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Clinical Trials/NCT04617223
NCT04617223
Completed
Not Applicable

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

Tanta University1 site in 1 country64 target enrollmentStarted: April 13, 2021Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
64
Locations
1
Primary Endpoint
observe improvement of ophthalmological manifestation after surgical intervention

Overview

Brief Summary

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

Detailed Description

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
1 Month to 50 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Improvement of the degree of proptosis after surgery

Time Frame: 1 month

Decrease the degree of proptosis in millimeter

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dina Tadros

MD

Tanta University

Study Sites (1)

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