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This study aims to compare the success rate of external dacryocystorhinostomy with and without amniotic membranes in patients with nasolacrimal duct obstruction.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional dacryocystorhinostomy | Active Comparator | Patients undergoing conventional dacryocystorhinostomy using external approach. |
|
| Dacryocystorhinostomy using amniotic membrane | Experimental | Patients undergoing conventional dacryocystorhinostomy using external approach and adding amniotic membrane over the osteotomy, fixed with sutures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dacryocystorhinostomy and amniotic membrane | Procedure | Dacryocystorhinostomy surgery with amniotic membrane placement on the osteotomy site. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Osteotomy aspect | Endonasal aspect of osteotomy | 1 day after surgery |
| Osteotomy aspect | Endonasal aspect of osteotomy | 6 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity | Best corrected visual acuity | 6 months after surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yonathan Garfias, MD, PhD | Contact | +52(55)54421700 | 3207 | yogarfias@institutodeoftalmologia.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institiuto de OftalmologÃa Fundación Conde de Valenciana | Recruiting | Mexico City | 06800 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18427633 | Background | 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. | |
| 27986382 | Background | 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. |
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| ID | Term |
|---|---|
| D007767 | Lacrimal Duct Obstruction |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D003608 | Dacryocystorhinostomy |
| ID | Term |
|---|---|
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D010030 | Ostomy |
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| Conventional dacryocystorhinostomy | Procedure | Conventional dacryocystorhinostomy surgery without adding amniotic membrane |
|
| Nasolacrimal duct permeability | Permeability of nasolacrimal duct tested by canaliculi irrigation | 1 week after surgery |
| Nasolacrimal duct permeability | Permeability of nasolacrimal duct tested by canaliculi irrigation | 3 weeks after surgery |
| Nasolacrimal duct permeability | Permeability of nasolacrimal duct tested by canaliculi irrigation | 3 months after surgery |
| Nasolacrimal duct permeability | Permeability of nasolacrimal duct tested by canaliculi irrigation | 6 months after surgery |
| Visual acuity | Best corrected visual acuity | Pre treatment |
| Surgical Complications | Adverse events or unadvertised complications at the time of the surgery | At the date of surgery |
| 21821190 | Background | 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. |
| 24354575 | Background | 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. |
| 23387450 | Background | 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. |
| 25525327 | Background | 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. |
| 11151233 | Background | 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. |
| 10906101 | Background | 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. |
| 26044474 | Background | 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. |
| 21505532 | Background | 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. |
| 26675894 | Background | 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. |
| 21436959 | Background | 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. |
| 15986275 | Background | 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. |