Clinical trial NCT06226181: Amniotic Membrane for Dacryocystorhinostomy
Official title: Amniotic Membrane for External Dacryocystorhinostomy and Comparison of Success Rate With Conventional Surgery for Patients With Nasolacrimal Duct Obstruction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Nasolacrimal Duct Obstruction
Dacryocystorhinostomy
Keywords: Nasolacrimal Duct Obstruction
Dacryocystorhinostomy
Amniotic Membrane
Lead sponsor: Instituto de Oftalmología Fundación Conde de Valenciana
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional success rate
timeFrame: Pretreatment
measure: Functional success rate
timeFrame: 1 day after surgery
measure: Functional success rate
timeFrame: 1 week after surgery
measure: Functional success rate
timeFrame: 3 weeks after surgery
measure: Functional success rate
timeFrame: 3 months after surgery
measure: Functional success rate
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Osteotomy aspect
timeFrame: 1 day after surgery
measure: Osteotomy aspect
timeFrame: 6 months after surgery
measure: Nasolacrimal duct permeability
timeFrame: 1 week after surgery
measure: Nasolacrimal duct permeability
timeFrame: 3 weeks after surgery
measure: Nasolacrimal duct permeability
timeFrame: 3 months after surgery
measure: Nasolacrimal duct permeability
timeFrame: 6 months after surgery
measure: Visual acuity
timeFrame: Pre treatment
measure: Surgical Complications
timeFrame: At the date of surgery
Other outcomes:
measure: Visual acuity
timeFrame: 6 months after surgery
Locations:
city: Mexico City
country: Mexico
facility: Institiuto de Oftalmología Fundación Conde de Valenciana
Study officials:
References:
citation: Woog JJ. The incidence of symptomatic acquired lacrimal outflow obstruction among residents of Olmsted County, Minnesota, 1976-2000 (an American Ophthalmological Society thesis). Trans Am Ophthalmol Soc. 2007;105:649-66.
citation: Tooley AA, Klingler KN, Bartley GB, Garrity JA, Woog JJ, Hodge D, Bradley EA. Dacryocystorhinostomy for Acquired Nasolacrimal Duct Stenosis in the Elderly (>/=80 Years of Age). Ophthalmology. 2017 Feb;124(2):263-267. doi: 10.1016/j.ophtha.2016.10.018. Epub 2016 Dec 13.
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citation: Gonzalvo Ibanez FJ, Fuertes Fernandez I, Fernandez Tirado FJ, Hernandez Delgado G, Rabinal Arbues F, Honrubia Lopez FM. [External dacryocystorhinostomy with mitomycin C. Clinical and anatomical evaluation with helical computed tomography]. Arch Soc Esp Oftalmol. 2000 Sep;75(9):611-7. Spanish.
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