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

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

Study Overview

• Status: Completed
• Conditions: Epiphora; Dacryocystitis; Dacryocystorhinostomy; Nasolacrimal Duct Obstruction; Dacryocystitis; Chronic; Surfactant; Mucin; Lacrimal Sac Mucosa; Nasal Mucosa

Detailed Description

One of the most common complaints encountered by patients in the field of eye diseases is epiphora, or watery eyes. The most important cause of watery eyes is nasolacrimal duct obstruction (NLDO), which we frequently encounter in ophthalmology practice. NLDO is usually seen in older ages and in women, but the etiology is not fully known in the primary group. The only treatment for NLDO is surgery. The MOST successful surgical method is external dacryocystorhinostomy (ex-DCR). In this study, the pathology samples routinely taken during ex-DCR surgery from patients who apply to our clinic with NLDO will be re-examined in the Department of Pathology, and the preparations of those who meet the inclusion criteria will be taken and divided into clinical groups. Pathology samples will be examined by staining with hematoxylin & eosin, periodic acid schiff and various immunohistochemical stainings.

The study included adult patients aged 18 years and older who underwent external DCR surgery in our clinic between January 2020 and December 2022 for nasolacrimal duct obstruction and who had lacrimal sac and nasal mucosa samples obtained during surgery. Specimens are investigated prospectively .

It was aimed to examine the preparations taken during surgery of patients who underwent external dacryocystorhinostomy (DCR) surgery due to nasolacrimal duct obstruction (NLDO) by staining them with immunohistochemical staining methods for further research and to compare the clinical groups with each other.

• Study Type: Observational
• Enrollment (Actual): 78

Contacts and Locations

Study Locations

• Turkey
  • Bursa, Turkey, 16059
    • Bursa Uludag University, School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

Inclusion Criteria:The study included adult patients aged 18 years and older who underwent external DCR surgery in Ophthalmology Department between January 2020 and December 2022 for nasolacrimal duct obstruction and who had lacrimal sac and nasal mucosa samples obtained during surgery.

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Exclusion Criteria:Patients younger than 18 years of age, and patients in whom lacrimal sac and nasal mucosa were not sampled during surgery were not included in our study. In addition, patients whose outpatient and clinical examination notes were not sufficient for the study and patients who did not attend at least two postoperative follow-up examinations were not included in the study. Patients whose pathology blocks were not accessible in the Department of Pathology and patients with pathology blocks that were not suitable for histopathologic examination due to crush artifact or insufficient tissue in the preliminary examination were not included in our study.

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Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Uludag University

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: January 30, 2025
• First Submitted That Met QC Criteria: January 30, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 30, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: mucin; surfactant; dacryocystorhinostomy; staining; epiphora; immunohistochemical; nasolacrimal duct obstruction; dacryocystitis
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Duct Obstruction; Lacrimal Apparatus Diseases; Dacryocystitis
• Other Study ID Numbers: TTU-2023-1352

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Provide information about individual participant data may not be accepted by Institutional Review Board

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No