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| Name | Class |
|---|---|
| University of Houston | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dilated Refraction | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heather Anderson, OD, PhD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University | Columbus | Ohio | 43210 | United States | ||
| University of Houston |
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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.
Children (n=21) and adults (n=21) were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adults - Spectacle Testing Order: Pre-dilation Refraction Then Post-dilation Refraction | Participants aged 18 to 52 years with Down Syndrome tested in spectacles based on pre-dilation refraction then spectacles based on post-dilation refraction. All testing occurred during one study visit. |
| FG001 | Adults - Spectacle Testing Order: Post-dilation Refraction Then Pre-dilation Refraction | Participants aged 18 to 52 years with Down Syndrome tested in spectacles based on post-dilation refraction then spectacles based on pre-dilation refraction. All testing occurred during one study visit. |
| FG002 | Youth - Spectacle Testing Order: Pre-dilation Refraction Then Post-dilation Refraction | Participants aged 5 to 17 years with Down Syndrome tested in spectacles based on pre-dilation refraction then spectacles based on post-dilation refraction. All testing occurred during one study visit. |
| FG003 | Youth - Spectacle Testing Order: Post-dilation Refraction Then Pre-dilation Refraction | Participants aged 5 to 17 years with Down Syndrome tested in spectacles based on post-dilation refraction then spectacles based on pre-dilation refraction. All testing occurred during one study visit. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adults - Spectacle Testing Order: Pre-dilation Refraction Then Post-dilation Refraction | Participants aged 18 to 52 years with Down Syndrome tested in spectacles based on pre-dilation refraction then spectacles based on post-dilation refraction. All testing occurred during one study visit. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age measured in years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants aged 5 to 52 that were enrolled and subsequently randomized to a testing order. | Posted | Mean | 95% Confidence Interval | logMAR | 1 day |
|
Study occurred over a single visit for each participant, so adverse event data was collected over 1 day.
There were no differences from the way adverse events are defined by clinical trials gov.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DS Adults | Participants ages 18 to 52 years with Down Syndrome | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather Anderson | The Ohio State University | 614-247-5825 | anderson.3881@osu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 15, 2021 | Nov 7, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004314 | Down Syndrome |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Non-Dilated Refraction | Device | 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. |
|
| 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). | 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). | 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. | 1 day |
| Houston |
| Texas |
| 77004 |
| United States |
| Adults - Spectacle Testing Order: Post-dilation Refraction Then Pre-dilation Refraction |
Participants aged 18 to 52 years with Down Syndrome tested in spectacles based on post-dilation refraction then spectacles based on pre-dilation refraction. All testing occurred during one study visit. |
| BG002 | Youth - Spectacle Testing Order: Pre-dilation Refraction Then Post-dilation Refraction | Participants aged 5 to 17 years with Down Syndrome tested in spectacles based on pre-dilation refraction then spectacles based on post-dilation refraction. All testing occurred during one study visit. |
| BG003 | Youth - Spectacle Testing Order: Post-dilation Refraction Then Pre-dilation Refraction | Participants aged 5 to 17 years with Down Syndrome tested in spectacles based on post-dilation refraction then spectacles based on pre-dilation refraction. All testing occurred during one study visit. |
| BG004 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Distance visual acuity (OD) | Distance LogMAR visual acuity measured with the British Standard Letter set or HOTV Matching for participants unable to name letters. | Mean | Standard Deviation | logmar |
|
| Near visual acuity | Near LogMAR visual acuity measured with a Bailey-Lovie style HOTV card. | Could not test near visual acuity on 5 youth participants | Mean | Standard Deviation | logMAR |
|
| OG001 | Adults: Post-dilation Refraction | Participants aged 18 to 57 with Down Syndrome wearing spectacles based on their post-dilation refraction regardless of test order (worn first or second) |
| OG002 | Youth: Pre-dilation Refraction | Participants aged 5 to 17 with Down Syndrome wearing spectacles based on their pre-dilation refraction regardless of test order (worn first or second) |
| OG003 | Youth: Post-dilation Refraction | Participants aged 5 to 17 with Down Syndrome wearing spectacles based on their post-dilation refraction regardless of test order (worn first or second) |
|
|
|
| Secondary | 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. | All participants aged 5 to 52 enrolled and subsequently randomized to a testing order. For statistical testing, the participant must have visual acuity data from testing with pre- and post-dilation (i.e. n=20 adults). | Posted | Mean | 95% Confidence Interval | logMAR | 1 day |
|
|
|
|
| Secondary | 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). | All participants aged 5 to 52 that were enrolled and subsequently randomized to a testing order. Responses could not be obtained from 2 youths because of communication issues. | Posted | Median | Inter-Quartile Range | score on a scale | 1 day |
|
|
|
|
| Secondary | 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). | All participants aged 5 to 52 that were enrolled and subsequently randomized to a testing order. | Posted | Median | Inter-Quartile Range | score on a scale | 1 day |
|
|
|
|
| Secondary | 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. | All participants aged 5 to 52 that were enrolled and subsequently randomized to a testing order. | Posted | Count of Participants | Participants | 1 day |
|
|
|
|
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | DS Youth | Participants ages 5 to 17 years with Down Syndrome | 0 | 21 | 0 | 21 | 0 | 21 |
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| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D005128 | Eye Diseases |
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Superiority |
| The null hypothesis is that dilation does not impact visual acuity in youth with Down Syndrome. Since this is a cross-over study, each participant is measured pre- and post-dilation and the null hypothesis test can be re-written as a comparison of the mean difference to zero. | paired t-test | Alpha = 0.05 assuming a two-sided hypothesis. t-statistic = 0.698, df = 19 | 0.49 | Sample size of 20 equates to 80% power to detect a difference of 0.086 logMAR (approximately 4 letters) | Mean difference in near visual acuity | 0.020 | Standard Deviation | 0.128 | 2-Sided | 95 | -0.040 | 0.080 | The null hypothesis is the mean difference is zero. Difference calculated as distance VA while wearing glasses based on non-cycloplegic refraction minus that while wearing glasses based on cycloplegic refraction. | Superiority |
| Superiority |
| The null hypothesis is that the rating of vision quality after wearing lens from pre-dilation refraction equals the rating from post-dilation refraction. Each participant rates vision quality for each condition (pre- and post-dilation) so the null hypothesis can be re-written as a comparison of the mean/median difference to zero. The response options (1 to 5) are ordinal so a Wilcoxon sign rank test is used to address the null hypothesis with alpha = 0.05 assuming a 2-sided hypothesis. | Wilcoxon sign rank | S-statistic = 0 | > 0.99 | Median Difference (Final Values) | 0.0 | The difference in rating scale scores was calculated as the score after wearing lens based on pre-dilation refraction minus that based on post-dilation refraction. | Superiority |
| Superiority |
| The null hypothesis is that the rating of vision quality at near after wearing lens from pre-dilation refraction equals the rating from post-dilation refraction. Each participant rates vision quality for each condition (pre- and post-dilation) so the null hypothesis can be re-written as a comparison of the median difference to zero. The response options (1 to 5) are ordinal so a Wilcoxon sign rank test is used to address the null hypothesis with alpha = 0.05 assuming a 2-sided hypothesis. | Wilcoxon sign rank | S-statistics = -5.5 | 0.34 | Median Difference (Final Values) | 0.0 | The difference in rating scale scores was calculated as the score after wearing lens based on pre-dilation refraction minus that based on post-dilation refraction. | Superiority |
| Prefer post-dilation prescription |
|
| No preference |
|
This percentage was compared to 50% (no preference)
| Superiority |
| Null hypothesis: proportion who prefer dilated = proportion that prefer non-dilated = 0.50. Any participant who responded "No preference" will be excluded from the analysis as they do not inform the statistical analysis of anything about preference decision (pre- OR post-dilation spectacles). This will be tested using a chi-square test with 1 degree of freedom, alpha = 0.05 and assuming a two-sided test is desired. | Chi-squared | 0.49 | Power calculations were completed testing the hypothesis of equal proportions (i.e. = 0.50). A sample size of 19 equates to 83% power if we assume that the actual proportion is 0.80. | % preferred pre-dilation spectacles | 57.9 | Standard Deviation | 11.3 | 2-Sided | 95 | 36.3 | 79.5 | This percentage was compared to 50% (no difference) | Superiority |