Accuracy of Accommodation Clinical Trial
Official title:
The Effect of Bifocals in Children With Down Syndrome
| NCT number | NCT02241356 |
| Other study ID # | R0002308 |
| Secondary ID | 2013-23 |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | March 2014 |
| Est. completion date | June 2017 |
| Verified date | March 2020 |
| Source | Radboud University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Visual acuity at near improves in children with Down syndrome using bifocals
| Status | Completed |
| Enrollment | 120 |
| Est. completion date | June 2017 |
| Est. primary completion date | June 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 2 Years to 14 Years |
| Eligibility |
Inclusion Criteria: - Diagnosed with Down syndrome (DS) - Accommodation lag >0.5 Dioptres for children with DS <12 years and >0.75 Dioptres for children older than age 12 or Visual acuity at near is worse than at distance and >0.1 - Age range 2-14 years - Speaks Dutch as the first language - Must be verbal or able to understand instructions - Must be able to perform a task sitting on a chair and working at a table Exclusion Criteria: - Visual acuity at near < 0.1 - Not able to do vision tests at age over 5 - Has worn bifocals already - Other significant eye diseases, such as keratoconus, cataract or high myopia (>S-6.00). - Diagnoses of any neurological, sensory or behavioural disorders such as autism, microcephaly or significant hearing loss. - Prematurity, born premature after a pregnancy term less than 36 weeks - Born after severe perinatal problems |
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Isala Hospital | Zwolle | Overijssel |
| Lead Sponsor | Collaborator |
|---|---|
| Radboud University |
Netherlands,
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. — View Citation
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | • 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 | |
| Primary | • 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 | |
| Secondary | • 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 | |
| Secondary | • Change from baseline in visual acuity at distance measured in decimals and in Logarithm of the Minimum Angle of Resolution (LogMAR) at 16 months. | 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 | |
| Secondary | • 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 | |
| Secondary | • 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 | |
| Secondary | • 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 |