NCT07754058|Completed
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Sponsor study identifier
Secondary identifiers
OTHER · Bioethics Committee at the Military Chamber of Physicians in Warsaw
interventional
60
1 country
1
Study Start
July 18, 2023
Actual (reported)Primary Completion
March 12, 2026
Actual (reported)Study Completion
March 12, 2026
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 12, 2026
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 18, 2023
Actual (reported)March 12, 2026
Actual (reported)March 12, 2026
Actual (reported)July 21, 2026
Actual (reported)August 10, 2026
Actual (reported)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
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
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
Participants assigned to this arm underwent external dacryocystorhinostomy with intraoperative application of mitomycin C.
Participants assigned to this arm underwent powered endoscopic dacryocystorhinostomy with intraoperative application of mitomycin C.
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.
Military Institute of Medicine - National Research Institute
Warsaw, Masovian Voivodeship, 04-141, Poland
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.
Sobel 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.
60 participants (actual enrollment reported by the registry).
First Submitted
July 21, 2026
First Posted
August 10, 2026
Study Start
July 18, 2023
Actual (reported)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.
Contact the study team to confirm eligibility.
Hartikainen 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.
Primary Completion
March 12, 2026
Actual (reported)Study Completion
March 12, 2026
Actual (reported)Last Updated
August 10, 2026
Record last verified: 2026-07
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.
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