1–3: Studies of screening tests not used or available in primary care settings (e.g., contrast sensitivity test, fundoscopic examination, visual acuity test with cyclopegia) or not intended to detect amblyopia, amblyogenic risk factors, or refractive error (e.g., white reflex test)
KQs 2, 3: Studies exclusively assessing photoscreeners not in current use will be excluded (e.g., MTI photoscreener, VisiScreen 100 photoscreener, Otago [noncommercial] photoscreener, off-axis-type photoscreener, Topcon PR2000) KQs 4, 5: Surgical interventions for strabismus or other indications; acupuncture |
| Comparisons | KQs 1,3: Screened vs. nonscreened groups or earlier (at a younger age) vs. later screening (at an older age)
KQ 2: Evaluations that include cycloplegic refraction and/or a comprehensive eye examination; for evaluations of reliability (test-retest), the comparison may be the same test administered at different timepoints or by a different person KQs 4, 5: No treatment or sham or inactive control |
No comparison; nonconcordant historical controls; comparative studies of various interventions (i.e., head-to-head studies without an additional eligible comparison group) |
| Outcomes | KQs 1, 4: Reduced long-term amblyopia and improved visual acuity, school performance, functioning, and quality of life
KQ 2: Sensitivity, specificity, positive and negative predictive values, likelihood ratios, and diagnostic odds ratios (or ability to calculate such outcomes from data provided); measures of reliability, including reproducibility, interrater reliability, and testability (ability of children to cooperate with the test) KQs 3, 5: Harms, including psychological distress, labeling, anxiety, other psychological effects, false-positive results, and adverse effects on vision in the nonimpaired eye |
Cost-effectiveness or cost-related outcomes
KQ 2: Studies only providing associations, correlations, or other outcomes |
| Study designs | KQ 1: Randomized, controlled trials and prospective cohort studies with an eligible comparator
KQ 2: Cross-sectional studies, cohort studies, or trials focused on assessment of diagnostic accuracy KQs 3, 5: Randomized, controlled trials; controlled cohort studies; case-control studies KQ 4: Randomized, controlled trials |
Case reports, case series, systematic reviews, and all other study designs not listed as eligible; systematic reviews containing potentially relevant studies will be hand-searched for eligible articles
KQ 2: Studies that do not attempt to perform the reference standard in all participants or a random sample of participants |
| Language and Publication status | English-language, full-text journal articles | Languages other than English; publications available only as a conference abstract |