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临床试验/CTRI/2025/10/096391
CTRI/2025/10/096391进行中(未招募)不适用

Development and Effectiveness Evaluation of a Child Specific Dry Eye Screening Questionnaire (csdesq) and Daily Lifestyle Management Checklist : An Approach for Screening and Preventing Paediatric Dry Eyes

Chitkara Uinversity1 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2025年11月1日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
148
试验地点
1
主要终点
Baseline dry eye symptom score in children (6–12 years) assessed using a study-specific screening questionnaire (Tool)

研究概览

简要总结

This study aims to develop and evaluate a Child-Specific Dry Eye Screening Questionnaire (CSDESQ) and a Daily Lifestyle Management Checklist for children aged 6–12 years. The primary objective is to create and validate a screening tool (PeD-STAR) for early detection of pediatric dry eye. Children screening positive will receive a lifestyle management checklist, and changes in symptom scores will be evaluated after 3 weeks. The study focuses on early screening and prevention of pediatric dry eye through lifestyle-based, non-pharmacological interventions...........Recruitment ongoing as per approved protocol. No changes since registration.

研究设计

研究类型
Observational

入排标准

年龄范围
6.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Children aged 6 to 12 years who visit the eye hospital.
  • Informed consent obtained from parents or guardians (parents/guardians should be willing to spend sufficient time with their child).
  • Children and their parents who can understand English or Hindi and are able to respond to the questionnaire.
  • Both child and parent are willing to participate in the study.

排除标准

  • Children with significant cognitive or developmental issues or the presence of other significant eye diseases that could interfere with the diagnosis or assessment of dry eye.
  • History of other ocular surface diseases that could confound the diagnosis of dry eye.
  • Current use of contact lenses, as this can alter tear film stability.
  • Ocular surgery or trauma within the last 3 months.
  • Use of medications known to affect tear production or the ocular surface.
  • Inability to obtain parental consent.

结局指标

主要结局

Baseline dry eye symptom score in children (6–12 years) assessed using a study-specific screening questionnaire (Tool)

时间窗: Baseline (pre-intervention)

次要结局

  • Change in dry eye symptom score after following the lifestyle management checklist, assessed at 3 weeks post- Checklist intervention(Follow-up at 3 weeks post-Checklist intervention)

研究者

发起方
Chitkara Uinversity
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr Smita Singh

Chitkara School of Health Sciences, Chitkara University, Rajpura, Punjab

研究点 (1)

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