NCT05999058

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
522

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

4 years

First QC Date

August 13, 2023

Last Update Submit

November 25, 2023

Conditions

Lacrimal Duct Obstruction

Keywords

Lacrimal Duct ObstructionDacryoendoscopyDacryoplasty

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

group A

ACTIVE COMPARATOR

group A higher nasolacrimal duct obstruction

Procedure: Dacryoendoscopic-assisted laser dacryoplasty with silicone intubation

group B

EXPERIMENTAL

group B: lower nasolacrimal duct obstruction

Procedure: Dacryoendoscopic-assisted laser dacryoplasty with silicone intubation

group C

EXPERIMENTAL

group C: nasolacrimal duct stenosis

Procedure: Dacryoendoscopic-assisted laser dacryoplasty with silicone intubation

Interventions

Dacryoendoscopic-assisted laser dacryoplasty with silicone intubationPROCEDURE

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.

group Agroup Bgroup C

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Eye Hospital

Tianjin, Tianjin Municipality, 300020, China

Location

Related Publications (1)

  • Li H, Li J, Zhang L, Yang L, Zhao Y, Zhao H, Pan Y. Clinical outcomes and prognostic factors in patients with nasolacrimal duct obstruction or stenosis using dacryoendoscopy. BMJ Open Ophthalmol. 2024 Oct 31;9(1):e001743. doi: 10.1136/bmjophth-2024-001743.

    PMID: 39486803DERIVED

MeSH Terms

Conditions

Lacrimal Duct Obstruction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2023

First Posted

August 21, 2023

Study Start

November 1, 2019

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

November 28, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)