This study aims to compare the success rate of external dacryocystorhinostomy with and without amniotic membranes in patients with nasolacrimal duct obstruction.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
Dacryocystorhinostomy surgery with amniotic membrane placement on the osteotomy site.
Conventional dacryocystorhinostomy surgery without adding amniotic membrane
Institiuto de Oftalmología Fundación Conde de Valenciana
Mexico City, Mexico
RECRUITINGFunctional success rate
Clinical evidence of epiphora
Time frame: Pretreatment
Functional success rate
Clinical evidence of epiphora
Time frame: 1 day after surgery
Functional success rate
Clinical evidence of epiphora
Time frame: 1 week after surgery
Functional success rate
Clinical evidence of epiphora
Time frame: 3 weeks after surgery
Functional success rate
Clinical evidence of epiphora
Time frame: 3 months after surgery
Functional success rate
Clinical evidence of epiphora
Time frame: 6 months after surgery
Osteotomy aspect
Endonasal aspect of osteotomy
Time frame: 1 day after surgery
Osteotomy aspect
Endonasal aspect of osteotomy
Time frame: 6 months after surgery
Nasolacrimal duct permeability
Permeability of nasolacrimal duct tested by canaliculi irrigation
Time frame: 1 week after surgery
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Nasolacrimal duct permeability
Permeability of nasolacrimal duct tested by canaliculi irrigation
Time frame: 3 weeks after surgery
Nasolacrimal duct permeability
Permeability of nasolacrimal duct tested by canaliculi irrigation
Time frame: 3 months after surgery
Nasolacrimal duct permeability
Permeability of nasolacrimal duct tested by canaliculi irrigation
Time frame: 6 months after surgery
Visual acuity
Best corrected visual acuity
Time frame: Pre treatment
Surgical Complications
Adverse events or unadvertised complications at the time of the surgery
Time frame: At the date of surgery