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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-23 | Other Grant/Funding Number | Uitzicht |
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Visual acuity at near improves in children with Down syndrome using bifocals
The accommodation is consistently reduced in 50 to 100% of children with Down syndrome and does not improve with age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single vision glasses | Active Comparator | single vision glasses |
|
| bifocals | Experimental | bifocal glasses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bifocals | Device | bifocal glasses with an addition of 2.5 Dioptres |
|
| Measure | Description | Time Frame |
|---|---|---|
| • Change from baseline in visual acuity at near measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at 16 months. | visual acuity is measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at baseline and at the end of the study 16 months later. We will calculate the difference. | baseline to 12 months later |
| Measure | Description | Time Frame |
|---|---|---|
| • Visual acuity at near measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at 16 months. | visual acuity at near measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at 16 months. | after 12 months |
| • Change from baseline in visual acuity at distance measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at 16 months. |
| Measure | Description | Time Frame |
|---|---|---|
| • Possible prognostic determinants at baseline for improvement of visual acuity at near | Applying a multivariate logistic regression model using a backward variable elimination procedure (selection criterion P < 0.05, removal criterion P < 0.10) to test a key set of independent prognostic variables (measured at baseline) for better visual acuity at near after 12 months | participants will be followed for the duration of 12 months, after the last included participant has been followed up for 18 months we will do this analysis |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| H HL Goossens, PhD | Radboudumc, Dept. Cognitive Neuroscience/126 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Isala Hospital | Zwolle | Overijssel | 8025 AB | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20626718 | Background | Nandakumar K, Leat SJ. Bifocals in children with Down syndrome (BiDS) - visual acuity, accommodation and early literacy skills. Acta Ophthalmol. 2010 Sep;88(6):e196-204. doi: 10.1111/j.1755-3768.2010.01944.x. | |
| 19470088 | Background | Al-Bagdady M, Stewart RE, Watts P, Murphy PJ, Woodhouse JM. Bifocals and Down's syndrome: correction or treatment? Ophthalmic Physiol Opt. 2009 Jul;29(4):416-21. doi: 10.1111/j.1475-1313.2009.00646.x. Epub 2009 May 11. |
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| ID | Term |
|---|---|
| D004314 | Down Syndrome |
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| single vision glasses | Device | single vision glasses |
|
Visual acuity at distance is measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at baseline and at the end of the study 16 months later. We will calculate the difference. |
| baseline to 12 months later |
| • Change from baseline in accuracy of accommodation response measured in Dioptres. | We will measure the accuracy of accommodation in Dioptres at baseline and after 16 months. We will calculate the difference. | baseline to 12 months later |
| • Change in percentage of participants with strabismus | We will calculate the percentage of participants with strabismus at baseline and at the end of the study, 16 months later. Then we can calculate the difference in percentage of participants with strabismus. | baseline to 12 months later |
| • Change in score of task readiness of the children | We will measure task readiness in scores of attention, reaction time, inhibition and working memory at baseline and at the end of the study 16 months later. Then we calculate the difference in this score. | baseline to 12 months later |
| 11133848 | Background | Cregg M, Woodhouse JM, Pakeman VH, Saunders KJ, Gunter HL, Parker M, Fraser WI, Sastry P. Accommodation and refractive error in children with Down syndrome: cross-sectional and longitudinal studies. Invest Ophthalmol Vis Sci. 2001 Jan;42(1):55-63. |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |