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Clinical Study of Lacrimal Drainage Obstruction Diseases Using Dacryoendoscopy

Primary Purpose

Lacrimal Duct Obstruction

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dacryoendoscopic-assisted laser dacryoplasty with silicone intubation
Sponsored by
Tianjin Eye Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lacrimal Duct Obstruction focused on measuring Lacrimal Duct Obstruction, Dacryoendoscopy, Dacryoplasty

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: (1) confirmed diagnosis of nasolacrimal duct obstruction or stenosis, based on dacryoendoscopic examination with or without radiologic confirmation on dacryocystogram; (2) recurrent or persistent and symptomatic epiphora; (3) follow-up of longer than 6 months after removal of the silicone stent. Exclusion Criteria: (1) congenital or traumatic lacrimal duct obstruction; (2) previous acute dacryocystitis; (3) facial nerve palsy; (4) lower eyelid or punctal malposition or laxity of sufficient severity to contribute to epiphora; (5) previous dacryocystorhinostomy; (6) incomplete medical records.

Sites / Locations

  • Tianjin Eye HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

group A

group B

group C

Arm Description

group A higher nasolacrimal duct obstruction

group B: lower nasolacrimal duct obstruction

group C: nasolacrimal duct stenosis

Outcomes

Primary Outcome Measures

Cumulative success rate
The main outcome measure was the cumulative success rate of DLDI within 2 years follow-up of obtained using the Kaplan-Meier estimator.

Secondary Outcome Measures

Full Information

First Posted
August 13, 2023
Last Updated
August 13, 2023
Sponsor
Tianjin Eye Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05999058
Brief Title
Clinical Study of Lacrimal Drainage Obstruction Diseases Using Dacryoendoscopy
Official Title
Clinical Characteristics and Treatment Outcomes of Nasolacrimal Duct Obstruction Using Dacryoendoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Eye Hospital

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
Nasolacrimal duct obstruction (NLDO) can manifest as epiphora or recurrent infections with mucopurulent discharge and may even cause social embarrassment. Dacryoendoscopic-assisted laser dacryoplasty with silicone intubation (DLDI) offers direct therapy to the obstructed site, leading to minimal collateral damage external to the target zone. Although the silicone intubation using dacryoendoscopy has increased the success rates, the success rates vary from a low of 51% to a high of 90%. The difference in success rates seems to depend on the site of obstruction, differences in the surgical technique, stringency of definitions of success, and duration of follow-up. The aim of our study was to report the results of DLDI for the management of NLDO, and to identify factors associated with DLDI failure.
Detailed Description
Lacrimal drainage obstruction can manifest as epiphora or recurrent infections with mucopurulent discharge and may even cause social embarrassment. Obstruction can occur at any level along the lacrimal drainage system: punctum, canaliculus, nasolacrimal duct, or nasal ostium. It is seen more often in females, especially in postmenopausal women. The etiopathogenesis of lacrimal passage obstruction appears to be multifactorial. Chronic inflammation has been suggested to be the most causal. Dacryocystorhinostomy (DCR) is a standard surgical procedure used to treat nasolacrimal duct obstruction (NLDO), with a reported success rate of more than 90%. Knowledge concerning the morphological characteristics of lacrimal passage obstruction using traditional diagnostic methods (e.g., lacrimal irrigation, probing, dacryocystography) is limited. Dacryoendoscopy was originally described in 1979 and has recently matured for use in lacrimal drainage system imaging. It has been proved to be a useful instrument not only for understanding differences in the etiology of obstructions but also for treating LD obstructions. On the other hand, semiconductor diode laser can achieve more effective tissue dissection than direct probing technique with minimal hemorrhage and improved intraoperative view. Hence, dacryoendoscopic-assisted laser dacryoplasty with silicone intubation (DLDI) offers direct therapy to the obstructed site, leading to minimal collateral damage external to the target zone. In addition, this procedure can be performed under local anesthesia as an outpatient procedure in the office, and it has advantages such as short surgery time and less risk of bleeding during surgery, resulting in its increasingly widespread use in China. Although the silicone intubation using dacryoendoscopy has increased the success rates, the success rates vary from a low of 51% to a high of 90%. The difference in success rates seems to depend on the site of obstruction, differences in the surgical technique, stringency of definitions of success, and duration of follow-up. A greater understanding of factors associated with treatment failure may allow us to glean insights regarding patient selection and ultimately improve treatment outcome. The aim of our study was to report the results of DLDI for the management of NLDO, and to identify factors associated with DLDI failure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lacrimal Duct Obstruction
Keywords
Lacrimal Duct Obstruction, Dacryoendoscopy, Dacryoplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
522 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Active Comparator
Arm Description
group A higher nasolacrimal duct obstruction
Arm Title
group B
Arm Type
Experimental
Arm Description
group B: lower nasolacrimal duct obstruction
Arm Title
group C
Arm Type
Experimental
Arm Description
group C: nasolacrimal duct stenosis
Intervention Type
Procedure
Intervention Name(s)
Dacryoendoscopic-assisted laser dacryoplasty with silicone intubation
Intervention Description
The dacryoendoscopy was inserted into the lacrimal duct through the upper or lower lacrimal punctum. When the dacryoendoscopy reached the postsaccal obstruction, laser dacryoplasty (FOX diode laser, A.R.C. Laser, Nürnberg, Germany) was performed by widening the stenotic or obstructed section. After removing the dacryoendoscopy, a silicone tube inserted into lacrimal passage. Double bicanalicular silicone intubation was performed as previously described.
Primary Outcome Measure Information:
Title
Cumulative success rate
Description
The main outcome measure was the cumulative success rate of DLDI within 2 years follow-up of obtained using the Kaplan-Meier estimator.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: (1) confirmed diagnosis of nasolacrimal duct obstruction or stenosis, based on dacryoendoscopic examination with or without radiologic confirmation on dacryocystogram; (2) recurrent or persistent and symptomatic epiphora; (3) follow-up of longer than 6 months after removal of the silicone stent. Exclusion Criteria: (1) congenital or traumatic lacrimal duct obstruction; (2) previous acute dacryocystitis; (3) facial nerve palsy; (4) lower eyelid or punctal malposition or laxity of sufficient severity to contribute to epiphora; (5) previous dacryocystorhinostomy; (6) incomplete medical records.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongxun Li, MD
Phone
+86 18722665027
Email
lihongxun_0522@163.com
Facility Information:
Facility Name
Tianjin Eye Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chenshu Bo, MD
Phone
+86 02227313336
Email
sykyykjk@tj.gov.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical Study of Lacrimal Drainage Obstruction Diseases Using Dacryoendoscopy

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