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

NCT04617223 | Completed DMC

• 1 other identifier: 34062/8/20
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Sinusitis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Treatment

OTHER

Procedure: Endoscopic sinus evacuation

Interventions

Endoscopic sinus evacuation PROCEDURE

Evacuation of the sinus by using endoscope

Treatment

Eligibility Criteria

• Age: 1 Month - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospital

Tanta, El-Garbeia, 31515, Egypt

Location

Related Publications (3)

• 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.

  PMID: 21605125 RESULT

• 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.

  PMID: 25631304 RESULT

• 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.

  PMID: 28972988 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: November 5, 2020
• Study Start: April 13, 2021
• Primary Completion: July 30, 2021
• Study Completion: September 1, 2021
• Last Updated: September 17, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 3 month
• Access Criteria: link

Locations

EG (1)