Trial reportOphthalmology2019
A Randomized Clinical Trial of Immediate versus Delayed Glasses for Moderate Hyperopia in 1- and 2-Year-Olds.
Trial report in Ophthalmology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01515475 (Glasses Versus Observation for Moderate Hyperopia in Young Children), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Glasses Versus Observation for Moderate Hyperopia in Young Children (HTS1)
Who cites it
7 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.
- Spectacle correction versus no spectacles for prevention of strabismus in hyperopic children.The Cochrane database of systematic reviews · 2020Pooled it
- How Do Most Young Moderate Hyperopes Avoid Strabismus?Investigative ophthalmology & visual science · 2023Article
- Refractive prescribing for preschool children by optometrists in England.Ophthalmic & physiological optics : the journal of the British College of Ophthalmic Opticians (Optometrists) · 2023Article
- Effectiveness of routine population-wide orthoptic preschool vision screening tests at age 6-24 months in the Netherlands.Acta ophthalmologica · 2022Article
- Correction of Low-Moderate Hyperopia Improves Accommodative Function for Some Hyperopic Children During Sustained Near Work.Investigative ophthalmology & visual science · 2021Article
- Prevalence, Characteristics, and Risk Factors of Moderate or High Hyperopia among Multiethnic Children 6 to 72 Months of Age: A Pooled Analysis of Individual Participant Data.Ophthalmology · 2019Article
- Anisometropia in children: Current understanding and clinical implications.Taiwan journal of ophthalmologyReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 12 institutions in 2 countries.
Funding
Abstract
purposeTwo strategies were compared for managing moderate hyperopia without manifest strabismus among 1- and 2-year-old children: (1) immediate prescription of glasses versus (2) observation without glasses unless reduced distance visual acuity (VA), reduced stereoacuity, or manifest strabismus.
designProspective randomized clinical trial.
participantsA total of 130 children aged 1 to 2 years with hyperopia between +3.00 diopters (D) and +6.00 D spherical equivalent (SE) in at least 1 eye, anisometropia ≤1.50 D SE, and astigmatism ≤1.50 D based on cycloplegic refraction and no manifest strabismus.
methodsParticipants were randomly assigned to glasses (1.00 D less than full cycloplegic hyperopia) versus observation and followed every 6 months for 3 years. Glasses were prescribed to those assigned to observation if they met prespecified deterioration criteria of distance VA or near stereoacuity below age norms, or development of manifest strabismus.
main outcome measuresAt the 3-year primary outcome examination, participants were classified as failing the randomized management regimen if distance VA or stereoacuity was below age norms or manifest strabismus was observed (each with and without correction in trial frames, confirmed by masked retest, irrespective of whether deterioration had occurred previously), or if strabismus surgery had been performed.
resultsOf the 106 participants (82%) completing the 3-year primary outcome examination, failure occurred in 11 (21%) of 53 in the glasses group and 18 (34%) of 53 in the observation group (difference = -13%; 95% confidence interval [CI], -31 to 4; P = 0.14). Sixty-two percent (95% CI, 49-74) in the observation group and 34% (95% CI, 23-48) in the glasses group met deterioration criteria (requiring glasses if not wearing).
conclusionsFor 1- and 2-year-olds with uncorrected moderate hyperopia (+3.00 D to +6.00 D SE), our estimates of failure, after 3 years of 6-month follow-ups, are inconclusive and consistent with a small to moderate benefit or no benefit of immediate prescription of glasses compared with careful observation (with glasses only if deteriorated).
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