Clinical Study of Lacrimal Drainage Obstruction Diseases Using Dacryoendoscopy

Clinical Characteristics and Treatment Outcomes of Nasolacrimal Duct Obstruction Using Dacryoendoscopy

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.

Study Overview

• Status: Completed
• Conditions: Lacrimal Duct Obstruction
• Intervention / Treatment: Procedure: Dacryoendoscopic-assisted laser dacryoplasty with silicone intubation

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.

• Study Type: Interventional
• Enrollment (Actual): 522
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300020
      • TianJin eye hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group A; group A higher nasolacrimal duct obstruction	Procedure: Dacryoendoscopic-assisted laser dacryoplasty with silicone intubation; 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.
Experimental: group B; group B: lower nasolacrimal duct obstruction	Procedure: Dacryoendoscopic-assisted laser dacryoplasty with silicone intubation; 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.
Experimental: group C; group C: nasolacrimal duct stenosis	Procedure: Dacryoendoscopic-assisted laser dacryoplasty with silicone intubation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Collaborators and Investigators

• Sponsor: Tianjin Eye Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): November 1, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: August 13, 2023
• First Submitted That Met QC Criteria: August 13, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 25, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Lacrimal Duct Obstruction; Dacryoendoscopy; Dacryoplasty
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Lacrimal Duct Obstruction
• Other Study ID Numbers: KY-2023038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No