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

Chronic Sinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04617223
• Other study ID #: 34062/8/20
• Status: Completed
• Phase: N/A
• Start date: April 13, 2021
• Est. completion date: September 1, 2021

Study information

• Verified date: September 2021
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 1, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Sinusitis
• Sinusitis

Intervention

Procedure:
• Endoscopic sinus evacuation
Evacuation of the sinus by using endoscope

Locations

Country	Name	City	State
Egypt	Tanta University Hospital	Tanta	El-Garbeia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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 — View Citation

Hastan D, Fokkens WJ, Bachert C, Newson RB, Bislimovska J, Bockelbrink A, Bousquet PJ, Brozek G, Bruno A, Dahlén SE, Forsberg B, Gunnbjörnsdóttir M, Kasper L, Krämer U, Kowalski ML, Lange B, Lundbäck B, Salagean E, Todo-Bom A, Tomassen P, Toskala E, van D — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Improvement of the degree of proptosis after surgery	Decrease the degree of proptosis in millimeter	1 month