Dilated Versus Non-Dilated Wavefront Corrections for Patients With Down Syndrome
Primary Purpose
Down Syndrome, Refractive Errors
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dilated Refraction
Non-Dilated Refraction
Sponsored by
About this trial
This is an interventional treatment trial for Down Syndrome
Eligibility Criteria
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
Sites / Locations
- Ohio State UniversityRecruiting
- University of HoustonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dilated first, non-dilated second
Non-dilated first, dilated second
Arm Description
Each participant will perform vision testing first through a prescription determined from wavefront measurements obtained after dilation. Second, each participation will perform vision testing through a prescription determined from wavefront measurements obtained before dilation.
Each participant will perform vision testing first through a prescription determined from wavefront measurements obtained before dilation. Second, each participation will perform vision testing through a prescription determined from wavefront measurements obtained after dilation.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Near Visual Acuity
Near LogMAR visual acuity will be measured with a Bailey-Lovie style HOTV card.
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.
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.
Participant overall preference for prescriptions
Participants will be asked to select which of two prescriptions are preferred overall.
Full Information
NCT ID
NCT05059041
First Posted
September 17, 2021
Last Updated
June 26, 2023
Sponsor
Ohio State University
Collaborators
University of Houston
1. Study Identification
Unique Protocol Identification Number
NCT05059041
Brief Title
Dilated Versus Non-Dilated Wavefront Corrections for Patients With Down Syndrome
Official Title
Dilated Wavefront Versus Non-Dilated Wavefront for Metric-Optimized Refraction Procedure for Individuals With Down Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 6, 2022 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
University of Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome, Refractive Errors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dilated first, non-dilated second
Arm Type
Experimental
Arm Description
Each participant will perform vision testing first through a prescription determined from wavefront measurements obtained after dilation. Second, each participation will perform vision testing through a prescription determined from wavefront measurements obtained before dilation.
Arm Title
Non-dilated first, dilated second
Arm Type
Experimental
Arm Description
Each participant will perform vision testing first through a prescription determined from wavefront measurements obtained before dilation. Second, each participation will perform vision testing through a prescription determined from wavefront measurements obtained after dilation.
Intervention Type
Device
Intervention Name(s)
Dilated Refraction
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Non-Dilated Refraction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Distance Visual Acuity
Description
Distance LogMAR visual acuity will be measured with the British Standard Letter set or HOTV Matching for participants unable to name letters
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Near Visual Acuity
Description
Near LogMAR visual acuity will be measured with a Bailey-Lovie style HOTV card.
Time Frame
1 day
Title
Participant distance vision ranking
Description
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.
Time Frame
1 day
Title
Participant near vision ranking
Description
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.
Time Frame
1 day
Title
Participant overall preference for prescriptions
Description
Participants will be asked to select which of two prescriptions are preferred overall.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heather Anderson, OD, PhD
Phone
614-247-5825
Email
anderson.3881@osu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Anderson, OD, PhD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Anderson, OD, PhD
Phone
614-247-5825
Email
anderson.3881@osu.edu
Facility Name
University of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Marsack, PhD
Phone
713-743-0661
Email
jdmarsac@central.uh.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Dilated Versus Non-Dilated Wavefront Corrections for Patients With Down Syndrome
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