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The Emmetropization Via Accommodation (EVA) - II Study (EVA-II)

17. september 2026 oppdatert av: Ohio State University

To determine if wearing a novel treatment during a 15-month period will enhance emmetropization in 4-month-old infants who have demonstrated poor ocular accommodation (eye focusing).

Studieoversikt

Status

Har ikke rekruttert ennå

Detaljert beskrivelse

Uncorrected hyperopia (farsightedness) in children can lead to significant learning and visual problems, affecting their overall well-being and academic potential. Normally, infants are born with a moderate degree of hyperopia which should decrease as undergo a normal, developmental process called emmetropization, which mostly occurs during the first 18 months of life. Sometimes, this process fails, leaving children with higher-than-normal levels of hyperopia, which significantly increases their risk of developing conditions like strabismus (crossed eyes), amblyopia (lazy eye), and early literacy and scholastic issues. Infants who are at the greatest risk of not undergoing the normal emmetropization process are those with significantly higher levels of hyperopia early in infancy and those with poor ocular accommodation. The emmetropization process is not perfectly understood in human infants but may allow a window of opportunity for early intervention to help reduce the risk of debilitating vision conditions, while the visual system is still plastic. This study seeks to determine if early intervention, specifically partial refractive correction and visual engagement exercises (meant to stimulate ocular accommodation), can help improve the accommodative response and therefore reduce hyperopia in infants at high risk of not undergoing emmetropization. By treating 4-month-old infants with poor accommodation, the study aims to facilitate emmetropization and potentially reduce the risk of long-term visual problems. The study will also explore whether hyperopic defocus or accommodative effort is the primary signal guiding emmetropization, the two major theories of human emmetropization. Positive outcomes from this research could lead to new standards of care for hyperopic infants, potentially preventing a lifetime of vision-related issues and improving early literacy and academic performance.

Studietype

Intervensjonell

Registrering (Antatt)

52

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

    • Ohio
      • Columbus, Ohio, Forente stater, 43209
        • The Ohio State University College of Optometry
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

2 måneder til 4 måneder (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Signed parental permission and HIPAA authorization and willingness to comply with study procedures.
  • Infant 13-19 weeks of age at baseline.
  • Either sex and any race or ethnicity.
  • Good general health based on parent-provided history, normal pregnancy and delivery without serious complications, and birthweight >2500 g.
  • Mean MEM accommodative lag >+1.25 D based on three measurements throughout the baseline examination.
  • Cycloplegic spherical-equivalent hyperopia ≥+3.50 D in one or both eyes.

Exclusion Criteria:

  • Astigmatism >2.00 D in either eye.
  • Anisometropia >1.50 D spherical equivalent.
  • Strabismus.
  • Previous difficulty with pupil dilation.
  • Cardiac, liver, asthma, or other respiratory disease.
  • Ocular disease/abnormality, prior intraocular surgery, retinal detachment, optic nerve hypoplasia, malformation of the eye, cortical visual impairment, or active ocular inflammation.
  • Hydrocephalus, Down syndrome, cerebral palsy, severe developmental delay, or seizure disorder.
  • A condition preventing spectacle wear for the study duration (e.g., plagiocephaly).

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Observation

No treatment is administered in this arm.

Eksperimentell: Spectacles and At-Home Therapy

Participants will receive experimental treatment.

Infants will receive spectacles that have a prescription relative to the spherical equivalent in each eye as measured by the cycloplegic retinoscopy performed at baseline. Changes in spectacle lens power will be made as needed at follow-up visits to keep the level of under-correction within 0.50D from the study protocol. An experimental non-invasive treatment will be prescribed as well. Treatment will continue until study completion at 18 months of age or until the infant reaches a spherical equivalent refractive error of +2.00D or less hyperopia. Participants will also receive a non-invasive treatment to be used at home.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Ocular Accommodation measured with MEM
Tidsramme: 14 months

Change in accommodative lag (in Diopters), measured with Monocular Estimation Method (MEM).

14 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Correlation between refractive error and ocular accommodation measured with MEM
Tidsramme: 14 months

Refractive error will be measured using retinoscopy, in Diopters (D) and ocular accommodation will be measured with MEM retinoscopy, in Diopters (D)

14 months
Correlation between refractive error and ocular accommodation measured with PowerRefractor
Tidsramme: 14 months

Refractive error will be measured using retinoscopy, in Diopters (D) and ocular accommodation will be measured with the PlusOptix PowerRefractor, in Diopters (D)

14 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. april 2027

Primær fullføring (Antatt)

30. juni 2031

Studiet fullført (Antatt)

30. juni 2032

Datoer for studieregistrering

Først innsendt

25. august 2026

Først innsendt som oppfylte QC-kriteriene

17. september 2026

Først lagt ut (Faktiske)

24. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 20261737

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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