NCT06226181

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 26, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

January 26, 2024

Status Verified

January 1, 2024

Enrollment Period

1.1 years

First QC Date

January 17, 2024

Last Update Submit

January 17, 2024

Conditions

Nasolacrimal Duct ObstructionDacryocystorhinostomy

Keywords

Nasolacrimal Duct ObstructionDacryocystorhinostomyAmniotic Membrane

Outcome Measures

Primary Outcomes (6)

  • Functional success rate

    Clinical evidence of epiphora

    Pretreatment

  • Functional success rate

    Clinical evidence of epiphora

    1 day after surgery

  • Functional success rate

    Clinical evidence of epiphora

    1 week after surgery

  • Functional success rate

    Clinical evidence of epiphora

    3 weeks after surgery

  • Functional success rate

    Clinical evidence of epiphora

    3 months after surgery

  • Functional success rate

    Clinical evidence of epiphora

    6 months after surgery

Secondary Outcomes (8)

  • Osteotomy aspect

    1 day after surgery

  • Osteotomy aspect

    6 months after surgery

  • Nasolacrimal duct permeability

    1 week after surgery

  • Nasolacrimal duct permeability

    3 weeks after surgery

  • Nasolacrimal duct permeability

    3 months after surgery

  • +3 more secondary outcomes

Other Outcomes (1)

  • Visual acuity

    6 months after surgery

Study Arms (2)

Conventional dacryocystorhinostomy

ACTIVE COMPARATOR

Patients undergoing conventional dacryocystorhinostomy using external approach.

Procedure: Conventional dacryocystorhinostomy

Dacryocystorhinostomy using amniotic membrane

EXPERIMENTAL

Patients undergoing conventional dacryocystorhinostomy using external approach and adding amniotic membrane over the osteotomy, fixed with sutures.

Procedure: Dacryocystorhinostomy and amniotic membrane

Interventions

Dacryocystorhinostomy and amniotic membranePROCEDURE

Dacryocystorhinostomy surgery with amniotic membrane placement on the osteotomy site.

Dacryocystorhinostomy using amniotic membrane
Conventional dacryocystorhinostomyPROCEDURE

Conventional dacryocystorhinostomy surgery without adding amniotic membrane

Conventional dacryocystorhinostomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institiuto de Oftalmología Fundación Conde de Valenciana

Mexico City, 06800, Mexico

RECRUITING

Related Publications (13)

  • 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.

    PMID: 18427633BACKGROUND

  • 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.

    PMID: 27986382BACKGROUND

  • 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.

    PMID: 21821190BACKGROUND

  • 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.

    PMID: 24354575BACKGROUND

  • 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.

    PMID: 23387450BACKGROUND

  • 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.

    PMID: 25525327BACKGROUND

  • 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.

    PMID: 11151233BACKGROUND

  • 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.

    PMID: 10906101BACKGROUND

  • 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.

    PMID: 26044474BACKGROUND

  • 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.

    PMID: 21505532BACKGROUND

  • 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.

    PMID: 26675894BACKGROUND

  • 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.

    PMID: 21436959BACKGROUND

  • 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.

    PMID: 15986275BACKGROUND

MeSH Terms

Conditions

Lacrimal Duct Obstruction

Interventions

Dacryocystorhinostomy

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, OperativeOstomy

Central Study Contacts

Yonathan Garfias, MD, PhD

CONTACT

+52(55)54421700yogarfias@institutodeoftalmologia.org

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2024

First Posted

January 26, 2024

Study Start

January 1, 2024

Primary Completion

February 1, 2025

Study Completion

March 1, 2025

Last Updated

January 26, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)