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NCT Number: NCT07754058

External Versus Powered Endoscopic Dacryocystorhinostomy With Mitomycin C for Primary Acquired Nasolacrimal Duct Obstruction

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.

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Key information

Conditions

Primary Acquired Nasolacrimal Duct Obstruction Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Military Institute of Medicine - National Research Institute

Warsaw, Masovian Voivodeship, 04-141, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

external dacryocystorhinostomy

Procedure

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

Procedure

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%

Drug

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.

Primary outcomes

  1. Anatomical Patency of the Rhinostomy

    Time frame: 12 months after surgery

    Number of participants with a patent rhinostomy ostium confirmed by both nasal endoscopic examination and lacrimal irrigation.

  2. Epiphora Severity Assessed by the Munk Score

    Time frame: 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 outcomes

  1. Patient-Reported Perceived Surgical Effectiveness

    Time frame: 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.

  2. Patient-Reported Epiphora Burden

    Time frame: 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.

  3. Fluorescein Dye Disappearance Test Score

    Time frame: 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.

  4. Rhinostomy Ostium Width

    Time frame: 12 months after surgery

    Width of the rhinostomy ostium measured in millimeters during nasal endoscopic examination. Greater values indicated a wider postoperative rhinostomy opening.

  5. Discomfort Associated With Crawford Tube Intubation

    Time frame: 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.

Other outcomes

  1. Willingness to Undergo the Same Procedure Again

    Time frame: 3 to 4 months after surgery

    Number of participants who reported that they would be willing to undergo the same surgical procedure again if medically necessary, assessed using a yes-or-no question.

  2. Cosmetic Concern Related to the External Surgical Scar

    Time frame: 3 to 4 months after surgery

    Number of participants in the external dacryocystorhinostomy group who considered the postoperative external surgical scar to be a cosmetic problem, assessed using a yes-or-no question.

Sponsors and collaborators

Lead sponsor

Military Institute od Medicine National Research Institute

Other

Registry information

Official study title

External Versus Powered Endoscopic Dacryocystorhinostomy, Both With Intraoperative Mitomycin C, for Primary Acquired Nasolacrimal Duct Obstruction: A Randomized Comparative Study

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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