An Observational, cross sectional study, to find ophthalmic disorders and their risk factors in children with developmental delay at a tertiary centre in western India.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- 1. Find out ophthalmic manifestations in children with developmental delay.
研究概览
简要总结
All the children presenting to the ophthalmology OPD will undergo the following examinations and then will be categorized according to the inclusion criteria for further evaluation.
Consent will be taken from the parents / guardian for the examination data of their child /ward to be included in the current study.
Examination includes -
* History taking (Informant will be parents / guardian)
* Visual acuity (Age-appropriate tools will be used e.g. CSM method, Snellen visual acuity chart, Kay pictures, E chart etc)
* Refraction - age-appropriate subjective as well as objective refraction
* Slit lamp biomicroscopy
* Pupillary reaction
* Dilated Fundus examination
* Assessment of Ocular alignment and Ocular Motility
* Sensory evaluation and tests of stereopsis
ENDPOINTS-
Children with developmental delay may have significant
* Refractive errors
* Nystagmus
* Strabismus
* Anisometropia
* Visual impairment
* Optic Atrophy
After the detailed recording of data, statistical analysis is to be done.
Relative risk will be calculated for the ophthalmic disorders like visual impairment, refractive errors and strabismus in relation to clinical conditions like birthweight, prematurity, birth asphyxia, cerebral palsy, epilepsy and genetic syndromes.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •Children presenting to Ophthalmic OPD with a history of developmental delay.
- •Children between 1 year and 16 years of age.
排除标准
- •Those not willing to participate in this study.
- •Children who are very uncooperative for a detailed eye examination.
结局指标
主要结局
1. Find out ophthalmic manifestations in children with developmental delay.
时间窗: As this is an cross- sectional study, the outcomes will be assessed at the baseline that is at the time of initial presentation itself.
2. To find out relative risk of various systemic conditions for corresponding ophthalmic manifestations.
时间窗: As this is an cross- sectional study, the outcomes will be assessed at the baseline that is at the time of initial presentation itself.
次要结局
- 1.To find out prevalence of optic atrophy in the examined children.(2.To find out prevalence of periventricular leucomalacia in children with MRI reports & it’s correlation with ophthalmic manifestations.)
研究者
Dr. Gayatri Pawar
Bhaktivedanta hospital and research institute