Health TrialsbyHealthPanel

The Emmetropization Via Accommodation (EVA) - II Study

ConditionsHyperopiaFarsightednessHypermetropia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-19
SponsorOhio State University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Astigmatism >2.00 D in either eye.

Anisometropia >1.50 D spherical equivalent.

Strabismus.

Previous difficulty with pupil dilation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Experimental treatment arm

    Combination product

    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.

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: ObservationNo intervention 0 interventions
Group B: Spectacles and At-Home TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Ocular Accommodation measured with MEM

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

Time frame
14 months

Secondary outcomes

1

Correlation between refractive error and ocular accommodation measured with MEM

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

Time frame
14 months
2

Correlation between refractive error and ocular accommodation measured with PowerRefractor

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

Time frame
14 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: