Clinical trial NCT06810089: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dacryocystitis
Dacryocystitis; Chronic
Dacryocystorhinostomy
Epiphora
Nasolacrimal Duct Obstruction
Surfactant
Mucin
Lacrimal Sac Mucosa
Nasal Mucosa
Keywords: dacryocystitis
dacryocystorhinostomy
epiphora
nasolacrimal duct obstruction
staining
mucin
surfactant
immunohistochemical
Lead sponsor: Uludag University
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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

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.

Eligibility criteria: 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.

-

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.

-

Primary outcomes:
measure: Obtaining nasolacrimal sac and nasal mucosa staining scores
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Uludag University, School of Medicine
Study officials:
References: