Hyaluronic Acid vs Mitomycin-C in External Dacryocystorhinostomy

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAll India Institute of Medical Sciences, Bhubaneswar

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Hyaluronic Acid (HA)

    Drug

    Hyaluronic Acid (HA)

  • Mitomycin -C

    Drug

    Mitomycin -C

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Group A - Hyaluronic AcidExperimental treatment 1 intervention
Group B: Group B - Mitomycin-CActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

1. Lacrimal irrigation test 2. diagnostic probing

1. Lacrimal irrigation test 2. diagnostic probing

Time frame
6 months

Secondary outcomes

1

MMP-9 levels using ELISA

MMP-9 levels using ELISA

Time frame
6 months
2

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

Time frame
6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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