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Dilated Versus Non-Dilated Wavefront Corrections for Patients With Down Syndrome

Dilated Wavefront Versus Non-Dilated Wavefront for Metric-Optimized Refraction Procedure for Individuals With Down Syndrome

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05059041
Enrollment
42
Registered
2021-09-28
Start date
2022-05-06
Completion date
2025-01-24
Last updated
2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Down Syndrome, Refractive Errors

Brief summary

Individuals with Down syndrome (DS) live with visual deficits due, in part, to elevated levels of higher-order optical aberrations (HOA). HOAs are distortions/abnormalities in the structure of the refractive components of the eye (i.e. the cornea and the lens) that, if present, can result in poor quality focus on the retina, thus negatively impacting vision. HOAs in the general population are overall low, and thus not ordinarily considered during the eye examination and determination of refractive correction. However, for some populations, such as individuals with DS, HOAs are elevated, and thus the commonly used clinical techniques to determine refractive corrections may fall short. The most common clinical technique for refractive correction determination is subjective refraction whereby a clinician asks the patient to compare different lens options and select the lens that provides the best visual outcome. Given the cognitive demands of the standard subjective refraction technique, clinicians rely on objective clinical techniques to prescribe optical corrections for individuals with DS. This is problematic, because it may result in errors for eyes with elevated HOA given that these techniques do not include measurement of the HOAs. The proposed research evaluates the use of objective wavefront measurements that quantify the HOAs of the eye as a basis for refractive correction determination for patients with DS. The specific aim is to determine whether dilation of the eyes is needed prior to objective wavefront measurements. Dilation of the eyes increases the ability to measure the optical quality of the eye and paralyzes accommodation (the natural focusing mechanism of the eye), which could be beneficial in determining refractions. However, the use of dilation lengthens the process for determining prescriptions and may be less desirable for patients.

Interventions

DEVICEDilated Refraction

The dilated refraction will be a trial spectacle frame composed of lenses based upon a spectacle prescription determined from dilated measures of the eye using a wavefront aberrometer.

DEVICENon-Dilated Refraction

The non-dilated refraction will be a trial spectacle frame composed of lenses based upon a spectacle prescription determined from non-dilated measures of the eye using a wavefront aberrometer.

Sponsors

Ohio State University
Lead SponsorOTHER
University of Houston
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Diagnosis of Down syndrome * Able to be dilated * Able to fixate for study measures * Able to respond for visual acuity testing

Exclusion criteria

* Ocular nystagmus * History of ocular or refractive surgery (strabismus surgery is okay) * Corneal or lenticular opacities * Ocular disease

Design outcomes

Primary

MeasureTime frameDescription
Distance Visual Acuity1 dayDistance (in LogMAR) visual acuity will be measured in the right eye with the British Standard Letter set or HOTV Matching for participants unable to name letters. Measurements will be obtained while the participant wears spectacle lenses based on their pre- and post-dilation refractions, respectively (from Visit 1). The order of testing is randomized. The primary outcome is the difference in distance visual acuity measurements calculated as visual acuity when wearing pre-dilation lens minus wearing post-dilation lens.

Secondary

MeasureTime frameDescription
Near Visual Acuity1 dayNear visual acuity (in logMAR) will be measured with a Bailey-Lovie style HOTV card. Measurements will be obtained while the participant wears spectacle lenses based on their pre- and post-dilation refractions, respectively (from Visit 1). The order of testing is randomized. The outcome of interest is the difference in near visual acuity measurements calculated as visual acuity when wearing pre-dilation lens minus wearing post-dilation lens.
Participant Rating of Distance Vision Quality1 dayParticipants will be asked to rate their quality of vision at near on a five-point scale where 1 will correspond to poorest vision and 5 will correspond to best vision. Ratings will be obtained at the end of testing with each spectacle lens (based on pre- and post-dilation refraction).
Participant Rating of Vision Quality at Near1 dayParticipants will be asked to rate their quality of vision at near on a five-point scale where 1 will correspond to poorest vision and 5 will correspond to best vision. Ratings will be obtained at the end of testing with each spectacle lens (based on pre- and post-dilation).
Participant Overall Preference for Prescriptions1 dayParticipants will be asked to select which of the two prescriptions (spectacles based on pre- or post-dilation) are preferred overall.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORHeather Anderson, OD, PhD

Ohio State University

Participant flow

Recruitment details

Children (n=21) and adults (n=21) were enrolled in the study.

Pre-assignment details

Visit 1: All participants had pre- and post-dilation measures taken to determine refractions. Visit 2: Participants randomized to a single session testing schedule of either 1) pre-dilation then post-dilation refractions; or 2) post-dilation then pre-dilation refractions. Randomization was completed within strata based on age cohort. All participants from Visit 1 returned for testing.

Baseline characteristics

Characteristic
Age, Continuous11.2 years
STANDARD_DEVIATION 3.7
Distance visual acuity (OD)0.41 logmar
STANDARD_DEVIATION 0.21
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
8 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Near visual acuity0.26 logMAR
STANDARD_DEVIATION 0.18
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
1 Participants
Race (NIH/OMB)
Black or African American
1 Participants
Race (NIH/OMB)
More than one race
3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
33 Participants
Sex: Female, Male
Female
4 Participants
Sex: Female, Male
Male
8 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 210 / 21
other
Total, other adverse events
0 / 210 / 21
serious
Total, serious adverse events
0 / 210 / 21

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026