Nasolacrimal Duct Obstruction Clinical Trial
— AMDCRexOfficial 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.
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 |
Country | Name | City | State |
---|---|---|---|
Mexico | Institiuto de Oftalmología Fundación Conde de Valenciana | Mexico City |
Lead Sponsor | Collaborator |
---|---|
Instituto de Oftalmología Fundación Conde de Valenciana |
Mexico,
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
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 |
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