N/A
Completed N=30
Spectacles for Patients With Down Syndrome
Vision, Low
Source: ClinicalTrials.gov NCT03367793 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcomePrimary: Adapted Visual Acuity — 0.256; 0.440; 0.356; 0.284 logMAR — p=0.341
Summary
This study tests the hypothesis that objectively derived spectacle prescriptions based on wavefront aberration measurements of the eyes of individuals with Down syndrome can provide an improvement in visual acuity over that obtained with spectacle prescriptions based on standard clinical prescribing techniques. The objectively derived prescriptions are derived using strategies to optimize retinal image quality as measured by image quality metrics, and thus these prescriptions will be referred to as metric-derived.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adapted Visual Acuity |
0.256; 0.440; 0.356; 0.284; 0.300; 0.364 | 0.341 |
| SECONDARY Initial Visual Acuity |
0.28; 0.43; 0.34; 0.28; 0.29; 0.33 | 0.410 |
| SECONDARY Spectacle Wear Time |
11.93; 13.15; 10.48; 9.81; 8.40; 11.62 | 0.351 |
| SECONDARY Spectacle Assessment Survey Question 1 |
5; 5; 5; 5; 5; 5 | 0.562 |
| SECONDARY Spectacle Assessment Survey Question 2 |
5; 5; 5; 5; 5; 5 | >0.99 |
| SECONDARY Spectacle Assessment Survey Question 3 |
5; 5; 5; 5; 5; 5 | >0.99 |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Down syndrome
Exclusion Criteria
- Nystagmus (Involuntary beating movement of the eyes)
- Visually significant media opacities (e.g. cataracts or corneal scars)
- Strabismic amblyopia (reduced vision in one eye related to a constant eye-turn)
- Anisometropic amblyopia (reduced vision in one eye related to a long-standing uncompensated difference in prescription between the two eyes)
Data sourced from ClinicalTrials.gov (NCT03367793). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.