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临床试验/CTRI/2022/01/039611
CTRI/2022/01/039611尚未招募不适用

Tear Film Studies In Vernal Keratoconjunctivitis In Pediatric Population

Department of Ophthalmology1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2022年1月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
48
试验地点
1
主要终点
Measurement of parameters related to tear film stability.

研究概览

简要总结

Vernal Keratoconjunctivitis (VKC) is a chronic, bilateral, at times asymmetrical, seasonally exacerbated allergic inflammation of the ocular surface involving the tarsal and/or bulbar conjunctiva. This is a cross sectional study to investigate the alterations in tear film stability in patients with vernal keratoconjunctivitis using tests for dry eye and meibography and to compare the results with healthy controls. The outcome parameters measured will be parameters related to tear film stability: Schirmer test ,Tear film break up time , Lissamine green stain , Meibomian gland drop-out.

研究设计

研究类型
Observational

入排标准

年龄范围
4.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • CASES: Patients with vernal keratoconjunctivitis on no treatment or only on mast cell stabilisers Children of 4 to 18 years of age presenting to the OPD with moderate to severe ocular discomfort (itching, photophobia, foreign body sensation, discharge, burning), papillae on upper tarsal conjunctiva or Horner Tranta dots on the limbus.
  • CONTROLS: Children of 4 to 18 years of age attending the OPD for refraction tests with no ocular surface problems.

排除标准

  • Patients of vernal keratoconjunctivitis on treatment with steroids or lubricant drops
  • Vernal keratoconjunctivitis with accompanying shield ulcer
  • Ocular diseases like blepharitis, active ocular infections, lid abnormalities
  • Chemical, thermal or radiation injury to eye
  • Systemic diseases (other than atopy)
  • Previous ophthalmic surgery.

结局指标

主要结局

Measurement of parameters related to tear film stability.

时间窗: at baseline

• Meibomian gland drop-out

时间窗: at baseline

• Schirmer test

时间窗: at baseline

• Tear film break up time

时间窗: at baseline

• Lissamine green stain

时间窗: at baseline

次要结局

未报告次要终点

研究者

申办方类型
Government medical college

研究点 (1)

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