DacryocystitisNCT06810089
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
An observational study of Dacryocystitis and Dacryocystitis; Chronic, run by Uludag University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dacryocystitis, Dacryocystitis; Chronic, Dacryocystorhinostomy
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2023to 30 Apr 2024
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
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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Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Uludag University, School of Medicine
Bursa, 16059
About this study
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
Read the 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.
- Conditions
- Dacryocystitis, Dacryocystitis; Chronic, Dacryocystorhinostomy, Epiphora, Nasolacrimal Duct Obstruction, Surfactant
- Keywords
- dacryocystitis, dacryocystorhinostomy, epiphora, nasolacrimal duct obstruction, staining, mucin, surfactant, immunohistochemical
- Medical subject headings
- Dacryocystitis, Bronchiolitis Obliterans Syndrome, Lacrimal Apparatus Diseases, Lacrimal Duct Obstruction, Medullary cystic kidney disease 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start15 May 2023
- Primary completion28 Feb 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DacryocystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 78 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sertac Argun Kivanc, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810089
- Sponsor's protocol ID
- TTU-2023-1352
- Status last verified
- May 2024
- First submitted
- 30 Jan 2025
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Provide information about individual participant data may not be accepted by Institutional Review Board
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06810089
- Acronym / sponsor ID
- TTU-2023-1352
- Conditions
- Dacryocystitis, Dacryocystitis; Chronic, Dacryocystorhinostomy, Epiphora, Nasolacrimal Duct Obstruction, Surfactant
- Keywords
- dacryocystitis, dacryocystorhinostomy, epiphora, nasolacrimal duct obstruction, staining, mucin, surfactant, immunohistochemical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 4 Weeks
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Obtaining nasolacrimal sac and nasal mucosa staining scores
Time frame: 12 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Individual participant dataSharing planned: No. Provide information about individual participant data may not be accepted by Institutional Review Board
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dacryocystitis and Dacryocystitis; Chronic, run by Uludag University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obtaining nasolacrimal sac and nasal mucosa staining scores (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.