Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-31 @ 7:26 AM
Study NCT ID:
NCT04898933
Status:
COMPLETED
Last Update Posted:
2025-05-22
First Post:
2021-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lacrimal Deroofing for Epiphora From Punctal Abnormalities
Sponsor:
Benha University
Organization:
Study Overview
Official Title:
Lacrimal Deroofing for the Management of Epiphora From Lacrimal Punctal-Canalicular Abnormalities
Status:
COMPLETED
Status Verified Date:
2025-05
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:
None
Brief Summary:
Puncto-canalicular abnormalities, such as obstruction and canaliculitis, are a significant cause of epiphora. They involve proximal lacrimal drainage system. Proximal lacrimal obstructions classified into punctal stenosis canalicular obstructions. The basic principles in the treatment of punctal stenosis include creating an adequate opening, while maintaining the position of the punctum against the lacrimal lake, and preserving the lacrimal pump function. The severity of epiphora can be valued trough a grading system such as the Munk scale, fluorescein dye disappearance test, and syringing and probing and contrast dacryocystography.
Canaliculitis is defined as infection of the proximal part of the lacrimal drainage system. This condition can be caused by primary infectious organisms or secondary to punctal plugs and lacrimal stents. Diagnosing canaliculitis is frequently misdiagnosed. The management includes conservative measures, local massage, syringing, and irrigation. Nevertheless, refractory cases required surgical intervention.
Canaliculitis is defined as infection of the proximal part of the lacrimal drainage system. This condition can be caused by primary infectious organisms or secondary to punctal plugs and lacrimal stents. Diagnosing canaliculitis is frequently misdiagnosed. The management includes conservative measures, local massage, syringing, and irrigation. Nevertheless, refractory cases required surgical intervention.
Detailed Description:
Purpose: To report outcomes of proximal lacrimal deroofing in the management of proximal lacrimal drainage system abnormalities.
Inclusion criteria: At least 18 years old patients with lacrimal punctum stenosis and/or canaliculitis.
Exclusion Criteria: Trauma, Thyroid eye disease, lacrimation and other causes of epiphora.
Evaluation: All patients underwent a comprehensive ophthalmic examination, and lacrimal drainage evaluation at baseline,2 weeks and 6 months after the surgery.
Outcome Measures:
Munk scale for epiphora grading (0-5); 0 No epiphora ,1 Epiphora requiring dabbing less than twice a day, 2 Epiphora requiring dabbing 2-4 times a day, 3 Epiphora requiring dabbing 5-10 times a day, 4 Epiphora requiring dabbing more than 10 times a day, 5 Constant epiphora.
Grading of External Lacrimal Puncum (0-5); score 0: No papilla and punctum (punctal atresia); surgery to create a papilla, score1: Papilla is covered by a membrane; a #25 needle, followed by a punctal finder. Exudative or true membrane or fibrosis, difficult to recognize with standard punctum dilator, score 2: Less than normal size, but recognizable; a punctal finder and, then a standard punctum dilator required, score 3: Normal; regular punctum dilator required, score 4: Small slit (\< 2 mm); no intervention required, score 5 Large slit (≥ 2 mm); no intervention required.
Inclusion criteria: At least 18 years old patients with lacrimal punctum stenosis and/or canaliculitis.
Exclusion Criteria: Trauma, Thyroid eye disease, lacrimation and other causes of epiphora.
Evaluation: All patients underwent a comprehensive ophthalmic examination, and lacrimal drainage evaluation at baseline,2 weeks and 6 months after the surgery.
Outcome Measures:
Munk scale for epiphora grading (0-5); 0 No epiphora ,1 Epiphora requiring dabbing less than twice a day, 2 Epiphora requiring dabbing 2-4 times a day, 3 Epiphora requiring dabbing 5-10 times a day, 4 Epiphora requiring dabbing more than 10 times a day, 5 Constant epiphora.
Grading of External Lacrimal Puncum (0-5); score 0: No papilla and punctum (punctal atresia); surgery to create a papilla, score1: Papilla is covered by a membrane; a #25 needle, followed by a punctal finder. Exudative or true membrane or fibrosis, difficult to recognize with standard punctum dilator, score 2: Less than normal size, but recognizable; a punctal finder and, then a standard punctum dilator required, score 3: Normal; regular punctum dilator required, score 4: Small slit (\< 2 mm); no intervention required, score 5 Large slit (≥ 2 mm); no intervention required.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: