24 Participants NeededMy employer runs this trial

Metric-Optimized Spectacles for Children With Down Syndrome

HA
Overseen ByHeather Anderson, OD, PhD
Age: < 18
Sex: Any
Trial Phase: Phase 2
Sponsor: Ohio State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether special glasses prescriptions, based on computer-analyzed eye images, can improve vision more effectively for children with Down syndrome than standard prescriptions. Two groups participate: one starts with the computer-optimized glasses (Metric-Optimized Spectacle Prescriptions) and then switches to the standard ones, while the other follows the reverse order. Children aged 5 to 12 with Down syndrome who can sit for eye exams and have their eyes dilated may be suitable for this study. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, offering a chance to advance vision care for children with Down syndrome.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that metric-optimized spectacle prescriptions are safe for children with Down syndrome?

Research has shown that glasses prescriptions created through computer analysis of detailed eye images are safe. Studies have found that these computer-generated prescriptions are well-tolerated. For instance, one study discovered that these prescriptions can provide vision clarity equal to or better than traditional prescriptions made by eye doctors. No major reports of problems have emerged from using this method. This suggests that this approach to prescribing glasses is generally safe and does not harm participants.12345

Why are researchers excited about this trial?

Metric-Optimized Spectacle Prescriptions for children with Down syndrome are unique because they tailor eyeglasses based on precise measurements rather than standard clinical prescriptions. Traditional treatments for vision issues in children with Down syndrome typically involve conventional spectacle prescriptions. However, the metric-optimized approach focuses on customizing the lens based on individual visual metrics, potentially improving visual acuity and comfort more effectively. Researchers are excited about this method as it could lead to better visual outcomes and quality of life for children with Down syndrome by addressing their specific vision needs more accurately.

What evidence suggests that metric-optimized spectacle prescriptions are effective for improving vision in children with Down syndrome?

Research has shown that special glasses designed using computer analysis of eye images might improve vision for people with Down syndrome. In this trial, participants will first receive either metric-optimized spectacle prescriptions or clinical spectacle prescriptions, switching after two months. One study found that adults with Down syndrome experienced clearer vision with these special glasses compared to regular ones. Another study suggested these glasses could help with common vision problems in people with Down syndrome. While more research is needed, these early results indicate that this approach could enhance vision quality.12567

Are You a Good Fit for This Trial?

This trial is for children aged 5 to 12 years who have Down syndrome, can sit still for eye tests, and are able to have their eyes dilated.

Inclusion Criteria

I am 5 to 12 years old with Down syndrome and can sit and have my eyes dilated.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day
1 visit (in-person)

Enrollment Exam

Participants undergo distance refraction measurement, pupil size measurement, and wavefront aberration measurement. A complete eye examination is performed.

1 day
1 visit (in-person)

Treatment

Participants receive spectacle prescriptions and undergo visual acuity and binocularity testing. Spectacles are dispensed in two-month intervals with a SmartButton data logger to assess wear time.

4 months
2 visits (in-person) at two-month intervals

Follow-up

Participants are monitored for visual acuity and binocularity improvements after 6 months of continued spectacle wear.

6 months
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Metric-Optimized Spectacle Prescriptions

Trial Overview

The study compares two ways of prescribing glasses: one uses detailed computer analysis of the eyes (metric-optimized), and the other uses standard clinical methods. The goal is to see which method gives better vision results.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Metric-Optimized First, Clinical SecondExperimental Treatment2 Interventions
Group II: Clinical First, Metric-Optimized SecondExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials
891
Recruited
2,659,000+

National Eye Institute (NEI)

Collaborator

Trials
572
Recruited
1,320,000+

Citations

Visual Acuity Outcomes in a Randomized Trial of Wavefront ...

This trial quantified visual acuity outcomes in adults with Down syndrome with spectacles dispensed for each of three refraction methods: standard clinical ...

Sources of reduced visual acuity and spectacle treatment ...

There is evidence that individuals with Down syndrome may benefit from bifocal lenses in childhood to optimise near visual acuity. PURPOSE. Down ...

Metric-Optimized Spectacle Prescriptions for Children With ...

This study seeks to determine whether glasses prescriptions determined from computer analysis of detailed images of the eyes provide better vision outcomes…

A Randomized Trial of Objective Spectacle Prescriptions for ...

Visual Acuity Outcomes in a Randomized Trial of Wavefront Metric-optimized Refractions in Adults with Down Syndrome · Vision Improvement in Keratoconus Patients ...

Metric-Optimized Spectacles for Children With Down ...

This study seeks to determine whether glasses prescriptions determined from computer analysis of detailed images of the eyes provide better ...

Spectacles for Patients with Down Syndrome

The purpose of this study is to test the hypothesis that metric-derived spectacle prescriptions based on.

A Randomized Trial of Objective Spectacle Prescriptions ...

This study is designed to compare the performance of spectacle prescriptions identified by the optimization of two separate image quality ...