Down SyndromePhase 2NCT05059041
Dilated Versus Non-Dilated Wavefront Corrections for Patients With Down Syndrome
A Phase 2 study testing Dilated Refraction and Non-Dilated Refraction in people with Down Syndrome and Refractive Errors, run by Ohio State University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Down Syndrome, Refractive Errors
- What is being tested?
- Dilated Refraction and Non-Dilated Refraction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 May 2022to 24 Jan 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of Down syndrome
- Able to be dilated
- Able to fixate for study measures
- Able to respond for visual acuity testing
Who cannot join
- Ocular nystagmus
- History of ocular or refractive surgery (strabismus surgery is okay)
- Corneal or lenticular opacities
- Ocular disease
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ohio State University
Columbus, Ohio, 43210
University of Houston
Houston, Texas, 77004
About this study
Official title: Dilated Wavefront Versus Non-Dilated Wavefront for Metric-Optimized Refraction Procedure for Individuals With Down Syndrome
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.
- Conditions
- Down Syndrome, Refractive Errors
- Being tested
- Dilated Refraction, Non-Dilated Refraction
- Medical subject headings
- Down Syndrome, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dilated RefractionDevice
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 RefractionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Dilated first, non-dilated second | Experimental | 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. Receives: Device: Dilated Refraction; Device: Non-Dilated Refraction |
| Non-dilated first, dilated second | Experimental | 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. Receives: Device: Dilated Refraction; Device: Non-Dilated Refraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance Visual Acuity
Distance (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.
Measured: 1 day
Secondary outcomes (4)
Near Visual Acuity
Near 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.
Measured: 1 day
Participant Rating of Distance Vision Quality
Participants 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).
Measured: 1 day
Participant Rating of Vision Quality at Near
Participants 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).
Measured: 1 day
Participant Overall Preference for Prescriptions
Participants will be asked to select which of the two prescriptions (spectacles based on pre- or post-dilation) are preferred overall.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start6 May 2022
- Primary completion24 Jan 2025
- Study completion24 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Houston
- Responsible party
- Principal investigator, Heather Anderson OD, PhD, Ohio State University
- Investigators
- Heather Anderson, OD, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059041
- Sponsor's protocol ID
- EY024590
- Status last verified
- Apr 2026
- First submitted
- 17 Sep 2021
- Last updated
- 8 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dilated Wavefront Versus Non-Dilated Wavefront for Metric-Optimized Refraction Procedure for Individuals With Down Syndrome
- ClinicalTrials.gov ID
- NCT05059041
- Acronym / sponsor ID
- EY024590
- Conditions
- Down Syndrome, Refractive Errors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- University of Houston
- Study start
- 6 May 2022 (actual)
- Primary completion
- 24 Jan 2025 (actual)
- Study completion
- 24 Jan 2025 (actual)
- First posted
- 28 Sep 2021 (actual)
- Results
- Posted 9 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dilated first, non-dilated second | Experimental | Device: Dilated Refraction, Device: Non-Dilated RefractionEach 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. |
| Non-dilated first, dilated second | Experimental | Device: Dilated Refraction, Device: Non-Dilated RefractionEach 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. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of Down syndrome
- Able to be dilated
- Able to fixate for study measures
- Able to respond for visual acuity testing
Key exclusion criteria (4 listed)
- Ocular nystagmus
- History of ocular or refractive surgery (strabismus surgery is okay)
- Corneal or lenticular opacities
- Ocular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dilated RefractionThe 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. | Device | Dilated first, non-dilated second, Non-dilated first, dilated second |
| Non-Dilated RefractionThe 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. | Device | Dilated first, non-dilated second, Non-dilated first, dilated second |
Primary outcome
Distance Visual Acuity
Time frame: 1 day
Distance (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.
4 secondary outcomes
Near Visual Acuity
Time frame: 1 day
Participant Rating of Distance Vision Quality
Time frame: 1 day
Participant Rating of Vision Quality at Near
Time frame: 1 day
Participant Overall Preference for Prescriptions
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Anderson, OD, PhD principal investigator
Ohio State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dilated Refraction and Non-Dilated Refraction in people with Down Syndrome and Refractive Errors, run by Ohio State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance Visual Acuity (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.