Primary Acquired Nasolacrimal Duct ObstructionNCT07754058
External Versus Powered Endoscopic Dacryocystorhinostomy With Mitomycin C for Primary Acquired Nasolacrimal Duct Obstruction
A study testing External Dacryocystorhinostomy, Powered Endoscopic Dacryocystorhinostomy and Mitomycin C 0.02% in people with Primary Acquired Nasolacrimal Duct Obstruction, run by Military Institute od Medicine National Research Institute at 1 site in Poland.
Trial summary
Primary acquired nasolacrimal duct obstruction causes persistent tearing because tears cannot drain normally from the eye into the nose. The purpose of this randomized study was to compare two operations used to restore tear drainage: external dacryocystorhinostomy, performed through a small skin incision near the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Acquired Nasolacrimal Duct Obstruction
- What is being tested?
- External Dacryocystorhinostomy, Powered Endoscopic Dacryocystorhinostomy and Mitomycin C 0.02%
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 18 Jul 2023to 12 Mar 2026
- Phase
- Interventional
- 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
Who may be able to join
- Age 18 years or older.
- Unilateral or bilateral pathological epiphora not expected to improve with conservative treatment.
- Confirmed primary acquired obstruction at the level of the lacrimal sac or nasolacrimal duct, with an indication for dacryocystorhinostomy.
- General health status permitting surgery under general anesthesia and participation in the 12-month follow-up.
- Ability to understand the study requirements and comply with the scheduled study procedures and follow-up visits.
- Written informed consent to participate in the study and undergo surgery.
Who cannot join
- History of previous lacrimal drainage surgery, including external, endoscopic, or laser-assisted dacryocystorhinostomy.
- Acute inflammation or infection of the lacrimal drainage system, nasal cavity, or paranasal sinuses.
- Suspected neoplastic lesion of the lacrimal drainage system, nasal cavity, or paranasal sinuses.
- Clinically significant abnormalities of the eyelids or ocular adnexa that could contribute to epiphora.
- History of eyelid surgery.
- Documented hypersensitivity to mitomycin C or any medication used during the preoperative, intraoperative, or postoperative procedures.
Show all 12Show fewer
- Cognitive impairment, psychiatric disorder, or emotional instability preventing valid informed consent or adherence to the study procedures.
- Inability or unwillingness to comply with the scheduled examinations and follow-up visits.
- General medical condition precluding surgery under general anesthesia.
- Serious life-limiting disease or another medical condition preventing completion of the 12-month follow-up.
- Pregnancy or breastfeeding.
- Women of childbearing potential not using an accepted method of contraception.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Military Institute of Medicine - National Research Institute
Warsaw, Masovian Voivodeship, 04-141
About this study
Official title: External Versus Powered Endoscopic Dacryocystorhinostomy, Both With Intraoperative Mitomycin C, for Primary Acquired Nasolacrimal Duct Obstruction: A Randomized Comparative Study
Primary acquired nasolacrimal duct obstruction causes persistent tearing because tears cannot drain normally from the eye into the nose. The purpose of this randomized study was to compare two operations used to restore tear drainage: external dacryocystorhinostomy, performed through a small skin incision near the inner corner of the eye, and powered endoscopic dacryocystorhinostomy, performed through the nose using an endoscope and powered instruments, with mitomycin C applied during surgery to reduce scar formation.
Participants were assigned to the two surgical groups using a pre-generated randomization list. Recruitment was completed after 60 participants had been enrolled, resulting in 30 participants in each group. Participants were followed for 12 months after surgery.
The main outcomes were whether the newly created tear drainage opening remained open and whether tearing symptoms improved. Additional assessments included postoperative symptom severity, patient satisfaction, surgical complications, cosmetic concerns related to the external scar, and willingness to undergo the same procedure again.
Read the detailed description
This was a prospective, randomized, single-center clinical study involving patients with primary acquired nasolacrimal duct obstruction. The study compared external dacryocystorhinostomy with powered endoscopic dacryocystorhinostomy performed with intraoperative application of mitomycin C.
Participants were assigned to the two surgical groups using a pre-generated randomization list. Recruitment was completed after 60 participants had been enrolled, resulting in 30 participants in the external dacryocystorhinostomy group and 30 participants in the powered endoscopic dacryocystorhinostomy group.
Participants were followed for 12 months after surgery. Anatomical success was defined as a patent rhinostomy opening confirmed by nasal endoscopic examination and lacrimal irrigation. Functional success was defined as a postoperative Munk score of 1 or lower. Overall surgical success required both anatomical and functional success.
Additional assessments included postoperative Munk score, complete resolution of tearing defined as a Munk score of 0, patient satisfaction, willingness to undergo the same procedure again, postoperative complications, and cosmetic concerns related to the external surgical scar.
- Being tested
- External Dacryocystorhinostomy, Powered Endoscopic Dacryocystorhinostomy, Mitomycin C 0.02%
- Keywords
- PANDO, Epiphora, Dacryocystorhinostomy, External Dacryocystorhinostomy, Powered Endoscopic Dacryocystorhinostomy, Mitomycin C, Lacrimal Drainage Surgery
- Medical subject headings
- Lacrimal Apparatus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External DacryocystorhinostomyProcedure or surgery
External dacryocystorhinostomy was performed through a skin incision near the medial canthus. A bony ostium was created between the lacrimal sac and the nasal cavity, and the lacrimal and nasal mucosal flaps were opened and anastomosed to establish a new tear drainage pathway.
Powered Endoscopic DacryocystorhinostomyProcedure or surgery
Powered endoscopic dacryocystorhinostomy was performed through the nasal cavity using an endoscope, a microdebrider, and a powered drill. The lacrimal sac was widely exposed and opened to create a new tear drainage pathway into the nasal cavity.
Mitomycin C 0.02%Drug
Mitomycin C at a concentration of 0.2 mg/mL was administered to the lateral nasal mucosa around the rhinostomy site. Sponges soaked with mitomycin C were applied to the edges of the newly created rhinostomy for 3 minutes during both external and powered endoscopic dacryocystorhinostomy.
| Study group | Role | What they receive |
|---|---|---|
| External Dacryocystorhinostomy With Mitomycin C | Active comparator | Participants assigned to this arm underwent external dacryocystorhinostomy with intraoperative application of mitomycin C. Receives: Procedure: External Dacryocystorhinostomy; Drug: Mitomycin C 0.02% |
| Powered Endoscopic Dacryocystorhinostomy With Mitomycin C | Experimental | Participants assigned to this arm underwent powered endoscopic dacryocystorhinostomy with intraoperative application of mitomycin C. Receives: Procedure: Powered Endoscopic Dacryocystorhinostomy; Drug: Mitomycin C 0.02% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomical Patency of the Rhinostomy
Number of participants with a patent rhinostomy ostium confirmed by both nasal endoscopic examination and lacrimal irrigation.
Measured: 12 months after surgery
Epiphora Severity Assessed by the Munk Score
Epiphora severity was assessed using the Munk score ranging from 0 to 5. A score of 0 indicated no tearing, and a score of 5 indicated constant tearing requiring continuous wiping. Lower scores indicated less severe epiphora.
Measured: 12 months after surgery
Secondary outcomes (5)
Patient-Reported Perceived Surgical Effectiveness
Participant-reported perceived effectiveness of the surgical procedure assessed on a 5-point scale, ranging from 1, indicating very low effectiveness, to 5, indicating very high effectiveness. Higher scores indicated greater perceived effectiveness.
Measured: 3 to 4 months after surgery
Patient-Reported Epiphora Burden
Participant-reported burden of epiphora assessed using a 5-point verbal rating scale ranging from 1 to 5. A score of 1 indicated no or minimal burden, and a score of 5 indicated maximum burden. Lower scores indicated less troublesome epiphora.
Measured: 3 to 4 months after surgery
Fluorescein Dye Disappearance Test Score
Tear drainage was assessed using the fluorescein dye disappearance test on a scale from 0 to 4. Scores of 0 or 1 indicated normal or nearly normal tear drainage, whereas scores from 2 to 4 indicated increasing fluorescein retention and impaired tear drainage. Lower scores indicated better tear drainage.
Measured: 3 to 4 months after surgery
Rhinostomy Ostium Width
Width of the rhinostomy ostium measured in millimeters during nasal endoscopic examination. Greater values indicated a wider postoperative rhinostomy opening.
Measured: 12 months after surgery
Discomfort Associated With Crawford Tube Intubation
Number of participants who reported discomfort associated with the implanted Crawford silicone tube, assessed using a yes-or-no question.
Measured: 3 to 4 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start18 Jul 2023
- Primary completion12 Mar 2026
- Study completion12 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Primary Acquired Nasolacrimal Duct ObstructionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned using a pre-generated randomization list to undergo either external dacryocystorhinostomy or powered endoscopic dacryocystorhinostomy.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Military Institute od Medicine National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754058
- Sponsor's protocol ID
- WIM-ExDCR-EnDCR-2023
- Other IDs
- 3/23
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study consent and ethics documentation did not establish a formal mechanism for sharing de-identified individual-level data with external researchers.
Publications
Dolman PJ. Comparison of external dacryocystorhinostomy with nonlaser endonasal dacryocystorhinostomy. Ophthalmology. 2003 Jan;110(1):78-84. doi: 10.1016/s0161-6420(02)01452-5.
PubMed 12511350Sobel RK, Aakalu VK, Wladis EJ, Bilyk JR, Yen MT, Mawn LA. A Comparison of Endonasal Dacryocystorhinostomy and External Dacryocystorhinostomy: A Report by the American Academy of Ophthalmology. Ophthalmology. 2019 Nov;126(11):1580-1585. doi: 10.1016/j.ophtha.2019.06.009. Epub 2019 Jul 26.
PubMed 31358391Hartikainen J, Grenman R, Puukka P, Seppa H. Prospective randomized comparison of external dacryocystorhinostomy and endonasal laser dacryocystorhinostomy. Ophthalmology. 1998 Jun;105(6):1106-13. doi: 10.1016/S0161-6420(98)96015-8.
PubMed 9627664
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Versus Powered Endoscopic Dacryocystorhinostomy, Both With Intraoperative Mitomycin C, for Primary Acquired Nasolacrimal Duct Obstruction: A Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT07754058
- Acronym / sponsor ID
- WIM-ExDCR-EnDCR-2023
- Keywords
- PANDO, Epiphora, Dacryocystorhinostomy, External Dacryocystorhinostomy, Powered Endoscopic Dacryocystorhinostomy, Mitomycin C, Lacrimal Drainage Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Military Institute od Medicine National Research InstituteUniversity, hospital or other
- Study start
- 18 Jul 2023 (actual)
- Primary completion
- 12 Mar 2026 (actual)
- Study completion
- 12 Mar 2026 (actual)
- First posted
- 10 Aug 2026 (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.
Primary acquired nasolacrimal duct obstruction causes persistent tearing because tears cannot drain normally from the eye into the nose. The purpose of this randomized study was to compare two operations used to restore tear drainage: external dacryocystorhinostomy, performed through a small skin incision near the inner corner of the eye, and powered endoscopic dacryocystorhinostomy, performed through the nose using an endoscope and powered instruments, with mitomycin C applied during surgery to reduce scar formation.
Participants were assigned to the two surgical groups using a pre-generated randomization list. Recruitment was completed after 60 participants had been enrolled, resulting in 30 participants in each group. Participants were followed for 12 months after surgery.
The main outcomes were whether the newly created tear drainage opening remained open and whether tearing symptoms improved. Additional assessments included postoperative symptom severity, patient satisfaction, surgical complications, cosmetic concerns related to the external scar, and willingness to undergo the same procedure again.
Detailed description
This was a prospective, randomized, single-center clinical study involving patients with primary acquired nasolacrimal duct obstruction. The study compared external dacryocystorhinostomy with powered endoscopic dacryocystorhinostomy performed with intraoperative application of mitomycin C.
Participants were assigned to the two surgical groups using a pre-generated randomization list. Recruitment was completed after 60 participants had been enrolled, resulting in 30 participants in the external dacryocystorhinostomy group and 30 participants in the powered endoscopic dacryocystorhinostomy group.
Participants were followed for 12 months after surgery. Anatomical success was defined as a patent rhinostomy opening confirmed by nasal endoscopic examination and lacrimal irrigation. Functional success was defined as a postoperative Munk score of 1 or lower. Overall surgical success required both anatomical and functional success.
Additional assessments included postoperative Munk score, complete resolution of tearing defined as a Munk score of 0, patient satisfaction, willingness to undergo the same procedure again, postoperative complications, and cosmetic concerns related to the external surgical scar.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned using a pre-generated randomization list to undergo either external dacryocystorhinostomy or powered endoscopic dacryocystorhinostomy.
| Arm | Type | Receives |
|---|---|---|
| External Dacryocystorhinostomy With Mitomycin C | Active comparator | Procedure: External Dacryocystorhinostomy, Drug: Mitomycin C 0.02%Participants assigned to this arm underwent external dacryocystorhinostomy with intraoperative application of mitomycin C. |
| Powered Endoscopic Dacryocystorhinostomy With Mitomycin C | Experimental | Procedure: Powered Endoscopic Dacryocystorhinostomy, Drug: Mitomycin C 0.02%Participants assigned to this arm underwent powered endoscopic dacryocystorhinostomy with intraoperative application of mitomycin C. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older.
- Unilateral or bilateral pathological epiphora not expected to improve with conservative treatment.
- Confirmed primary acquired obstruction at the level of the lacrimal sac or nasolacrimal duct, with an indication for dacryocystorhinostomy.
- General health status permitting surgery under general anesthesia and participation in the 12-month follow-up.
- Ability to understand the study requirements and comply with the scheduled study procedures and follow-up visits.
Key exclusion criteria (12 listed)
- History of previous lacrimal drainage surgery, including external, endoscopic, or laser-assisted dacryocystorhinostomy.
- Acute inflammation or infection of the lacrimal drainage system, nasal cavity, or paranasal sinuses.
- Suspected neoplastic lesion of the lacrimal drainage system, nasal cavity, or paranasal sinuses.
- Clinically significant abnormalities of the eyelids or ocular adnexa that could contribute to epiphora.
- History of eyelid surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External DacryocystorhinostomyExternal dacryocystorhinostomy was performed through a skin incision near the medial canthus. A bony ostium was created between the lacrimal sac and the nasal cavity, and the lacrimal and nasal mucosal flaps were opened and anastomosed to establish a new tear drainage pathway. | Procedure or surgery | External Dacryocystorhinostomy With Mitomycin C |
| Powered Endoscopic DacryocystorhinostomyPowered endoscopic dacryocystorhinostomy was performed through the nasal cavity using an endoscope, a microdebrider, and a powered drill. The lacrimal sac was widely exposed and opened to create a new tear drainage pathway into the nasal cavity. | Procedure or surgery | Powered Endoscopic Dacryocystorhinostomy With Mitomycin C |
| Mitomycin C 0.02%Mitomycin C at a concentration of 0.2 mg/mL was administered to the lateral nasal mucosa around the rhinostomy site. Sponges soaked with mitomycin C were applied to the edges of the newly created rhinostomy for 3 minutes during both external and powered endoscopic dacryocystorhinostomy. | Drug | External Dacryocystorhinostomy With Mitomycin C, Powered Endoscopic Dacryocystorhinostomy With Mitomycin C |
Primary outcome
Anatomical Patency of the Rhinostomy
Time frame: 12 months after surgery
Number of participants with a patent rhinostomy ostium confirmed by both nasal endoscopic examination and lacrimal irrigation.
Epiphora Severity Assessed by the Munk Score
Time frame: 12 months after surgery
Epiphora severity was assessed using the Munk score ranging from 0 to 5. A score of 0 indicated no tearing, and a score of 5 indicated constant tearing requiring continuous wiping. Lower scores indicated less severe epiphora.
5 secondary outcomes
Patient-Reported Perceived Surgical Effectiveness
Time frame: 3 to 4 months after surgery
Patient-Reported Epiphora Burden
Time frame: 3 to 4 months after surgery
Fluorescein Dye Disappearance Test Score
Time frame: 3 to 4 months after surgery
Rhinostomy Ostium Width
Time frame: 12 months after surgery
Discomfort Associated With Crawford Tube Intubation
Time frame: 3 to 4 months after surgery
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 10 Aug 2026.
- Background: PubMed 12511350Dolman PJ. Comparison of external dacryocystorhinostomy with nonlaser endonasal dacryocystorhinostomy. Ophthalmology. 2003 Jan;110(1):78-84. doi: 10.1016/s0161-6420(02)01452-5.
- Background: PubMed 31358391Sobel RK, Aakalu VK, Wladis EJ, Bilyk JR, Yen MT, Mawn LA. A Comparison of Endonasal Dacryocystorhinostomy and External Dacryocystorhinostomy: A Report by the American Academy of Ophthalmology. Ophthalmology. 2019 Nov;126(11):1580-1585. doi: 10.1016/j.ophtha.2019.06.009. Epub 2019 Jul 26.
- Background: PubMed 9627664Hartikainen J, Grenman R, Puukka P, Seppa H. Prospective randomized comparison of external dacryocystorhinostomy and endonasal laser dacryocystorhinostomy. Ophthalmology. 1998 Jun;105(6):1106-13. doi: 10.1016/S0161-6420(98)96015-8.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study consent and ethics documentation did not establish a formal mechanism for sharing de-identified individual-level data with external researchers.
Related trials for Primary Acquired Nasolacrimal Duct Obstruction
Not yet recruiting
Outcomes of Stentless Dacryocystorhinostomy in Primary Acquired Nasolacrimal Duct Obstruction.
Nasolacrimal Duct Obstruction, Epiphora
Recruiting
Comparative Outcomes of Four Versus Two Balloon Inflation Points in Dacryoplasty for Primary Acquired Nasolacrimal Duct Obstruction
Primary Acquired Nasolacrimal Duct Obstruction
Recruiting
Efficacy Evaluation of 5-Fluorouracil as an Adjuvant to Endoscopic Dacryocystorhinostomy in Managing Primary Acquired Nasolacrimal Duct Obstruction With Small Lacrimal Sac: A Randomized Controlled Study
Primary Acquired Nasolacrimal Duct Obstruction
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?
A study testing External Dacryocystorhinostomy, Powered Endoscopic Dacryocystorhinostomy and Mitomycin C 0.02% in people with Primary Acquired Nasolacrimal Duct Obstruction, run by Military Institute od Medicine National Research Institute at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. 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 10 Aug 2026. 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 Poland. 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?
Anatomical Patency of the Rhinostomy (time frame: 12 months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07754058, which also lists 3 linked publications.
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 10 Aug 2026.