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

Not Applicable

Completed

• Conditions: Chronic Sinusitis
• Interventions: Procedure: Endoscopic sinus evacuation

• Registration Number: NCT04617223
• Lead Sponsor: Tanta University

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 Timeline

• Study First Submitted: 2020-10-13
• Study First Submitted QC: 2020-10-30
• Study First Posted: 2020-11-05
• Study Start: 2021-04-13
• Primary Completion: 2021-07-30
• Status Verified: 2021-09
• Study Completion: 2021-09-01
• Last Update Submitted: 2021-09-16
• Last Update Posted: 2021-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Endoscopic sinus evacuation	-

Primary Outcome Measures

Name	Time	Method
observe improvement of ophthalmological manifestation after surgical intervention	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	1 month	Decrease the degree of proptosis in millimeter

Trial Locations

Locations (1)

Tanta University Hospital; 🇪🇬 Tanta, El-Garbeia, Egypt