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

Primary Purpose

Chronic Sinusitis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Endoscopic sinus evacuation
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Sinusitis

Eligibility Criteria

1 Month - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tanta University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Treatment

Arm Description

Outcomes

Primary Outcome Measures

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
Improvement of the degree of proptosis after surgery
Decrease the degree of proptosis in millimeter

Secondary Outcome Measures

Full Information

First Posted
October 13, 2020
Last Updated
September 16, 2021
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT04617223
Brief Title
Results of Endoscopic Sinus Surgery in Management of Ophthalmological Complications of Chronic Rhino Sinusitis
Official Title
Results of Endoscopic Sinus Surgery in Management of Ophthalmological Complications of Chronic Rhino Sinusitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 13, 2021 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Sinusitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Endoscopic sinus evacuation
Intervention Description
Evacuation of the sinus by using endoscope
Primary Outcome Measure Information:
Title
observe improvement of ophthalmological manifestation after surgical intervention
Description
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
Time Frame
1 month
Title
Improvement of the degree of proptosis after surgery
Description
Decrease the degree of proptosis in millimeter
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Tanta University Hospital
City
Tanta
State/Province
El-Garbeia
ZIP/Postal Code
31515
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
3 month
IPD Sharing Access Criteria
link
Citations:
PubMed Identifier
21605125
Citation
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.
Results Reference
result
PubMed Identifier
25631304
Citation
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.
Results Reference
result
PubMed Identifier
28972988
Citation
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.
Results Reference
result

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

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