跳至主要内容
临床试验/NCT04617223
NCT04617223已完成不适用

Results of Endoscopic Sinus Surgery in Management of Ophthalmological Complications of Chronic Rhino Sinusitis

Tanta University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2021年4月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
1
主要终点
observe improvement of ophthalmological manifestation after surgical intervention

研究概览

简要总结

Investigate the clinical features of orbital complications of sinusitis in the Egyptian population, and observed that certain ophthalmological manifestations and outcomes were significantly associated with disease stage

详细描述

Retrospectively review of the medical records of all patients with orbital complications of paranasal sinusitis hospitalized at the ORL-HNS department at the University of Tanta between 2010 and 2020. Sex, age, symptoms, history, ophthalmological findings, laboratory and imaging findings, treatments, and outcomes were analyzed by staging.

The data that will be retrieved from the medical records including:

  1. History taking including personal present and previous medical history.
  2. General examination
  3. Oto-rhinolaryngological clinical examination
  4. Routine preoperative laboratory investigations (e.g. complete total and differential blood count, blood sugar, coagulation profile, and renal and liver function)
  5. Diagnostic nasal Endoscopy with zero and/or a 30-degree telescope.
  6. CT paranasal sinuses with contrast, fine cuts in coronal axial, and sagittal planes.
  7. The type of intervention whether medical or surgical. 8- Culture results, treatments, hospital stay durations, and outcomes.

Ophthalmology data collection:

  1. Visual acuity (onset of decrease) (unilateral or bilateral) ant its improvement after sinus surgery
  2. Presence or absence of double vision (Diplopia)
  3. Ocular motility and if its associated with pain
  4. Proptosis (present or absent) and calculate the degree and direction
  5. Ptosis (present or absent)
  6. Pupil reactivity
  7. Fundus examination to exclude optic nerve neuropathy
  8. Association between ocular pain and headache and its improvement after surgery
  9. CT data collection (CT orbit, MRI of sinus and head)
  10. Fundus photography after surgery to see improvement of optic nerve neuropathy if present

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Month 至 50 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patient presented with preseptal/orbital inflammation secondary to acute (<1 month), subacute (1±3 months), or chronic sinusitis (>3 months) of bacterial, fungal or unidentified pathogens

排除标准

  • •Patients with chronic rhinosinusitis without orbital complication, Systemic diseases that affect the paranasal sinuses and the orbit e.g autoimmune diseases, lymphoma, leukaemia, Sinus or orbital malignancy, Data is missed from the charts

研究组 & 干预措施

Treatment

Other

干预措施: Endoscopic sinus evacuation (Procedure)

结局指标

主要结局

observe improvement of ophthalmological manifestation after surgical intervention

时间窗: 1 month

Measure the visual acuity by using Snellen chart and LogMAR chart (Logarithm of the minimum angle of resolution ) chart The Minimum number of snellen chart is 6/60 and maximum number is 6/6, The Minimum number of LogMAR chart is 1.0 and maximum number is - 0.1, The higher number means better vision

Improvement of the degree of proptosis after surgery

时间窗: 1 month

Decrease the degree of proptosis in millimeter

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dina Tadros

MD

Tanta University

研究点 (1)

Loading locations...

相似试验

Results of Endoscopic Sinus Surgery in Management of... | 临床试验