An interventional study of Dacryocystorhinostomy and amniotic membrane and Conventional dacryocystorhinostomy in Nasolacrimal Duct Obstruction and Dacryocystorhinostomy, sponsored by Instituto de Oftalmología Fundación Conde de Valenciana. Completed at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Instituto de Oftalmología Fundación Conde de Valenciana · Not applicable, Interventional, and Treatment
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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.
41 studies on the registry are indexed under Lacrimal Duct Obstruction; 8 are open to participants now.
This study's enrollment of 22 is below the median of 75 across 30 interventional studies indexed under Lacrimal Duct Obstruction.
Browse Lacrimal Duct Obstruction studies →Instituto de Oftalmología Fundación Conde de Valenciana is the lead sponsor of 45 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergoing conventional dacryocystorhinostomy using external approach.
Procedure: Conventional dacryocystorhinostomy
Patients undergoing conventional dacryocystorhinostomy using external approach and adding amniotic membrane over the osteotomy, fixed with sutures.
Procedure: Dacryocystorhinostomy and amniotic membrane
Dacryocystorhinostomy surgery with amniotic membrane placement on the osteotomy site.
Conventional dacryocystorhinostomy surgery without adding amniotic membrane
Functional 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
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
Visual acuity
Best corrected visual acuity
Time frame: 6 months after surgery
Plan to share: No
Ran from Jan 2024 to primary completion in Feb 2025, 13 months.
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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Instituto de Oftalmología Fundación Conde de Valenciana