NCT06226181

Amniotic Membrane for Dacryocystorhinostomy

Amniotic Membrane for External Dacryocystorhinostomy and Comparison of Success Rate With Conventional Surgery for Patients With Nasolacrimal Duct Obstruction

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Instituto de Oftalmología Fundación Conde de Valenciana · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to compare the success rate of external dacryocystorhinostomy with and without amniotic membranes in patients with nasolacrimal duct obstruction.

Detailed description

Naso-lacrimal duct obstruction (NLDO) causes epiphora, recurrent dacryocystitis, and skin fistulas. Its incidence increases with age. Dacryocystorhinostomy (DCR) is considered the standard treatment for NLDO. Authors describe similar success rates between external or endoscopic approaches. The former uses a skin approach, through which an osteotomy is made, allowing access to the lacrimal sac and subsequently to the middle meatus of the nasal cavity. On the other hand, endoscopic surgery uses an endonasal route to create a fistula towards the lacrimal sac, with the benefit of not generating visible scars in patients. The success of both surgeries depends on creating a wide osteotomy and the preservation of the mucosa around it, reducing the risk of scarring and stenosis of the ostium formed. Some authors suggest that limiting the inflammatory process localized to the osteotomy may improve the surgical success rate. The use of mitomycin C (MMC) has been reported, with limited results due to variability in the concentration and methods of drug used. Amniotic membrane (AM) has been used in ophthalmology, such as in pterygium surgery, chemical trauma, and inflammatory diseases of the ocular surface. In these contexts, AM limits the inflammatory response, promotes re-epithelialization, and reduces fibrosis. AM epithelial cells do not express HLA-A, B, C, or DR antigens on their surface, and therefore do not present a risk of rejection by the immune system. This study aims to compare the success rate of external DCR with and without amniotic membranes in patients with NLDO.

Conditions

• Nasolacrimal Duct Obstruction
• Dacryocystorhinostomy

Interventions

Type	Name	Description
PROCEDURE	Dacryocystorhinostomy and amniotic membrane	Dacryocystorhinostomy surgery with amniotic membrane placement on the osteotomy site.
PROCEDURE	Conventional dacryocystorhinostomy	Conventional dacryocystorhinostomy surgery without adding amniotic membrane

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-02-01
• Completion: 2025-03-01
• First posted: 2024-01-26
• Last updated: 2024-01-26

Locations

1 site across 1 country: Mexico