Primary Acquired Nasolacrimal Duct Obstruction
Conditions
Keywords
PANDO, Epiphora, Dacryocystorhinostomy, External Dacryocystorhinostomy, Powered Endoscopic Dacryocystorhinostomy, Mitomycin C, Lacrimal Drainage Surgery
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.
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.
Interventions
PROCEDUREExternal 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.
PROCEDUREPowered 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 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.
Sponsors
Military Institute od Medicine National Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants were randomly assigned using a pre-generated randomization list to undergo either external dacryocystorhinostomy or powered endoscopic dacryocystorhinostomy.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anatomical Patency of the Rhinostomy | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Perceived Surgical Effectiveness | 3 to 4 months after surgery | 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. |
| Patient-Reported Epiphora Burden | 3 to 4 months after surgery | 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. |
| Fluorescein Dye Disappearance Test Score | 3 to 4 months after surgery | 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. |
| Rhinostomy Ostium Width | 12 months after surgery | Width of the rhinostomy ostium measured in millimeters during nasal endoscopic examination. Greater values indicated a wider postoperative rhinostomy opening. |
| Discomfort Associated With Crawford Tube Intubation | 3 to 4 months after surgery | Number of participants who reported discomfort associated with the implanted Crawford silicone tube, assessed using a yes-or-no question. |
Countries
Poland
Outcome results
None listed