跳至主要内容
临床试验/NCT03731143
NCT03731143已完成不适用

A Simple Surgical Approach for the Management of Acquired Severe Lower Punctual Stenosis

Menoufia University0 个研究点目标入组 24 人开始时间: 2014年1月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
主要终点
Slit lamp assesment of the state of the lower punctum

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
17 Years 至 67 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

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).

干预措施: insertion of self retaining bicanalicular stent (Procedure)

结局指标

主要结局

Slit lamp assesment of the state of the lower punctum

时间窗: 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

Degree of improvement of epiphora by Munk score

时间窗: 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.

Degree of improvement of lacrimal drainage by Dye disappearance test

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sameh S. Mandour

Assistant Professor of Ophthalmology.

Menoufia University

相似试验

Management of Lower Punctal Stenosis. | 临床试验