Lacrimal Duct ObstructionNCT00571129
Endoscopic Dacryocystorhinostomy Prospective Research
A study testing DCR with no tubes or mitomycin in people with Lacrimal Duct Obstruction, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
Endoscopic dacryocystorhinostomy (EN-DCR) is an effective procedure when treating saccal and postsaccal obstructions of the nasolacrimal pathway. The benefit of silicone tubing after DCR is still controversial. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lacrimal Duct Obstruction
- What is being tested?
- DCR with no tubes or mitomycin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2004to Dec 2021
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (age > 18), ASAI-III, and were scheduled for primary or revision lacrimal pathway surgery due to recurrent or chronic watering eyes or conjunctival discharge.
- Patients were excluded if they had previous nasolacrimal surgery, malignancy in the paranasal sinuses, nasal cavity, or lacrimal pathway, presaccal obstruction, pregnancy or lactation, or mental disability.
Who cannot join
- Malignancy in the paranasal sinuses, nasal cavity, or lacrimal pathway, presaccal obstruction, pregnancy or lactation, or mental disability.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Recovery After Endoscopic Dacryocystorhinostomy
Endoscopic dacryocystorhinostomy (EN-DCR) is an effective procedure when treating saccal and postsaccal obstructions of the nasolacrimal pathway. The benefit of silicone tubing after DCR is still controversial. We conducted a prospective, randomized study in order to evaluate 1) the necessity of bicanalicular silicone tubes after primary EN-DCR, 2) efficacy of the perioperative Mitomycin C for the prevention of adheesion and re-stenosis of rhinostomy site in revision EN-DCR, 3) the subjective symptoms and QoL changes before and after DCR-operation.
- Conditions
- Lacrimal Duct Obstruction
- Being tested
- DCR with no tubes or mitomycin
- Keywords
- Primary,silicone tube,revision,mitomycin C,endoscopic DCR
- 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.
DCR with no tubes or mitomycinProcedure or surgery
Also called DCR with tubes or mitomycin
The patients were randomized into the two study groups, either with or without the insertion of a bicanalicular silicone tube after primary DCR.
In revision group patients were randomized into the two groups,ether with or without application of mitomycin "C" after DCR
| Study group | Role | What they receive |
|---|---|---|
| with tubes or mitomycin | Active comparator | After DCR bicanalicular tubes were inserted After re-DCR mitomycin in cottonpads were placed into rhinostoma for 5 minutes Receives: Procedure: DCR with no tubes or mitomycin |
| without tubes or mitomycin | Active comparator | After DCR no tubes were inserted After re-DCR no mitomycin was used Receives: Procedure: DCR with no tubes or mitomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success rate after primary DCR with and without silicone tubes. The success rate after revisio DCR with and without Mitomycin C.
Measured: 5 years
Secondary outcomes (1)
The EN-DCR operation influence on the patients subjective symptoms and QoL before and after operation.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2007 (estimated)
- Study startSep 2004
- Primary completionDec 2011
- Study completionDec 2021 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- DCR with/ without tubes Revision DCR with/ without mitomycin
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juha Seppa, Kuopio University Hospital
- Investigators
- Juha Seppä, MD,PhD, Study chair, Kuopio University Hospital, Otorhinolaryngology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00571129
- Sponsor's protocol ID
- KUH5551812
- Other IDs
- 255104
- Status last verified
- Feb 2020
- First submitted
- 10 Dec 2007
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Penttila E, Hyttinen JM, Hytti M, Kauppinen A, Smirnov G, Tuomilehto H, Seppa J, Nuutinen J, Kaarniranta K. Upregulation of inflammatory genes in the nasal mucosa of patients undergoing endonasal dacryocystorhinostomy. Clin Ophthalmol. 2014 Apr 25;8:799-805. doi: 10.2147/OPTH.S50195. eCollection 2014.
PubMed 24851037
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery After Endoscopic Dacryocystorhinostomy
- ClinicalTrials.gov ID
- NCT00571129
- Acronym / sponsor ID
- KUH5551812
- Conditions
- Lacrimal Duct Obstruction
- Keywords
- Primary,silicone tube,revision,mitomycin C,endoscopic DCR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- Sep 2004 (actual)
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2021 (estimated)
- First posted
- 11 Dec 2007 (estimated)
- 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.
Endoscopic dacryocystorhinostomy (EN-DCR) is an effective procedure when treating saccal and postsaccal obstructions of the nasolacrimal pathway. The benefit of silicone tubing after DCR is still controversial. We conducted a prospective, randomized study in order to evaluate 1) the necessity of bicanalicular silicone tubes after primary EN-DCR, 2) efficacy of the perioperative Mitomycin C for the prevention of adheesion and re-stenosis of rhinostomy site in revision EN-DCR, 3) the subjective symptoms and QoL changes before and after DCR-operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- DCR with/ without tubes Revision DCR with/ without mitomycin
| Arm | Type | Receives |
|---|---|---|
| with tubes or mitomycin | Active comparator | Procedure: DCR with no tubes or mitomycinAfter DCR bicanalicular tubes were inserted After re-DCR mitomycin in cottonpads were placed into rhinostoma for 5 minutes |
| without tubes or mitomycin | Active comparator | Procedure: DCR with no tubes or mitomycinAfter DCR no tubes were inserted After re-DCR no mitomycin was used |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults (age > 18), ASAI-III, and were scheduled for primary or revision lacrimal pathway surgery due to recurrent or chronic watering eyes or conjunctival discharge.
- Patients were excluded if they had previous nasolacrimal surgery, malignancy in the paranasal sinuses, nasal cavity, or lacrimal pathway, presaccal obstruction, pregnancy or lactation, or mental disability.
Key exclusion criteria (1 listed)
- Malignancy in the paranasal sinuses, nasal cavity, or lacrimal pathway, presaccal obstruction, pregnancy or lactation, or mental disability.
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 |
|---|---|---|
| DCR with no tubes or mitomycinAlso: DCR with tubes or mitomycinThe patients were randomized into the two study groups, either with or without the insertion of a bicanalicular silicone tube after primary DCR. In revision group patients were randomized into the two groups,ether with or without application of mitomycin "C" after DCR | Procedure or surgery | with tubes or mitomycin, without tubes or mitomycin |
Primary outcome
The success rate after primary DCR with and without silicone tubes. The success rate after revisio DCR with and without Mitomycin C.
Time frame: 5 years
1 secondary outcome
The EN-DCR operation influence on the patients subjective symptoms and QoL before and after operation.
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Background: PubMed 24851037Penttila E, Hyttinen JM, Hytti M, Kauppinen A, Smirnov G, Tuomilehto H, Seppa J, Nuutinen J, Kaarniranta K. Upregulation of inflammatory genes in the nasal mucosa of patients undergoing endonasal dacryocystorhinostomy. Clin Ophthalmol. 2014 Apr 25;8:799-805. doi: 10.2147/OPTH.S50195. eCollection 2014.
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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.
Juha Seppä, MD,PhD study chair
Kuopio University Hospital, Otorhinolaryngology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DCR with no tubes or mitomycin in people with Lacrimal Duct Obstruction, run by Kuopio University Hospital at 1 site in Finland.
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 2 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: status not confirmed, as of the sponsor's last update on 25 Feb 2020. 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 Finland. 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?
Results are not available in the source record.
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?
The success rate after primary DCR with and without silicone tubes. The success rate after revisio DCR with and without Mitomycin C. (time frame: 5 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 NCT00571129, 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 25 Feb 2020.