Hyaluronic Acid vs Mitomycin-C in External Dacryocystorhinostomy
HAM-DCR
Efficacy of Hyaluronic Acid as Intraoperative Adjuvant in External Dacryocystorhinostomy Compared to Mitomycin-C: A Randomized Controlled Trial
1 other identifier
interventional
36
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Apr 2026
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2026
CompletedFirst Posted
Study publicly available on registry
March 31, 2026
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
March 31, 2026
March 1, 2026
1.6 years
March 11, 2026
March 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
1. Lacrimal irrigation test 2. diagnostic probing
1. Lacrimal irrigation test 2. diagnostic probing
6 months
Secondary Outcomes (2)
MMP-9 levels using ELISA
6 months
Patient Satisfaction Scale (Visual Analog Scale)
6 months
Study Arms (2)
Group A - Hyaluronic Acid
EXPERIMENTALHyaluronic Acid
Group B - Mitomycin-C
ACTIVE COMPARATORMitomycin-C
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.)
- Use of topical or systemic steroids/ immunosuppressants within 1 month prior to surgery
- Pregnant or lactating women
- Known allergy or hypersensitivity to MMC or HA.
- Inadequate tear volume for biomarker analysis or poor sample quality.
- Intraoperative flap complications/ excessive bleeding
- Blood stained discharge or bloody regurgitation
- Cervical or generalized lymphadenopathy
- Dry eyes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sandip K Sahu, MS
AIIMS Bhubaneswar
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 11, 2026
First Posted
March 31, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
October 30, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
March 31, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share
To maintain confidentiality of the participants.