Delayed Visual Maturation Clinical Trial
— DVMOfficial title:
Delayed Visual Maturation: Outcome and Predictive Factors
| NCT number | NCT04251338 |
| Other study ID # | S62961 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | September 3, 2019 |
| Est. completion date | February 10, 2020 |
| Verified date | January 2020 |
| Source | Universitaire Ziekenhuizen Leuven |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The objectives of the study are to describe the developmental outcome in a population of children with delayed visual maturation.
| Status | Completed |
| Enrollment | 71 |
| Est. completion date | February 10, 2020 |
| Est. primary completion date | February 10, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 3 Months to 18 Years |
| Eligibility |
Inclusion Criteria: - Infants (male or female) with suboptimal/absent visual contact at the age of =3 months, without other known general developmental delay at the time diagnosis of delayed visual contact and without anatomic ocular abnormalities at the initial ophthalmological examination. Exclusion Criteria: - Children with known underlying psychomotor developmental delay or epilepsy at first ophthalmic consultation. - Children with ophthalmic (anatomical) abnormalities that explain delayed visual maturation. |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Universitaire Ziekenhuizen Leuven | Leuven |
| Lead Sponsor | Collaborator |
|---|---|
| Universitaire Ziekenhuizen Leuven |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | delayed visual maturation. | the prevalence of developmental problems in children with delayed visual maturation. | 1998-2016 | |
| Secondary | Level of development | by questionnaire:type of education/school , problems with writing, mathematics: yes or no | 1998-2016 | |
| Secondary | Fine and gross motor skills | by questionnaire: physiotherapy needed yes or no | 1998-2016 | |
| Secondary | ophthalmological problems | by questionnaire : visual problems, wearing glasses? taped eyes? | 1998-2016 | |
| Secondary | Visual acuity | assested at the last consultation indicated in Snellen | 1998-2016 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02890251 -
Visual Maturation in Premature Newborns According to Factors Influencing Its Development
|