Amniotic Membrane for Dacryocystorhinostomy
- Conditions
- DacryocystorhinostomyNasolacrimal Duct Obstruction
- Interventions
- Procedure: Conventional dacryocystorhinostomyProcedure: Dacryocystorhinostomy and amniotic membrane
- Registration Number
- NCT06226181
- Lead Sponsor
- Instituto de Oftalmología Fundación Conde de Valenciana
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 32
- Patients over 18 years old
- Diagnosis of Nasolacrimal Duct Obstruction or Score ≥ 2 on the Munk Scale
- Patients able to undergo general anesthesia
- Patients able to keep follow-up
- Patients willing to participate in the study and signed informed consent
- Patients with ocular surface diseases that affect surgical outcomes, such as blepharitis, lacrimal punctum epithelization, kissing punctae, facial nerve palsy, allergic conjunctivitis, etc
- Patients with eyelid malpositions
- Patients diagnosed with systemic inflammatory diseases, such as granulomatosis with polyangiitis, sarcoidosis, etc
- Previous history of facial trauma with nasal bone fractures
- Pregnancy and lactation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional dacryocystorhinostomy Conventional dacryocystorhinostomy Patients undergoing conventional dacryocystorhinostomy using external approach. Dacryocystorhinostomy using amniotic membrane Dacryocystorhinostomy and amniotic membrane Patients undergoing conventional dacryocystorhinostomy using external approach and adding amniotic membrane over the osteotomy, fixed with sutures.
- Primary Outcome Measures
Name Time Method Functional success rate 6 months after surgery Clinical evidence of epiphora
- Secondary Outcome Measures
Name Time Method Surgical Complications At the date of surgery Adverse events or unadvertised complications at the time of the surgery
Osteotomy aspect 6 months after surgery Endonasal aspect of osteotomy
Nasolacrimal duct permeability 6 months after surgery Permeability of nasolacrimal duct tested by canaliculi irrigation
Visual acuity Pre treatment Best corrected visual acuity
Trial Locations
- Locations (1)
Institiuto de Oftalmología Fundación Conde de Valenciana
🇲🇽Mexico City, Mexico