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AzTrials

Nasolacrimal Duct ObstructionAMDCRexNCT06226181

Amniotic Membrane for Dacryocystorhinostomy

A study testing Dacryocystorhinostomy and amniotic membrane and Conventional dacryocystorhinostomy in people with Nasolacrimal Duct Obstruction and Dacryocystorhinostomy, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
Dacryocystorhinostomy and amniotic membrane and Conventional dacryocystorhinostomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteMexico
Study dates
1 Jan 2024to 1 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Institiuto de Oftalmología Fundación Conde de Valenciana

    Mexico City, Mexico City, 06800

Other trials in Mexico

About this study

Official title: 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.

Read the 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.

Being tested
Dacryocystorhinostomy and amniotic membrane, Conventional dacryocystorhinostomy
Keywords
Nasolacrimal Duct Obstruction, Dacryocystorhinostomy, Amniotic Membrane
Medical subject headings
Lacrimal Duct Obstruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dacryocystorhinostomy and amniotic membraneProcedure or surgery

    Dacryocystorhinostomy surgery with amniotic membrane placement on the osteotomy site.

  • Conventional dacryocystorhinostomyProcedure or surgery

    Conventional dacryocystorhinostomy surgery without adding amniotic membrane

Study groups in NCT06226181
Study groupRoleWhat they receive
Conventional dacryocystorhinostomyActive comparatorPatients undergoing conventional dacryocystorhinostomy using external approach.
Receives: Procedure: Conventional dacryocystorhinostomy
Dacryocystorhinostomy using amniotic membraneExperimentalPatients undergoing conventional dacryocystorhinostomy using external approach and adding amniotic membrane over the osteotomy, fixed with sutures.
Receives: Procedure: Dacryocystorhinostomy and amniotic membrane

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional success rate

    Clinical evidence of epiphora

    Measured: Pretreatment

  2. Functional success rate

    Clinical evidence of epiphora

    Measured: 1 day after surgery

  3. Functional success rate

    Clinical evidence of epiphora

    Measured: 1 week after surgery

  4. Functional success rate

    Clinical evidence of epiphora

    Measured: 3 weeks after surgery

  5. Functional success rate

    Clinical evidence of epiphora

    Measured: 3 months after surgery

  6. Functional success rate

    Clinical evidence of epiphora

    Measured: 6 months after surgery

Secondary outcomes (8)

  1. Osteotomy aspect

    Endonasal aspect of osteotomy

    Measured: 1 day after surgery

  2. Osteotomy aspect

    Endonasal aspect of osteotomy

    Measured: 6 months after surgery

  3. Nasolacrimal duct permeability

    Permeability of nasolacrimal duct tested by canaliculi irrigation

    Measured: 1 week after surgery

  4. Nasolacrimal duct permeability

    Permeability of nasolacrimal duct tested by canaliculi irrigation

    Measured: 3 weeks after surgery

  5. Nasolacrimal duct permeability

    Permeability of nasolacrimal duct tested by canaliculi irrigation

    Measured: 3 months after surgery

  6. Nasolacrimal duct permeability

    Permeability of nasolacrimal duct tested by canaliculi irrigation

    Measured: 6 months after surgery

  7. Visual acuity

    Best corrected visual acuity

    Measured: Pre treatment

  8. Surgical Complications

    Adverse events or unadvertised complications at the time of the surgery

    Measured: At the date of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2024
  2. Study start1 Jan 2024
  3. Primary completion1 Feb 2025
  4. Study completion1 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06226181
Sponsor's protocol ID
CI-028-2017
Acronym
AMDCRex
Status last verified
Sep 2026
First submitted
17 Jan 2024
Last updated
4 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 18427633

  • 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.

    PubMed 27986382

  • Miranda Anta S, Blanco Mateos G, Valverde Collar C. [Dacryocystorhinostomy in adolescents and young adults]. Arch Soc Esp Oftalmol. 2011 Aug;86(8):243-6. doi: 10.1016/j.oftal.2010.12.014. Epub 2011 Jun 15. Spanish.

    PubMed 21821190

  • Huang J, Malek J, Chin D, Snidvongs K, Wilcsek G, Tumuluri K, Sacks R, Harvey RJ. Systematic review and meta-analysis on outcomes for endoscopic versus external dacryocystorhinostomy. Orbit. 2014 Apr;33(2):81-90. doi: 10.3109/01676830.2013.842253. Epub 2013 Dec 19.

    PubMed 24354575

  • Barmettler A, Ehrlich JR, Lelli G Jr. Current preferences and reported success rates in dacryocystorhinostomy amongst ASOPRS members. Orbit. 2013 Feb;32(1):20-6. doi: 10.3109/01676830.2012.747211.

    PubMed 23387450

  • Ali MJ, Psaltis AJ, Wormald PJ. Dacryocystorhinostomy ostium: parameters to evaluate and DCR ostium scoring. Clin Ophthalmol. 2014 Dec 9;8:2491-9. doi: 10.2147/OPTH.S73998. eCollection 2014.

    PubMed 25525327

  • 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.

    PubMed 11151233

  • Liao SL, Kao SC, Tseng JH, Chen MS, Hou PK. Results of intraoperative mitomycin C application in dacryocystorhinostomy. Br J Ophthalmol. 2000 Aug;84(8):903-6. doi: 10.1136/bjo.84.8.903.

    PubMed 10906101

  • Nair AG, Ali MJ. Mitomycin-C in dacryocystorhinostomy: From experimentation to implementation and the road ahead: A review. Indian J Ophthalmol. 2015 Apr;63(4):335-9. doi: 10.4103/0301-4738.158082.

    PubMed 26044474

  • Arya SK, Bhala S, Malik A, Sood S. Role of amniotic membrane transplantation in ocular surface disorders. Nepal J Ophthalmol. 2010 Jul-Dec;2(2):145-53. doi: 10.3126/nepjoph.v2i2.3722.

    PubMed 21505532

  • Chavez-Garcia C, Jimenez-Corona A, Graue-Hernandez EO, Zaga-Clavellina V, Garcia-Mejia M, Jimenez-Martinez MC, Garfias Y. Ophthalmic indications of amniotic membrane transplantation in Mexico: an eight years Amniotic Membrane Bank experience. Cell Tissue Bank. 2016 Jun;17(2):261-8. doi: 10.1007/s10561-015-9540-7. Epub 2015 Dec 16.

    PubMed 26675894

  • Liu J, Sheha H, Fu Y, Liang L, Tseng SC. Update on amniotic membrane transplantation. Expert Rev Ophthalmol. 2010 Oct;5(5):645-661. doi: 10.1586/eop.10.63.

    PubMed 21436959

  • Nava-Castaneda A, Tovila-Canales JL, Monroy-Serrano MH, Tapia-Guerra V, Tovilla-Y-Pomar JL, Ordonez-Blanco A, Garnica-Hayashi L, Garfias-Becerra Y. [Comparative study of amniotic membrane transplantation, with and without simultaneous application of mitomycin C in conjunctival fornix reconstruction]. Arch Soc Esp Oftalmol. 2005 Jun;80(6):345-52. doi: 10.4321/s0365-66912005000600008. Spanish.

    PubMed 15986275

Questions about this trial

What is this clinical trial studying?

A study testing Dacryocystorhinostomy and amniotic membrane and Conventional dacryocystorhinostomy in people with Nasolacrimal Duct Obstruction and Dacryocystorhinostomy, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional success rate (time frame: Pretreatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06226181, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.

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