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
About this trial
This is an interventional treatment trial for Chronic Sinusitis
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
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
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
Learn more about this trial
Results of Endoscopic Sinus Surgery in Management of Ophthalmological Complications of Chronic Rhino Sinusitis
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