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

Study Overview

• Status: Completed
• Conditions: Chronic Sinusitis
• Intervention / Treatment: Procedure: Endoscopic sinus evacuation

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Garbeia
    • Tanta, El-Garbeia, Egypt, 31515
      • Tanta University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 50 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Treatment	Procedure: Endoscopic sinus evacuation; Evacuation of the sinus by using endoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
observe improvement of ophthalmological manifestation after surgical intervention	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	1 month
Improvement of the degree of proptosis after surgery	Decrease the degree of proptosis in millimeter	1 month

Collaborators and Investigators

• Sponsor: Tanta University

Publications and helpful links

General Publications

• Hastan D, Fokkens WJ, Bachert C, Newson RB, Bislimovska J, Bockelbrink A, Bousquet PJ, Brozek G, Bruno A, Dahlen SE, Forsberg B, Gunnbjornsdottir M, Kasper L, Kramer U, Kowalski ML, Lange B, Lundback B, Salagean E, Todo-Bom A, Tomassen P, Toskala E, van Drunen CM, Bousquet J, Zuberbier T, Jarvis D, Burney P. Chronic rhinosinusitis in Europe--an underestimated disease. A GA(2)LEN study. Allergy. 2011 Sep;66(9):1216-23. doi: 10.1111/j.1398-9995.2011.02646.x. Epub 2011 May 24.
• Shi JB, Fu QL, Zhang H, Cheng L, Wang YJ, Zhu DD, Lv W, Liu SX, Li PZ, Ou CQ, Xu G. Epidemiology of chronic rhinosinusitis: results from a cross-sectional survey in seven Chinese cities. Allergy. 2015 May;70(5):533-9. doi: 10.1111/all.12577. Epub 2015 Mar 4.
• Chang YS, Chen PL, Hung JH, Chen HY, Lai CC, Ou CY, Chang CM, Wang CK, Cheng HC, Tseng SH. Orbital complications of paranasal sinusitis in Taiwan, 1988 through 2015: Acute ophthalmological manifestations, diagnosis, and management. PLoS One. 2017 Oct 3;12(10):e0184477. doi: 10.1371/journal.pone.0184477. eCollection 2017.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 13, 2021
• Primary Completion (ACTUAL): July 30, 2021
• Study Completion (ACTUAL): September 1, 2021

Study Registration Dates

• First Submitted: October 13, 2020
• First Submitted That Met QC Criteria: October 30, 2020
• First Posted (ACTUAL): November 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 17, 2021
• Last Update Submitted That Met QC Criteria: September 16, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis
• Other Study ID Numbers: 34062/8/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 3 month
• IPD Sharing Access Criteria: link
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No