Nctid:
NCT06226181
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000007767", "term"=>"Lacrimal Duct Obstruction"}], "ancestors"=>[{"id"=>"D000007766", "term"=>"Lacrimal Apparatus Diseases"}, {"id"=>"D000005128", "term"=>"Eye Diseases"}], "browseLeaves"=>[{"id"=>"M10787", "name"=>"Lacrimal Duct Obstruction", "asFound"=>"Nasolacrimal Duct Obstruction", "relevance"=>"HIGH"}, {"id"=>"M10786", "name"=>"Lacrimal Apparatus Diseases", "relevance"=>"LOW"}, {"id"=>"M8271", "name"=>"Eye Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Eye Diseases", "abbrev"=>"BC11"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["PARTICIPANT", "INVESTIGATOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>32}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-01-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2025-03-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-17", "studyFirstSubmitDate"=>"2024-01-17", "studyFirstSubmitQcDate"=>"2024-01-17", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-02-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"Visual acuity", "timeFrame"=>"6 months after surgery", "description"=>"Best corrected visual acuity"}], "primaryOutcomes"=>[{"measure"=>"Functional success rate", "timeFrame"=>"Pretreatment", "description"=>"Clinical evidence of epiphora"}, {"measure"=>"Functional success rate", "timeFrame"=>"1 day after surgery", "description"=>"Clinical evidence of epiphora"}, {"measure"=>"Functional success rate", "timeFrame"=>"1 week after surgery", "description"=>"Clinical evidence of epiphora"}, {"measure"=>"Functional success rate", "timeFrame"=>"3 weeks after surgery", "description"=>"Clinical evidence of epiphora"}, {"measure"=>"Functional success rate", "timeFrame"=>"3 months after surgery", "description"=>"Clinical evidence of epiphora"}, {"measure"=>"Functional success rate", "timeFrame"=>"6 months after surgery", "description"=>"Clinical evidence of epiphora"}], "secondaryOutcomes"=>[{"measure"=>"Osteotomy aspect", "timeFrame"=>"1 day after surgery", "description"=>"Endonasal aspect of osteotomy"}, {"measure"=>"Osteotomy aspect", "timeFrame"=>"6 months after surgery", "description"=>"Endonasal aspect of osteotomy"}, {"measure"=>"Nasolacrimal duct permeability", "timeFrame"=>"1 week after surgery", "description"=>"Permeability of nasolacrimal duct tested by canaliculi irrigation"}, {"measure"=>"Nasolacrimal duct permeability", "timeFrame"=>"3 weeks after surgery", "description"=>"Permeability of nasolacrimal duct tested by canaliculi irrigation"}, {"measure"=>"Nasolacrimal duct permeability", "timeFrame"=>"3 months after surgery", "description"=>"Permeability of nasolacrimal duct tested by canaliculi irrigation"}, {"measure"=>"Nasolacrimal duct permeability", "timeFrame"=>"6 months after surgery", "description"=>"Permeability of nasolacrimal duct tested by canaliculi irrigation"}, {"measure"=>"Visual acuity", "timeFrame"=>"Pre treatment", "description"=>"Best corrected visual acuity"}, {"measure"=>"Surgical Complications", "timeFrame"=>"At the date of surgery", "description"=>"Adverse events or unadvertised complications at the time of the surgery"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Nasolacrimal Duct Obstruction", "Dacryocystorhinostomy", "Amniotic Membrane"], "conditions"=>["Nasolacrimal Duct Obstruction", "Dacryocystorhinostomy"]}, "referencesModule"=>{"references"=>[{"pmid"=>"18427633", "type"=>"BACKGROUND", "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."}, {"pmid"=>"27986382", "type"=>"BACKGROUND", "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."}, {"pmid"=>"21821190", "type"=>"BACKGROUND", "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."}, {"pmid"=>"24354575", "type"=>"BACKGROUND", "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."}, {"pmid"=>"23387450", "type"=>"BACKGROUND", "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]."}, {"pmid"=>"25525327", "type"=>"BACKGROUND", "citation"=>"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"=>"11151233", "type"=>"BACKGROUND", "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."}, {"pmid"=>"10906101", "type"=>"BACKGROUND", "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."}, {"pmid"=>"26044474", "type"=>"BACKGROUND", "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."}, {"pmid"=>"21505532", "type"=>"BACKGROUND", "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."}, {"pmid"=>"26675894", "type"=>"BACKGROUND", "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."}, {"pmid"=>"21436959", "type"=>"BACKGROUND", "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."}, {"pmid"=>"15986275", "type"=>"BACKGROUND", "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."}]}, "descriptionModule"=>{"briefSummary"=>"This study aims to compare the success rate of external dacryocystorhinostomy with and without amniotic membranes in patients with nasolacrimal duct obstruction.", "detailedDescription"=>"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.\n\nSome 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.\n\nAmniotic 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.\n\nThis study aims to compare the success rate of external DCR with and without amniotic membranes in patients with NLDO."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patients over 18 years old\n* Diagnosis of Nasolacrimal Duct Obstruction or Score ≥ 2 on the Munk Scale\n* Patients able to undergo general anesthesia\n* Patients able to keep follow-up\n* Patients willing to participate in the study and signed informed consent\n\nExclusion Criteria:\n\n* Patients with ocular surface diseases that affect surgical outcomes, such as blepharitis, lacrimal punctum epithelization, kissing punctae, facial nerve palsy, allergic conjunctivitis, etc\n* Patients with eyelid malpositions\n* Patients diagnosed with systemic inflammatory diseases, such as granulomatosis with polyangiitis, sarcoidosis, etc\n* Previous history of facial trauma with nasal bone fractures\n* Pregnancy and lactation"}, "identificationModule"=>{"nctId"=>"NCT06226181", "acronym"=>"AMDCRex", "briefTitle"=>"Amniotic Membrane for Dacryocystorhinostomy", "organization"=>{"class"=>"OTHER", "fullName"=>"Instituto de Oftalmología Fundación Conde de Valenciana"}, "officialTitle"=>"Amniotic Membrane for External Dacryocystorhinostomy and Comparison of Success Rate With Conventional Surgery for Patients With Nasolacrimal Duct Obstruction", "orgStudyIdInfo"=>{"id"=>"CI-028-2017"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"Conventional dacryocystorhinostomy", "description"=>"Patients undergoing conventional dacryocystorhinostomy using external approach.", "interventionNames"=>["Procedure: Conventional dacryocystorhinostomy"]}, {"type"=>"EXPERIMENTAL", "label"=>"Dacryocystorhinostomy using amniotic membrane", "description"=>"Patients undergoing conventional dacryocystorhinostomy using external approach and adding amniotic membrane over the osteotomy, fixed with sutures.", "interventionNames"=>["Procedure: Dacryocystorhinostomy and amniotic membrane"]}], "interventions"=>[{"name"=>"Dacryocystorhinostomy and amniotic membrane", "type"=>"PROCEDURE", "description"=>"Dacryocystorhinostomy surgery with amniotic membrane placement on the osteotomy site.", "armGroupLabels"=>["Dacryocystorhinostomy using amniotic membrane"]}, {"name"=>"Conventional dacryocystorhinostomy", "type"=>"PROCEDURE", "description"=>"Conventional dacryocystorhinostomy surgery without adding amniotic membrane", "armGroupLabels"=>["Conventional dacryocystorhinostomy"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"06800", "city"=>"Mexico City", "status"=>"RECRUITING", "country"=>"Mexico", "contacts"=>[{"name"=>"Yonathan Garfias", "role"=>"CONTACT", "email"=>"yogarfias@institutodeoftalmologia.org", "phone"=>"+525554421700", "phoneExt"=>"3702"}], "facility"=>"Institiuto de Oftalmología Fundación Conde de Valenciana", "geoPoint"=>{"lat"=>19.42847, "lon"=>-99.12766}}], "centralContacts"=>[{"name"=>"Yonathan Garfias, MD, PhD", "role"=>"CONTACT", "email"=>"yogarfias@institutodeoftalmologia.org", "phone"=>"+52(55)54421700", "phoneExt"=>"3207"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Instituto de Oftalmología Fundación Conde de Valenciana", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
