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临床试验/CTRI/2025/05/086737
CTRI/2025/05/086737尚未招募不适用

An Analysis of Demographic Profile, Risk Factors and Clinical Course of Patients referred to Glaucoma Services Following Ocular Trauma at a Tertiary Eye Hospital in South India

Aravind Eye Hospital Pondicherry1 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2025年5月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
202
试验地点
1
主要终点
Clinical course and management outcomes of patients referred to Glaucoma Services following ocular trauma, assessed by intraocular pressure (IOP) control , changes at Optic Disc or Gonioscopy changes

研究概览

简要总结

This is a prospective cohort study aimed at analyzing the demographic profile, risk factors, clinical presentation, and short-term outcomes of patients referred to glaucoma services following ocular trauma at a tertiary eye hospital in South India. The study will include patients aged above 5 years with a history of ocular trauma and elevated intraocular pressure (IOP) or signs of glaucoma. A minimum of 202 eyes will be enrolled. Detailed ophthalmic evaluations will be conducted at baseline, 10 days, 1 month, and 3 months, including IOP measurements, gonioscopy, fundus examination, and visual field analysis. The study aims to assess the prevalence and mechanisms of post-traumatic ocular hypertension or glaucoma and evaluate the influence of socioeconomic factors, referral patterns, and time to presentation on treatment outcomes. Ethical approval has been obtained, and the study is classified as minor increase over minimal risk as per ICMR guidelines.

研究设计

研究类型
Observational

入排标准

年龄范围
5.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients with a documented history of ocular trauma
  • Patients referred to glaucoma services for Evaluation following Ocular Trauma or with IOP more than 21mmHg or has characteristic disc or field changes or patients with gonioscopic abnormalities post trauma.

排除标准

  • Pre-existing glaucoma or ocular hypertension.
  • Systemic conditions affecting IOP 3 Patients with Cognitive Impairment 4 Children with intellectual developmental disorders or children with special needs.

结局指标

主要结局

Clinical course and management outcomes of patients referred to Glaucoma Services following ocular trauma, assessed by intraocular pressure (IOP) control , changes at Optic Disc or Gonioscopy changes

时间窗: Follow up at 10 days, 1 month, 3 months.

次要结局

  • 1.Prevalence and distribution of different mechanisms leading to post-traumatic ocular hypertension or glaucoma.(2.Impact of socioeconomic factors, referral patterns, and time from trauma to glaucoma service presentation on short-term treatment outcomes.)

研究者

发起方
Aravind Eye Hospital Pondicherry
申办方类型
Research institution and hospital

研究点 (1)

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