Examination of Lacrimal Sac and Nasal Mucosa Preparations Taken in Dacryocystorhinostomy Surgery of Patients With Nasolacrimal Duct Obstruction and Comparison of Clinical Groups With Each Other
1 other identifier
observational
78
1 country
1
Brief Summary
The goal of this observational study is to investigate etiology and pathogenesis of nasolacrimal duct obstruction and dacryocystitis in different adult clinic groups. The main question it aims to answer is: Are there differences in terms of staining scores between groups? There are 4 groups: Cohort 1: Primary Nasolacrimal Duct Obstruction without any dacryocystitis history Cohort 2: Primary Nasolacrimal Duct Obstruction with dacryocystitis history Cohort 3:Traumatic Nasolacrimal Duct Obstruction Cohort 4:Nasolacrimal Duct Obstruction with Membranes in the Nasolacrimal Sac
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2024
CompletedFirst Submitted
Initial submission to the registry
January 30, 2025
CompletedFirst Posted
Study publicly available on registry
February 5, 2025
CompletedFebruary 5, 2025
May 1, 2024
10 months
January 30, 2025
January 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Obtaining nasolacrimal sac and nasal mucosa staining scores
Obtaining nasolacrimal sac and nasal mucosa staining scores is the primary outcome measure of this study. Comparison of the staining scores of hematoxylin and eosin, Periodic Acid-Schiff and various immunohistochemical markers will be made between the study groups. It will be investigated whether there is a significant difference between the groups.
12 months
Study Arms (4)
Primary Nasolacrimal Duct Obstruction without any dacryocystitis history
Immunohistochemical staining scores of nasal mucosa nad nasolacrimal sac mucosa specimens of Primary Nasolacrimal Duct Obstruction without any dacryocystitis history who underwent external dacryocystorhinostomy surgery were compared with other groups. In this group, there were no membranes in the lacrimal sac during the surgery.
Primary Nasolacrimal Duct Obstruction with dacryocystitis history
In this group patients has had at least one dacryocystitis history. Immunohistochemical staining scores of nasal mucosa nad nasolacrimal sac mucosa specimens of Primary Nasolacrimal Duct Obstruction with dacryocystitis history who underwent external dacryocystorhinostomy surgery were compared with other groups. In this group, there were no membranes in the lacrimal sac during the surgery.
Traumatic Nasolacrimal Duct Obstruction
In this group, there were patients has traumatic nasolacrimal duct obstruction. Immunohistochemical staining scores of nasal mucosa and nasolacrimal sac mucosa specimens of Secondary Nasolacrimal Duct Obstruction who underwent external dacryocystorhinostomy surgery were compared with other groups. In this group, there were no membranes in the lacrimal sac during the surgery.
Nasolacrimal Duct Obstruction with Membranes in the Nasolacrimal Sac
In this group, dense membrane was detected in the nasolacrimal sacs during surgery. Patients with and without previous dacryocystitis who were detected to have membranes in their sacs during surgery were evaluated in this group. Immunohistochemical staining scores of nasal mucosa and nasolacrimal sac mucosa specimens of Nasolacrimal Duct Obstruction who underwent external dacryocystorhinostomy surgery were compared with other groups.
Eligibility Criteria
Patients who applied to Bursa Uludağ University, School of Medicine, Department of Ophthalmology due to nasolacrimal duct obstruction and underwent external dacryocystorhinostomy surgery and had nasal mucosa and lacrimal sac mucosa samples taken were included in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bursa Uludag University, School of Medicine
Bursa, 16059, Turkey (Türkiye)
Biospecimen
Nasal mucosa specimen and nasolacrimal sac specimen
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 4 Weeks
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof Dr, MD
Study Record Dates
First Submitted
January 30, 2025
First Posted
February 5, 2025
Study Start
May 15, 2023
Primary Completion
February 28, 2024
Study Completion
April 30, 2024
Last Updated
February 5, 2025
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share
Provide information about individual participant data may not be accepted by Institutional Review Board