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

Down Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05059041
• Other study ID #: EY024590
• Status: Recruiting
• Phase: Phase 2
• Start date: May 6, 2022
• Est. completion date: January 31, 2024

Study information

• Verified date: June 2023
• Source: Ohio State University
• Contact: Heather Anderson, OD, PhD
• Phone: 614-247-5825
• Email: anderson.3881[@]osu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Down Syndrome
• Refractive Errors
• Syndrome

Intervention

Device:
• Dilated 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.
• Non-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.

Locations

Country	Name	City	State
United States	Ohio State University	Columbus	Ohio
United States	University of Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	University of Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance Visual Acuity	Distance LogMAR visual acuity will be measured with the British Standard Letter set or HOTV Matching for participants unable to name letters	1 day
Secondary	Near Visual Acuity	Near LogMAR visual acuity will be measured with a Bailey-Lovie style HOTV card.	1 day
Secondary	Participant distance vision ranking	Participants will be asked rate quality of vision at distance on a five point scale for each prescription. 1 will correspond to poorest vision and 5 will correspond to best vision.	1 day
Secondary	Participant near vision ranking	Participants will be asked rate quality of vision at near on a five point scale for each prescription. 1 will correspond to poorest vision and 5 will correspond to best vision.	1 day
Secondary	Participant overall preference for prescriptions	Participants will be asked to select which of two prescriptions are preferred overall.	1 day