Health TrialsbyHealthPanel

Metric-Optimized Spectacle Prescriptions for Children With Down Syndrome

ConditionsRefractive Error CorrectionVisual Acuity
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age5-12
SponsorOhio State University

About this trial

This study seeks to determine whether glasses prescriptions determined from computer analysis of detailed images of the eyes provide better vision outcomes for children with Down syndrome than prescriptions determined using routine clinical methods.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Down syndrome

Age 5 to 12 years

Ability to sit for study measures

Able to be dilated

Disqualifiers

Nystagmus

History of Ocular or Refractive Surgery

Corneal or lenticular opacities

Ocular disease

Trial design

Design model

Crossover

Treatments tested in this trial

  • Metric-optimized spectacles

    Device

    Metric-optimized spectacles are glasses made from a prescription determined by the optimization of a metric for retinal image quality, Visual Strehl Ratio (VSX), as determined by algorithms utilizing wavefront aberration measures of the eye

  • Routine Clinical Spectacles

    Device

    Routine clinical spectacles are glasses made from a prescription based upon findings that are obtained during a routine eye examination, including autorefraction measures.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Metric-Optimized First, Clinical SecondExperimental treatment 2 interventions
Group B: Clinical First, Metric-Optimized SecondExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Adapted Distance Visual Acuity

Aided LogMAR (minimum angle of resolution) distance visual acuity obtained with either British Standard Letters or HOTV - matching for participants unable to name letters

Time frame
2 months

Secondary outcomes

1

Initial Distance Visual Acuity

Aided LogMAR (minimal angle of resolution) distance visual acuity obtained with either British Standard Letters or HOTV - matching for participants unable to name letters

Time frame
1 day
2

Near Visual Acuity

Near LogMAR (minimum angle of resolution) visual acuity will be measured with a Bailey-Lovie style HOTV card

Time frame
2 months
3

Spectacle Wear Time

Total wear time of each pair of spectacles as measured objectively by a temperature sensor data logger mounted to the spectacle temple

Time frame
2 months
4

Participant Survey

Four question custom written survey with each question rated on a 5 point frown to smile scale. Questions target whether the subject likes the spectacles, feels they have good vision at distance and near, and feels that they see better with the spectacles than without. The lowest score is 1 and the highest score is 5 with 5 indicating better vision and higher preference for spectacles.

Time frame
2 months

Other outcomes

Sponsors and contacts

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

Ohio State University

Lead sponsor

National Eye Institute (NEI)

Collaborator

Source ClinicalTrials.gov
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