About this trial
RCT to compare the surgical success in patients undergoing external dacryocystorhinostomy with intraoperative Mitomycin-C (0.4 mg/ml) Vs Hyaluronic acid 1% (1ml) as adjuvant, To compare the complication rates and wound healing patterns in each group, To Compare change in tear MMP-9 levels from preoperative (within 1 week before surgery) to postoperative (6 weeks after surgery) , To compare the comfort levels of patients in each group.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients within age group 18-65 years diagnosed with chronic dacryocystitis due to Primary Acquired Nasolacrimal Duct Obstruction (PANDO) qualifying for external dacryocystorhinostomy
Patients with resolved acute dacryocystitis
Disqualifiers
Acute dacryocystitis/ Lacrimal sac abscess
Secondary NLDO conditions such as infections, inflammatory, traumatic, malignant, etc.
Failed/ recurrent/ revision dacryocystorhinostomy and previous dacryocystectomy
Presence of systemic diseases affecting wound healing (eg: uncontrolled diabetes, autoimmune conditions, etc.)
Trial design
Parallel
Treatments tested in this trial
Hyaluronic Acid (HA)
DrugHyaluronic Acid (HA)
Mitomycin -C
DrugMitomycin -C
Treatment groups
Trial outcomes
Primary outcomes
1. Lacrimal irrigation test 2. diagnostic probing
1. Lacrimal irrigation test 2. diagnostic probing
Secondary outcomes
MMP-9 levels using ELISA
MMP-9 levels using ELISA
Patient Satisfaction Scale (Visual Analog Scale)
Patient Satisfaction Scale (Visual Analog Scale) minimum score: 0 maximum score: 10 best outcome : score 0 worst outcome: score 10
Locations
Sponsors and contacts
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