search
Back to results

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
Menoufia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epiphora focused on measuring pigtail, punctal stenosis, bicanalicular

Eligibility Criteria

17 Years - 67 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. severe lowee punctual stenosis
  2. patent upper punctum and canaliculus as well as patent nasolacrimal duct
  3. normal lower eyelid margin position -

Exclusion Criteria:

  1. patients with punctal stenosis with grades more than 0 according to Kashkouli scale
  2. patients with previous eyelid surgery
  3. 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

    First Posted
    October 26, 2018
    Last Updated
    November 2, 2018
    Sponsor
    Menoufia University
    search

    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

    Learn more about this trial

    Management of Lower Punctal Stenosis.

    We'll reach out to this number within 24 hrs