Skip to main content
OpenTrials
Completed

NCT Number: NCT04617223

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

1 month–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University Hospital

Tanta, El-Garbeia, 31515, Egypt

About this study

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:

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

Ophthalmology data collection:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Endoscopic sinus evacuation

Procedure

Evacuation of the sinus by using endoscope

Primary outcomes

  1. observe improvement of ophthalmological manifestation after surgical intervention

    Time frame: 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

  2. Improvement of the degree of proptosis after surgery

    Time frame: 1 month

    Decrease the degree of proptosis in millimeter

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 5, 2020
Registry last updated
Sep 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.