Management of Lower Punctal Stenosis.
Primary Purpose
Epiphora
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
insertion of self retaining bicanalicular stent
Sponsored by
About this trial
This is an interventional treatment trial for Epiphora focused on measuring pigtail, punctal stenosis, bicanalicular
Eligibility Criteria
Inclusion Criteria:
- severe lowee punctual stenosis
- patent upper punctum and canaliculus as well as patent nasolacrimal duct
- normal lower eyelid margin position -
Exclusion Criteria:
- patients with punctal stenosis with grades more than 0 according to Kashkouli scale
- patients with previous eyelid surgery
- a lump overlying or involving the punctum or other part of the tear drainage system.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
study arm
Arm Description
surgical opening the lower punctum using the pig tail probe and a scalpel followed by insertion of self retaining bicanalicular stent (FCI®; Paris, France).
Outcomes
Primary Outcome Measures
Degree of improvement of epiphora by Munk score
Measurement of improvement of epiphora by use of Munk score as follow Grade Clinical finding 0 No Epiphora.
Occasional epiphora requiring drying or dabbing less than twice a day.
Epiphora requiring dabbing two to four times per day.
Epiphora requiring dabbing five to ten times per day.
Epiphora requiring dabbing more than ten times daily or constant tearing.
Degree of improvement of lacrimal drainage by Dye disappearance test
measurement of improvement by using the dye disappearance test. It was performed by putting a drop of 2% fluorescein sodium in the conjunctival sac followed by assessment after 5 minutes of the remaining dye in the tear meniscus. Results were graded according to the following scale
Grade Dye disappearance time, min
<3
3-5
>5
Slit lamp assesment of the state of the lower punctum
Slit lamp examination of the lower punctum and its grading according to Kashkouli scale as follows:
Grade Clinical Findings 0 No punctum (agenesis)
Papilla is covered with a membrane (difficult to recognize)
Less than normal size, but recognizable
Normal
Small slit (<2 mm)
Large slit (≤2 mm
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03731143
Brief Title
Management of Lower Punctal Stenosis.
Official Title
A Simple Surgical Approach for the Management of Acquired Severe Lower Punctual Stenosis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 12, 2014 (Actual)
Primary Completion Date
January 12, 2018 (Actual)
Study Completion Date
January 12, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menoufia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
a prospective non-randomized study conducted upon 24 patients with severe lower punctual stenosis (grade 0 according to Kashkouli scale) attending at Menoufia University hospitals. The upper punctum and canaliculus were patent. All patients were complaining of epiphora and had a thorough ophthalmological examination including dye disappearance test, and slit-lamp examination. Pigtail probe was used from patent upper punctum to detect the lower stenosed punctum which was opened with a scalpel. Syringing of the lower lacrimal passages was done to confirm its patency and self retaining silicone bicanalicular stent was inserted. The silicone tube was left in place for 6 months before it was removed. Patients were then followed up for 1 year after the surgery.
Detailed Description
This is a prospective non-randomized study which was conducted upon 24 patients with total lower punctual occlusion attending at Menoufia University hospitals in the period from January 2014 to January 2018. Ethics approval from the institutional review board was obtained, and a written informed consent was taken from every patient according to the Declaration of Helsinki.
All patients of the study were complaining of epiphora and had a thorough ophthalmological examination including dye disappearance test, and slit-lamp examination. The dye disappearance test was performed with a drop of 2% fluorescein sodium and assessment after 5 minutes of the remaining dye in the tear meniscus was done and results were graded.
Surgical procedure
All operations were done under general anesthesia and were performed by two authors (SSM, KES). The authors performed lacrimal probing and syringing test through the normal punctum to exclude concomitant occluded common canaliculus or nasolacrimal duct. The pigtail probe was passed through the canalicular system from the normal punctum to the occluded aspect. When the tip of the pigtail probe was positioned near the occluded punctal area, the surgeon pushed the area to be tented with the pigtail probe. After they advanced the pigtail probe back and forth several times until they could locate the correct position of the occluded punctum, the authors incised the tented area with a scalpel No. 11 to make a new punctal opening.
To ensure punctal and canalicular patency, syringing was repeated through the perforated punctum. To prevent re-occlusion of punctal opening, a self retaining bicanalicular tube (FCI®; Paris, France) was inserted through the normal and perforated puncti.
The silicone tube was left in place for 6 months before it was removed. Patients were then followed up for 1 year after the surgery (6 months after removal of the tube). During the follow-up period, the authors investigated the improvement of subjective epiphora symptoms based on Munk score, fluorescein disappearance test, maintenance of newly formed punctal opening, and incidence of complications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epiphora
Keywords
pigtail, punctal stenosis, bicanalicular
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study arm
Arm Type
Experimental
Arm Description
surgical opening the lower punctum using the pig tail probe and a scalpel followed by insertion of self retaining bicanalicular stent (FCI®; Paris, France).
Intervention Type
Procedure
Intervention Name(s)
insertion of self retaining bicanalicular stent
Intervention Description
The pigtail probe was passed through the canalicular system from the normal punctum to the occluded aspect. When the tip of the pigtail probe was positioned near the occluded punctal area, the surgeon pushed the area to be tented with the pigtail probe. After they advanced the pigtail probe back and forth several times until they could locate the correct position of the occluded punctum, the authors incised the tented area with a scalpel No. 11 to make a new punctal opening.
To ensure punctal and canalicular patency, syringing was repeated through the perforated punctum. To prevent re-occlusion of punctal opening, a self retaining bicanalicular tube (FCI®; Paris, France) was inserted through the normal and perforated puncti
Primary Outcome Measure Information:
Title
Degree of improvement of epiphora by Munk score
Description
Measurement of improvement of epiphora by use of Munk score as follow Grade Clinical finding 0 No Epiphora.
Occasional epiphora requiring drying or dabbing less than twice a day.
Epiphora requiring dabbing two to four times per day.
Epiphora requiring dabbing five to ten times per day.
Epiphora requiring dabbing more than ten times daily or constant tearing.
Time Frame
1 year
Title
Degree of improvement of lacrimal drainage by Dye disappearance test
Description
measurement of improvement by using the dye disappearance test. It was performed by putting a drop of 2% fluorescein sodium in the conjunctival sac followed by assessment after 5 minutes of the remaining dye in the tear meniscus. Results were graded according to the following scale
Grade Dye disappearance time, min
<3
3-5
>5
Time Frame
1 year
Title
Slit lamp assesment of the state of the lower punctum
Description
Slit lamp examination of the lower punctum and its grading according to Kashkouli scale as follows:
Grade Clinical Findings 0 No punctum (agenesis)
Papilla is covered with a membrane (difficult to recognize)
Less than normal size, but recognizable
Normal
Small slit (<2 mm)
Large slit (≤2 mm
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
severe lowee punctual stenosis
patent upper punctum and canaliculus as well as patent nasolacrimal duct
normal lower eyelid margin position -
Exclusion Criteria:
patients with punctal stenosis with grades more than 0 according to Kashkouli scale
patients with previous eyelid surgery
a lump overlying or involving the punctum or other part of the tear drainage system.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh S Mandour, MD
Organizational Affiliation
Menoufia Fculty of Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30733874
Citation
Mandour SS, Said-Ahmed KE, Khairy HA, Elsawy MF, Zaky MA. A Simple Surgical Approach for the Management of Acquired Severe Lower Punctal Stenosis. J Ophthalmol. 2019 Jan 14;2019:3561857. doi: 10.1155/2019/3561857. eCollection 2019.
Results Reference
derived
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Management of Lower Punctal Stenosis.
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