Lacrimal Duct ObstructionNCT05999058
Clinical Study of Lacrimal Drainage Obstruction Diseases Using Dacryoendoscopy
A study testing Dacryoendoscopic-assisted laser dacryoplasty with silicone intubation in people with Lacrimal Duct Obstruction, run by Tianjin Eye Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lacrimal Duct Obstruction
- What is being tested?
- Dacryoendoscopic-assisted laser dacryoplasty with silicone intubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 522 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2019to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Lacrimal Duct Obstruction
- Being tested
- Dacryoendoscopic-assisted laser dacryoplasty with silicone intubation
- Keywords
- Lacrimal Duct Obstruction, Dacryoendoscopy, Dacryoplasty
- Medical subject headings
- Lacrimal Duct Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dacryoendoscopic-assisted laser dacryoplasty with silicone intubationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | group A higher nasolacrimal duct obstruction Receives: Procedure: Dacryoendoscopic-assisted laser dacryoplasty with silicone intubation |
| group B | Experimental | group B: lower nasolacrimal duct obstruction Receives: Procedure: Dacryoendoscopic-assisted laser dacryoplasty with silicone intubation |
| group C | Experimental | group C: nasolacrimal duct stenosis Receives: Procedure: Dacryoendoscopic-assisted laser dacryoplasty with silicone intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Nov 2019
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lacrimal Duct ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 522 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05999058
- Sponsor's protocol ID
- KY-2023038
- Status last verified
- Nov 2023
- First submitted
- 13 Aug 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39486803
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics and Treatment Outcomes of Nasolacrimal Duct Obstruction Using Dacryoendoscopy
- ClinicalTrials.gov ID
- NCT05999058
- Acronym / sponsor ID
- KY-2023038
- Conditions
- Lacrimal Duct Obstruction
- Keywords
- Lacrimal Duct Obstruction, Dacryoendoscopy, Dacryoplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 522 participants (actual)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Procedure: Dacryoendoscopic-assisted laser dacryoplasty with silicone intubationgroup A higher nasolacrimal duct obstruction |
| group B | Experimental | Procedure: Dacryoendoscopic-assisted laser dacryoplasty with silicone intubationgroup B: lower nasolacrimal duct obstruction |
| group C | Experimental | Procedure: Dacryoendoscopic-assisted laser dacryoplasty with silicone intubationgroup C: nasolacrimal duct stenosis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dacryoendoscopic-assisted laser dacryoplasty with silicone intubationThe 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. | Procedure or surgery | group A, group B, group C |
Primary outcome
Cumulative success rate
Time frame: 2 years
The main outcome measure was the cumulative success rate of DLDI within 2 years follow-up of obtained using the Kaplan-Meier estimator.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Derived from this study: PubMed 39486803Li 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dacryoendoscopic-assisted laser dacryoplasty with silicone intubation in people with Lacrimal Duct Obstruction, run by Tianjin Eye Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative success rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05999058, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.