External Versus Powered Endoscopic Dacryocystorhinostomy With Mitomycin C for Primary Acquired Nasolacrimal Duct Obstruction
2 other identifiers
interventional
60
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 12, 2026
CompletedFirst Submitted
Initial submission to the registry
July 21, 2026
CompletedFirst Posted
Study publicly available on registry
August 10, 2026
CompletedAugust 10, 2026
July 1, 2026
2.7 years
July 21, 2026
August 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Anatomical Patency of the Rhinostomy
Number of participants with a patent rhinostomy ostium confirmed by both nasal endoscopic examination and lacrimal irrigation.
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.
12 months after surgery
Secondary Outcomes (5)
Patient-Reported Perceived Surgical Effectiveness
3 to 4 months after surgery
Patient-Reported Epiphora Burden
3 to 4 months after surgery
Fluorescein Dye Disappearance Test Score
3 to 4 months after surgery
Rhinostomy Ostium Width
12 months after surgery
Discomfort Associated With Crawford Tube Intubation
3 to 4 months after surgery
Other Outcomes (2)
Willingness to Undergo the Same Procedure Again
3 to 4 months after surgery
Cosmetic Concern Related to the External Surgical Scar
3 to 4 months after surgery
Study Arms (2)
External Dacryocystorhinostomy With Mitomycin C
ACTIVE COMPARATORParticipants assigned to this arm underwent external dacryocystorhinostomy with intraoperative application of mitomycin C.
Powered Endoscopic Dacryocystorhinostomy With Mitomycin C
EXPERIMENTALParticipants assigned to this arm underwent powered endoscopic dacryocystorhinostomy with intraoperative application of mitomycin C.
Interventions
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 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 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Military Institute of Medicine - National Research Institute
Warsaw, Masovian Voivodeship, 04-141, Poland
Related Publications (3)
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.
PMID: 12511350BACKGROUNDSobel 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.
PMID: 31358391BACKGROUNDHartikainen 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.
PMID: 9627664BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2026
First Posted
August 10, 2026
Study Start
July 18, 2023
Primary Completion
March 12, 2026
Study Completion
March 12, 2026
Last Updated
August 10, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share
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.