Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06428266
Status:
COMPLETED
Last Update Posted:
2024-05-31
First Post:
2024-05-20
Brief Title:
Closed Dacryointubation vs Bicanalicular Intubation for Proximal Tear Duct Obstruction
Sponsor:
Instituto de Oftalmología Fundación Conde de Valenciana
Organization:
Instituto de Oftalmología Fundación Conde de Valenciana
Study Overview
Official Title:
Comparative Study of Safety and Efficacy of Closed Dacryointubation vs Bicanalicular Intubation in the Treatment of Proximal Tear Duct Obstruction in Adult Patients
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DICvsBIcanal
Brief Summary:
In Mexico upper lacrimal duct obstruction ULDO is a common pathology and the standard surgical treatment is closed dracryointubation Based on statistics from our headquarters in 30 of cases there is a failure of the technique and recurrence of symptoms due to associated complications Because of this the application of a self-stable bicananlicular intubation set is proposed The aim of this study is to describe the difference in efficacy and complication rate between the application of the self-stable bicanalicular intubation set II FCI and closed dacryointubation in patients with ULDO
Detailed Description:
Upper lacrimal duct obstruction ULDO or proximal lacrimal tract obstruction occurs when an occlusion is located in the lacrimal point in superior and inferior canaliculi or in the common canaliculus When the ULDO is at the level of the canaliculi superior inferior or common the alternatives available for its management are closed dacryointubation with Crowford catheter conjunctivadacryocystorhinostomy and bicanalicular intubation
Closed dacryointubation with Crowford tube is a technique effective in approximately 90 of children diagnosed with congenital occlusion of the lacrimal duct however in adults the reported surgical success rate is lower approximately 70 according to different authors
The conjunctivadacryocystorhinostomy is the procedure proposed by many authors when there is point and canaliculi obstruction in which canalicular intubation cannot be performed due to atresia or total obstruction
The bicanaliculalr intubation with the Self-Stable Canalicular Intubation Set FCI R an FDA-approved silicone bicanalicular retention device is especially indicated for the treatment of lacrimal point stenosis and horizontal canalicular obstruction
The aim of this study is to describe the difference in efficacy and complication rate between the application of the self-stable bicanalicular intubation set II ICF and closed dacryointubation in patients with ULDO
Closed dacryointubation with Crowford tube is a technique effective in approximately 90 of children diagnosed with congenital occlusion of the lacrimal duct however in adults the reported surgical success rate is lower approximately 70 according to different authors
The conjunctivadacryocystorhinostomy is the procedure proposed by many authors when there is point and canaliculi obstruction in which canalicular intubation cannot be performed due to atresia or total obstruction
The bicanaliculalr intubation with the Self-Stable Canalicular Intubation Set FCI R an FDA-approved silicone bicanalicular retention device is especially indicated for the treatment of lacrimal point stenosis and horizontal canalicular obstruction
The aim of this study is to describe the difference in efficacy and complication rate between the application of the self-stable bicanalicular intubation set II ICF and closed dacryointubation in patients with ULDO
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None