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Anti-fibrotic agent in Endonasal Lacrimal Sac Surgery.

A Randomized Controlled Trial comparing efficacy of Mitomycin C(0.4mg/ml) versus no injection at the ostium in non-endoscopic endonasal dacryocystorhinostomy (DCR) with bicanalicular intubation in primary acquired nasolacrimal duct obstruction in adults

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/09/004989
Enrollment
440
Registered
2014-09-08
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Primary Acquired Nasolacrimal Duct Obstruction

Interventions

Intervention1: Mitomycin C Injection(0.4mg/ml): Non-endoscopic Endonasal Dacryocystorhinostomy with bicanalicular intubation with Mitomycin C application at the ostium site. Control Intervention1: No

Sponsors

Hyderabad Eye Research Foundation
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult patients ( >18 years) 2. Presence of regurgitation on pressure over lacrimal sac and/or regurgitation admixed with mucopurulent debris on syringing. 3. Patients who have a hard stop on probing 4. Normal eyelid function

Exclusion criteria

Exclusion criteria: 1. Patients undergoing revision DCR 2. Paediatric patients ( 3. NLDO secondary to trauma 4. Presence of any canalicular obstruction/eyelid condition responsible for epiphora 5. Anemia ( Hb 6. Presence of significant nasal pathology like deviated nasal septum, nasal polyps. 7. Patients who agree to visit the institute for 1 year or more after surgery.

Design outcomes

Primary

MeasureTime frame
Anatomical patency on syringingTimepoint: 6 months—

Secondary

MeasureTime frame
Anatomical patency Timepoint: 1 year;Functional relief from epiphoraTimepoint: 1 year;ComplicationsTimepoint: 3months, 6 months, and 1 year—

Countries

India

Contacts

Public ContactSuryasnata Rath

L V Prasad Eye Institute

drsuryasnata@gmail.com916743987999

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026