Management of Lower Punctal Stenosis.

NCT03731143 | Completed

• 1 other identifier: 446H/2013
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Epiphora

Keywords

pigtail; punctal stenosis; bicanalicular

Outcome Measures

Primary Outcomes (3)

• 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. 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.

  1 year

• 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 1. \<3 2. 3-5 3. \>5

  1 year

• 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) 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

  1 year

Study Arms (1)

study arm

EXPERIMENTAL

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

Interventions

insertion of self retaining bicanalicular stent PROCEDURE

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

study arm

Eligibility Criteria

• Age: 17 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• severe lowee punctual stenosis
• patent upper punctum and canaliculus as well as patent nasolacrimal duct
• normal lower eyelid margin position -

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menoufia University: lead

Related Publications (1)

• 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.

  PMID: 30733874 DERIVED

MeSH Terms

Conditions

Lacrimal Apparatus Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Sameh S Mandour, MD

  Menoufia Fculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Ophthalmology.

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: November 6, 2018
• Study Start: January 12, 2014
• Primary Completion: January 12, 2018
• Study Completion: January 12, 2018
• Last Updated: November 6, 2018

Record last verified: 2018-11