An observational study in Dacryocystitis, Dacryocystitis; Chronic and Dacryocystorhinostomy, sponsored by Uludag University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-05.
Sponsored by Uludag University · Observational
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
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.
34 studies on the registry are indexed under Lacrimal Duct Obstruction; 6 are open to participants now.
This study's enrollment of 78 is below the median of 97 across 10 observational studies indexed under Lacrimal Duct Obstruction.
Browse Lacrimal Duct Obstruction studies →Uludag University is the lead sponsor of 141 studies on the registry; 39 are open to participants now.
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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.
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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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.
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.
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.
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.
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.
Time frame: 12 months
Plan to share: No — Provide information about individual participant data may not be accepted by Institutional Review Board
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