NCT06810089

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 5, 2025

Completed
Last Updated

February 5, 2025

Status Verified

May 1, 2024

Enrollment Period

10 months

First QC Date

January 30, 2025

Last Update Submit

January 30, 2025

Conditions

Keywords

dacryocystitisdacryocystorhinostomyepiphoranasolacrimal duct obstructionstainingmucinsurfactantimmunohistochemical

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasal mucosa specimen and nasolacrimal sac specimen

MeSH Terms

Conditions

DacryocystitisBronchiolitis Obliterans SyndromeLacrimal Apparatus DiseasesLacrimal Duct ObstructionMedullary cystic kidney disease 1

Condition Hierarchy (Ancestors)

Eye DiseasesOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

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

Locations