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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
Military Institute of Medicine - National Research Institute
Warsaw, Masovian Voivodeship, Poland
Anatomical Patency of the Rhinostomy
Number of participants with a patent rhinostomy ostium confirmed by both nasal endoscopic examination and lacrimal irrigation.
Time frame: 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.
Time frame: 12 months after surgery
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 to 4 months after surgery
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