Management of Lower Punctal Stenosis.

• ClinicalTrials.gov Identifier: NCT03731143
• Recruitment Status: Completed
• First Posted: November 6, 2018
• Last Update Posted: November 6, 2018
• Sponsor: Menoufia University
• Information provided by (Responsible Party): Sameh S. Mandour, Menoufia University

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.

Condition or disease	Intervention/treatment	Phase
Epiphora	Procedure: insertion of self retaining bicanalicular stent	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Simple Surgical Approach for the Management of Acquired Severe Lower Punctual Stenosis
• Actual Study Start Date: January 12, 2014
• Actual Primary Completion Date: January 12, 2018
• Actual Study Completion Date: January 12, 2018

Arms and Interventions

Arm

Intervention/treatment

Experimental: study arm; surgical opening the lower punctum using the pig tail probe and a scalpel followed by insertion of self retaining bicanalicular stent (FCI®; Paris, France).

Procedure: insertion of self retaining bicanalicular stent; 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

Outcome Measures

Primary Outcome Measures :

1. Degree of improvement of epiphora by Munk score [ Time Frame: 1 year ]

   Measurement of improvement of epiphora by use of Munk score as follow Grade Clinical finding 0 No Epiphora.

   1. Occasional epiphora requiring drying or dabbing less than twice a day.
   2. Epiphora requiring dabbing two to four times per day.
   3. Epiphora requiring dabbing five to ten times per day.
   4. Epiphora requiring dabbing more than ten times daily or constant tearing.
2. Degree of improvement of lacrimal drainage by Dye disappearance test [ Time Frame: 1 year ]

   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

   1. <3
   2. 3-5
   3. >5
3. Slit lamp assesment of the state of the lower punctum [ Time Frame: 1 year ]

   Slit lamp examination of the lower punctum and its grading according to Kashkouli scale as follows:

   Grade Clinical Findings 0 No punctum (agenesis)

   1. Papilla is covered with a membrane (difficult to recognize)
   2. Less than normal size, but recognizable
   3. Normal
   4. Small slit (<2 mm)
   5. Large slit (≤2 mm

Eligibility Criteria

• Ages Eligible for Study: 17 Years to 67 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Sponsors and Collaborators

Menoufia University

Investigators

• Principal Investigator: Sameh S Mandour, MD; Menoufia Fculty of Medicine

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Sameh S. Mandour, Assistant Professor of Ophthalmology., Menoufia University
• ClinicalTrials.gov Identifier: NCT03731143
• Other Study ID Numbers: 446H/2013
• First Posted: November 6, 2018
• Last Update Posted: November 6, 2018
• Last Verified: November 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sameh S. Mandour, Menoufia University:

pigtail; punctal stenosis; bicanalicular

Additional relevant MeSH terms:

Lacrimal Apparatus Diseases; Constriction, Pathologic; Pathological Conditions, Anatomical; Eye Diseases