Dacryocystorhinostomy, Nasolacrimal Duct Obstruction
Conditions
Keywords
Nasolacrimal Duct Obstruction, Dacryocystorhinostomy, Amniotic Membrane
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.
Interventions
PROCEDUREDacryocystorhinostomy and amniotic membrane
Dacryocystorhinostomy surgery with amniotic membrane placement on the osteotomy site.
PROCEDUREConventional dacryocystorhinostomy
Conventional dacryocystorhinostomy surgery without adding amniotic membrane
Sponsors
Instituto de Oftalmología Fundación Conde de Valenciana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and outcome assessors were masked to treatment allocation. The surgeon was not masked because of the nature of the surgical intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional success rate | Pretreatment | Clinical evidence of epiphora |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Osteotomy aspect | 1 day after surgery | Endonasal aspect of osteotomy |
| Nasolacrimal duct permeability | 1 week after surgery | Permeability of nasolacrimal duct tested by canaliculi irrigation |
| Visual acuity | Pre treatment | Best corrected visual acuity |
| Surgical Complications | At the date of surgery | Adverse events or unadvertised complications at the time of the surgery |
Countries
Mexico
Outcome results
None listed