Trial Outcomes & Findings for Dilated Versus Non-Dilated Wavefront Corrections for Patients With Down Syndrome (NCT NCT05059041)
NCT ID: NCT05059041
Last Updated: 2026-05-08
Results Overview
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.
COMPLETED
PHASE2
42 participants
1 day
2026-05-08
Participant Flow
Children (n=21) and adults (n=21) were enrolled in the study.
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
7
|
13
|
8
|
|
Overall Study
COMPLETED
|
14
|
7
|
13
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Could not test near visual acuity on 5 youth participants
Baseline characteristics by cohort
| Measure |
Adults - Spectacle Testing Order: Pre-dilation Refraction Then Post-dilation Refraction
n=14 Participants
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.
|
Adults - Spectacle Testing Order: Post-dilation Refraction Then Pre-dilation Refraction
n=7 Participants
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.
|
Youth - Spectacle Testing Order: Pre-dilation Refraction Then Post-dilation Refraction
n=13 Participants
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.
|
Youth - Spectacle Testing Order: Post-dilation Refraction Then Pre-dilation Refraction
n=8 Participants
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.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
29.7 years
STANDARD_DEVIATION 9.1 • n=14 Participants
|
33.9 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
11.2 years
STANDARD_DEVIATION 3.7 • n=13 Participants
|
11.6 years
STANDARD_DEVIATION 3.7 • n=8 Participants
|
21.2 years
STANDARD_DEVIATION 12.1 • n=42 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=14 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=13 Participants
|
5 Participants
n=8 Participants
|
23 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=14 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=13 Participants
|
3 Participants
n=8 Participants
|
19 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=14 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=13 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=14 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=14 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=13 Participants
|
7 Participants
n=8 Participants
|
33 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=14 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=14 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=8 Participants
|
6 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=14 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=13 Participants
|
8 Participants
n=8 Participants
|
36 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=42 Participants
|
|
Distance visual acuity (OD)
|
0.41 logmar
STANDARD_DEVIATION 0.21 • n=14 Participants
|
0.38 logmar
STANDARD_DEVIATION 0.11 • n=7 Participants
|
0.51 logmar
STANDARD_DEVIATION 0.22 • n=13 Participants
|
0.41 logmar
STANDARD_DEVIATION 0.12 • n=8 Participants
|
0.43 logmar
STANDARD_DEVIATION 0.19 • n=42 Participants
|
|
Near visual acuity
|
0.27 logMAR
STANDARD_DEVIATION 0.24 • n=14 Participants • Could not test near visual acuity on 5 youth participants
|
0.26 logMAR
STANDARD_DEVIATION 0.18 • n=7 Participants • Could not test near visual acuity on 5 youth participants
|
0.40 logMAR
STANDARD_DEVIATION 0.29 • n=8 Participants • Could not test near visual acuity on 5 youth participants
|
0.41 logMAR
STANDARD_DEVIATION 0.14 • n=8 Participants • Could not test near visual acuity on 5 youth participants
|
0.33 logMAR
STANDARD_DEVIATION 0.23 • n=37 Participants • Could not test near visual acuity on 5 youth participants
|
PRIMARY outcome
Timeframe: 1 dayPopulation: All participants aged 5 to 52 that were enrolled and subsequently randomized to a testing order.
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.
Outcome measures
| Measure |
Youth: Post-dilation Ratings
n=21 Participants
Participants ages 5 to 17 years with Down Syndrome rating of vision quality at distance while wearing spectacles based on their pre-dilation refraction regardless of test order (worn first or second)
|
Adults: Pre-dilation Ratings
n=21 Participants
Participants ages 18 to 52 years with Down Syndrome rating of vision quality at near while wearing spectacles based on their pre-dilation refraction regardless of test order (worn first or second)
|
Adults: Post-dilation Ratings
n=21 Participants
Participants ages 18 to 52 years with Down Syndrome rating of vision quality at near while wearing spectacles based on their post-dilation refraction regardless of test order (worn first or second)
|
Youth: Pre-dilation Ratings
n=21 Participants
Participants ages 5 to 17 years with Down Syndrome rating of vision quality at near while wearing spectacles based on their pre-dilation refraction regardless of test order (worn first or second)
|
|---|---|---|---|---|
|
Distance Visual Acuity
|
0.43 logMAR
Interval 0.39 to 0.48
|
0.41 logMAR
Interval 0.32 to 0.5
|
0.41 logMAR
Interval 0.32 to 0.49
|
0.40 logMAR
Interval 0.34 to 0.47
|
SECONDARY outcome
Timeframe: 1 dayPopulation: 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).
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.
Outcome measures
| Measure |
Youth: Post-dilation Ratings
n=20 Participants
Participants ages 5 to 17 years with Down Syndrome rating of vision quality at distance while wearing spectacles based on their pre-dilation refraction regardless of test order (worn first or second)
|
Adults: Pre-dilation Ratings
n=20 Participants
Participants ages 18 to 52 years with Down Syndrome rating of vision quality at near while wearing spectacles based on their pre-dilation refraction regardless of test order (worn first or second)
|
Adults: Post-dilation Ratings
n=21 Participants
Participants ages 18 to 52 years with Down Syndrome rating of vision quality at near while wearing spectacles based on their post-dilation refraction regardless of test order (worn first or second)
|
Youth: Pre-dilation Ratings
n=20 Participants
Participants ages 5 to 17 years with Down Syndrome rating of vision quality at near while wearing spectacles based on their pre-dilation refraction regardless of test order (worn first or second)
|
|---|---|---|---|---|
|
Near Visual Acuity
|
0.38 logMAR
Interval 0.25 to 0.5
|
0.27 logMAR
Interval 0.18 to 0.36
|
0.28 logMAR
Interval 0.19 to 0.37
|
0.40 logMAR
Interval 0.28 to 0.51
|
SECONDARY outcome
Timeframe: 1 dayPopulation: 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.
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).
Outcome measures
| Measure |
Youth: Post-dilation Ratings
n=19 Participants
Participants ages 5 to 17 years with Down Syndrome rating of vision quality at distance while wearing spectacles based on their pre-dilation refraction regardless of test order (worn first or second)
|
Adults: Pre-dilation Ratings
n=21 Participants
Participants ages 18 to 52 years with Down Syndrome rating of vision quality at near while wearing spectacles based on their pre-dilation refraction regardless of test order (worn first or second)
|
Adults: Post-dilation Ratings
n=21 Participants
Participants ages 18 to 52 years with Down Syndrome rating of vision quality at near while wearing spectacles based on their post-dilation refraction regardless of test order (worn first or second)
|
Youth: Pre-dilation Ratings
n=19 Participants
Participants ages 5 to 17 years with Down Syndrome rating of vision quality at near while wearing spectacles based on their pre-dilation refraction regardless of test order (worn first or second)
|
|---|---|---|---|---|
|
Participant Rating of Distance Vision Quality
Score 1 (very bad)
|
5.0 score on a scale
Interval 3.0 to 5.0
|
5.0 score on a scale
Interval 5.0 to 5.0
|
5.0 score on a scale
Interval 4.0 to 5.0
|
5.0 score on a scale
Interval 3.0 to 5.0
|
SECONDARY outcome
Timeframe: 1 dayPopulation: All participants aged 5 to 52 that were enrolled and subsequently randomized to a testing order.
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).
Outcome measures
| Measure |
Youth: Post-dilation Ratings
n=19 Participants
Participants ages 5 to 17 years with Down Syndrome rating of vision quality at distance while wearing spectacles based on their pre-dilation refraction regardless of test order (worn first or second)
|
Adults: Pre-dilation Ratings
n=21 Participants
Participants ages 18 to 52 years with Down Syndrome rating of vision quality at near while wearing spectacles based on their pre-dilation refraction regardless of test order (worn first or second)
|
Adults: Post-dilation Ratings
n=21 Participants
Participants ages 18 to 52 years with Down Syndrome rating of vision quality at near while wearing spectacles based on their post-dilation refraction regardless of test order (worn first or second)
|
Youth: Pre-dilation Ratings
n=19 Participants
Participants ages 5 to 17 years with Down Syndrome rating of vision quality at near while wearing spectacles based on their pre-dilation refraction regardless of test order (worn first or second)
|
|---|---|---|---|---|
|
Participant Rating of Vision Quality at Near
Score 1 (very bad)
|
5.0 score on a scale
Interval 3.0 to 5.0
|
5.0 score on a scale
Interval 4.0 to 5.0
|
5.0 score on a scale
Interval 5.0 to 5.0
|
5.0 score on a scale
Interval 3.0 to 5.0
|
SECONDARY outcome
Timeframe: 1 dayPopulation: All participants aged 5 to 52 that were enrolled and subsequently randomized to a testing order.
Participants will be asked to select which of the two prescriptions (spectacles based on pre- or post-dilation) are preferred overall.
Outcome measures
| Measure |
Youth: Post-dilation Ratings
n=8 Participants
Participants ages 5 to 17 years with Down Syndrome rating of vision quality at distance while wearing spectacles based on their pre-dilation refraction regardless of test order (worn first or second)
|
Adults: Pre-dilation Ratings
n=14 Participants
Participants ages 18 to 52 years with Down Syndrome rating of vision quality at near while wearing spectacles based on their pre-dilation refraction regardless of test order (worn first or second)
|
Adults: Post-dilation Ratings
n=7 Participants
Participants ages 18 to 52 years with Down Syndrome rating of vision quality at near while wearing spectacles based on their post-dilation refraction regardless of test order (worn first or second)
|
Youth: Pre-dilation Ratings
n=11 Participants
Participants ages 5 to 17 years with Down Syndrome rating of vision quality at near while wearing spectacles based on their pre-dilation refraction regardless of test order (worn first or second)
|
|---|---|---|---|---|
|
Participant Overall Preference for Prescriptions
Prefer post-dilation prescription
|
5 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
|
Participant Overall Preference for Prescriptions
No preference
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Participant Overall Preference for Prescriptions
Prefer pre-dilation prescription
|
3 Participants
|
8 Participants
|
3 Participants
|
8 Participants
|
Adverse Events
DS Adults
DS Youth
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place