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Completed

NCT Number: NCT06226181

Amniotic Membrane for Dacryocystorhinostomy

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institiuto de Oftalmología Fundación Conde de Valenciana

Mexico City, 06800, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dacryocystorhinostomy and amniotic membrane

Procedure

Dacryocystorhinostomy surgery with amniotic membrane placement on the osteotomy site.

Conventional dacryocystorhinostomy

Procedure

Conventional dacryocystorhinostomy surgery without adding amniotic membrane

Primary outcomes

  1. Functional success rate

    Time frame: Pretreatment

    Clinical evidence of epiphora

  2. Functional success rate

    Time frame: 1 day after surgery

    Clinical evidence of epiphora

  3. Functional success rate

    Time frame: 1 week after surgery

    Clinical evidence of epiphora

  4. Functional success rate

    Time frame: 3 weeks after surgery

    Clinical evidence of epiphora

  5. Functional success rate

    Time frame: 3 months after surgery

    Clinical evidence of epiphora

  6. Functional success rate

    Time frame: 6 months after surgery

    Clinical evidence of epiphora

Secondary outcomes

  1. Osteotomy aspect

    Time frame: 1 day after surgery

    Endonasal aspect of osteotomy

  2. Osteotomy aspect

    Time frame: 6 months after surgery

    Endonasal aspect of osteotomy

  3. Nasolacrimal duct permeability

    Time frame: 1 week after surgery

    Permeability of nasolacrimal duct tested by canaliculi irrigation

  4. Nasolacrimal duct permeability

    Time frame: 3 weeks after surgery

    Permeability of nasolacrimal duct tested by canaliculi irrigation

  5. Nasolacrimal duct permeability

    Time frame: 3 months after surgery

    Permeability of nasolacrimal duct tested by canaliculi irrigation

  6. Nasolacrimal duct permeability

    Time frame: 6 months after surgery

    Permeability of nasolacrimal duct tested by canaliculi irrigation

  7. Visual acuity

    Time frame: Pre treatment

    Best corrected visual acuity

  8. Surgical Complications

    Time frame: At the date of surgery

    Adverse events or unadvertised complications at the time of the surgery

Other outcomes

  1. Visual acuity

    Time frame: 6 months after surgery

    Best corrected visual acuity

Sponsors and collaborators

Lead sponsor

Instituto de Oftalmología Fundación Conde de Valenciana

Other

Registry information

Official study title

Amniotic Membrane for External Dacryocystorhinostomy and Comparison of Success Rate With Conventional Surgery for Patients With Nasolacrimal Duct Obstruction

Acronym: AMDCRex

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 26, 2024
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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