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临床试验/CTRI/2025/08/092602
CTRI/2025/08/092602尚未招募不适用

Ocular outcomes in patients with orbital fracture involving the orbital floor that did not undergo orbital floor repair

Department of Ophthalmology1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2025年8月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
35
试验地点
1
主要终点
1. To assess globe position, restriction of ocular movements and diplopia in patients who did not undergo orbital floor repair at the time of first presentation in ophthalmology OPD and on follow up

研究概览

简要总结

Permission to access the records in the medical records department will be taken from The Medical Superintendent. We will retrospectively review the medical records of patientswith orbital fracture who did not undergo surgical intervention

The data of vision, IOP, extra ocular movements, diplopia, globe position of the patient on their first visit to ophthalmology OPD after the accident and on their follow up will be assessed. Type of fracture will be determined with the help of CT.

The ocular outcomes of patients with orbital fracture who did not undergo surgical intervention will be analyzed

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Patients with CT proven orbital floor fractures in KH, Manipal
  • Patients who did not undergo orbital floor repair for orbital floor fracture from January 2020 to November, 2025
  • patients who did not under orbital floor repair for orbital floor fracture but underwent zygomatico- maxillary complex fracture repair from January 2020 to November, 2025.

排除标准

  • Patients for whom data on first visit or follow up data is not available.

结局指标

主要结局

1. To assess globe position, restriction of ocular movements and diplopia in patients who did not undergo orbital floor repair at the time of first presentation in ophthalmology OPD and on follow up

时间窗: 1. To assess globe position, restriction of ocular movements and diplopia in patients who did not undergo orbital floor repair at the time of first presentation in ophthalmology OPD and on 1st follow up

次要结局

  • 1.To assess vision, intraocular pressure (IOP) and extra ocular movements in patients who did not undergo orbital floor repair at the time of first presentation in ophthalmology OPD and on follow up(2.To observe variation in outcomes based on the type of orbital floor fracture determined by CT scan)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Manali Hazaraika

Kasturba Hospital, Manipal

研究点 (1)

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