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

• ClinicalTrials.gov Identifier: NCT04617223
• Recruitment Status: Completed
• First Posted: November 5, 2020
• Last Update Posted: September 17, 2021
• Sponsor: Tanta University
• Information provided by (Responsible Party): Dina Tadros, Tanta University

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

Condition or disease	Intervention/treatment	Phase
Chronic Sinusitis	Procedure: Endoscopic sinus evacuation	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 64 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Results of Endoscopic Sinus Surgery in Management of Ophthalmological Complications of Chronic Rhino Sinusitis
• Actual Study Start Date: April 13, 2021
• Actual Primary Completion Date: July 30, 2021
• Actual Study Completion Date: September 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. observe improvement of ophthalmological manifestation after surgical intervention [ Time Frame: 1 month ]

   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

2. Improvement of the degree of proptosis after surgery [ Time Frame: 1 month ]
   Decrease the degree of proptosis in millimeter

Eligibility Criteria

• Ages Eligible for Study: 1 Month to 50 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Egypt

Tanta University Hospital

Tanta, El-Garbeia, Egypt, 31515

Sponsors and Collaborators

Tanta University

More Information

Publications of Results:

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 Drunen CM, Bousquet J, Zuberbier T, Jarvis D, Burney P. Chronic rhinosinusitis in Europe--an underestimated disease. A GA²LEN 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.

• Responsible Party: Dina Tadros, MD, Tanta University
• ClinicalTrials.gov Identifier: NCT04617223
• Other Study ID Numbers: 34062/8/20
• First Posted: November 5, 2020
• Last Update Posted: September 17, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Supporting Materials: Study Protocol
• Time Frame: 3 month
• Access Criteria: link

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Sinusitis; Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases