Clinical Research Directory
Browse clinical research sites, groups, and studies.
External Versus Powered Endoscopic Dacryocystorhinostomy With Mitomycin C for Primary Acquired Nasolacrimal Duct Obstruction
Sponsor: Military Institute od Medicine National Research Institute
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.
Official title: External Versus Powered Endoscopic Dacryocystorhinostomy, Both With Intraoperative Mitomycin C, for Primary Acquired Nasolacrimal Duct Obstruction: A Randomized Comparative Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2023-07-18
Completion Date
2026-03-12
Last Updated
2026-08-10
Healthy Volunteers
No
Interventions
External Dacryocystorhinostomy
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
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%
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.
Locations (1)
Military Institute of Medicine - National Research Institute
Warsaw, Masovian Voivodeship, Poland