Amniotic Membrane for Dacryocystorhinostomy

Nasolacrimal Duct Obstruction Clinical Trial

— AMDCRex  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06226181
• Other study ID #: CI-028-2017
• Status: Recruiting
• Phase: Phase 1
• Start date: January 1, 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: January 2024
• Source: Instituto de Oftalmología Fundación Conde de Valenciana
• Contact: Yonathan Garfias, MD, PhD
• Phone: +52(55)54421700
• Email: yogarfias[@]institutodeoftalmologia.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: March 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dacryocystorhinostomy
• Lacrimal Duct Obstruction
• Nasolacrimal Duct Obstruction

Intervention

Procedure:
• Dacryocystorhinostomy and amniotic membrane
Dacryocystorhinostomy surgery with amniotic membrane placement on the osteotomy site.
• Conventional dacryocystorhinostomy
Conventional dacryocystorhinostomy surgery without adding amniotic membrane

Locations

Country	Name	City	State
Mexico	Institiuto de Oftalmología Fundación Conde de Valenciana	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Oftalmología Fundación Conde de Valenciana

Country where clinical trial is conducted

Mexico, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. Erratum In: Orbit. 2013 Jun;32(3):217. Erlich, Joshua [corrected to Ehrlich, Joshua R]. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Visual acuity	Best corrected visual acuity	6 months after surgery
Primary	Functional success rate	Clinical evidence of epiphora	Pretreatment
Primary	Functional success rate	Clinical evidence of epiphora	1 day after surgery
Primary	Functional success rate	Clinical evidence of epiphora	1 week after surgery
Primary	Functional success rate	Clinical evidence of epiphora	3 weeks after surgery
Primary	Functional success rate	Clinical evidence of epiphora	3 months after surgery
Primary	Functional success rate	Clinical evidence of epiphora	6 months after surgery
Secondary	Osteotomy aspect	Endonasal aspect of osteotomy	1 day after surgery
Secondary	Osteotomy aspect	Endonasal aspect of osteotomy	6 months after surgery
Secondary	Nasolacrimal duct permeability	Permeability of nasolacrimal duct tested by canaliculi irrigation	1 week after surgery
Secondary	Nasolacrimal duct permeability	Permeability of nasolacrimal duct tested by canaliculi irrigation	3 weeks after surgery
Secondary	Nasolacrimal duct permeability	Permeability of nasolacrimal duct tested by canaliculi irrigation	3 months after surgery
Secondary	Nasolacrimal duct permeability	Permeability of nasolacrimal duct tested by canaliculi irrigation	6 months after surgery
Secondary	Visual acuity	Best corrected visual acuity	Pre treatment
Secondary	Surgical Complications	Adverse events or unadvertised complications at the time of the surgery	At the date of surgery