Institiuto de Oftalmología Fundación Conde de Valenciana
Mexico City, 06800, Mexico
NCT Number: NCT06226181
This study aims to compare the success rate of external dacryocystorhinostomy with and without amniotic membranes in patients with nasolacrimal duct obstruction.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Mexico City, 06800, Mexico
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dacryocystorhinostomy surgery with amniotic membrane placement on the osteotomy site.
Conventional dacryocystorhinostomy surgery without adding amniotic membrane
Time frame: Pretreatment
Clinical evidence of epiphora
Time frame: 1 day after surgery
Clinical evidence of epiphora
Time frame: 1 week after surgery
Clinical evidence of epiphora
Time frame: 3 weeks after surgery
Clinical evidence of epiphora
Time frame: 3 months after surgery
Clinical evidence of epiphora
Time frame: 6 months after surgery
Clinical evidence of epiphora
Time frame: 1 day after surgery
Endonasal aspect of osteotomy
Time frame: 6 months after surgery
Endonasal aspect of osteotomy
Time frame: 1 week after surgery
Permeability of nasolacrimal duct tested by canaliculi irrigation
Time frame: 3 weeks after surgery
Permeability of nasolacrimal duct tested by canaliculi irrigation
Time frame: 3 months after surgery
Permeability of nasolacrimal duct tested by canaliculi irrigation
Time frame: 6 months after surgery
Permeability of nasolacrimal duct tested by canaliculi irrigation
Time frame: Pre treatment
Best corrected visual acuity
Time frame: At the date of surgery
Adverse events or unadvertised complications at the time of the surgery
Time frame: 6 months after surgery
Best corrected visual acuity
Instituto de Oftalmología Fundación Conde de Valenciana
Other
Amniotic Membrane for External Dacryocystorhinostomy and Comparison of Success Rate With Conventional Surgery for Patients With Nasolacrimal Duct Obstruction
Acronym: AMDCRex
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