Amniotic Membrane for Dacryocystorhinostomy (AMDCRex)

January 17, 2024 updated by: Instituto de Oftalmología Fundación Conde de Valenciana

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

This study aims to compare the success rate of external dacryocystorhinostomy with and without amniotic membranes in patients with nasolacrimal duct obstruction.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional dacryocystorhinostomy
Patients undergoing conventional dacryocystorhinostomy using external approach.
Procedure: Conventional dacryocystorhinostomy
Conventional dacryocystorhinostomy surgery without adding amniotic membrane
Experimental: Dacryocystorhinostomy using amniotic membrane
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional success rate
Time Frame: Pretreatment
Clinical evidence of epiphora
Pretreatment
Functional success rate
Time Frame: 1 day after surgery
Clinical evidence of epiphora
1 day after surgery
Functional success rate
Time Frame: 1 week after surgery
Clinical evidence of epiphora
1 week after surgery
Functional success rate
Time Frame: 3 weeks after surgery
Clinical evidence of epiphora
3 weeks after surgery
Functional success rate
Time Frame: 3 months after surgery
Clinical evidence of epiphora
3 months after surgery
Functional success rate
Time Frame: 6 months after surgery
Clinical evidence of epiphora
6 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Osteotomy aspect
Time Frame: 1 day after surgery
Endonasal aspect of osteotomy
1 day after surgery
Osteotomy aspect
Time Frame: 6 months after surgery
Endonasal aspect of osteotomy
6 months after surgery
Nasolacrimal duct permeability
Time Frame: 1 week after surgery
Permeability of nasolacrimal duct tested by canaliculi irrigation
1 week after surgery
Nasolacrimal duct permeability
Time Frame: 3 weeks after surgery
Permeability of nasolacrimal duct tested by canaliculi irrigation
3 weeks after surgery
Nasolacrimal duct permeability
Time Frame: 3 months after surgery
Permeability of nasolacrimal duct tested by canaliculi irrigation
3 months after surgery
Nasolacrimal duct permeability
Time Frame: 6 months after surgery
Permeability of nasolacrimal duct tested by canaliculi irrigation
6 months after surgery
Visual acuity
Time Frame: Pre treatment
Best corrected visual acuity
Pre treatment
Surgical Complications
Time Frame: At the date of surgery
Adverse events or unadvertised complications at the time of the surgery
At the date of surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity
Time Frame: 6 months after surgery
Best corrected visual acuity
6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Oftalmología Fundación Conde de Valenciana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

January 17, 2024

First Submitted That Met QC Criteria

January 17, 2024

First Posted (Actual)

January 26, 2024

Study Record Updates

Last Update Posted (Actual)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CI-028-2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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