Congenital Nasolacrimal Duct ObstructionNCT02081781
The Factors That Affected the Outcome of Treatment of Congenital Nasolacrimal Duct Obstruction
An observational study of Congenital Nasolacrimal Duct Obstruction, run by Cathay General Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study was to investigate various potential factors that affected the outcome of treatment of congenital nasolacrimal duct obstruction. Read more about this study
- Who is it for?
- Ages 1 week to 5 years
- Conditions the study is for
- Congenital Nasolacrimal Duct Obstruction
- What is being tested?
- Probing
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 800 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2014to Mar 2014
- Phase
- Observational
- 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 1 week to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: primary care clinic
Who may be able to join
- a history of tearing and/or mucopurulent discharge beginning during the first few weeks of life
- anatomical nasolacrimal duct obstruction
Who cannot join
- previous probing
- glaucoma
- trauma
- lid malpositions
- craniofacial anomalies
- congenital mucocele of the nasolacrimal sac
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Ophthalmology, Cathay General Hospital
Taipei, Taiwan, 106
About this study
Official title: Case Control Study of the Factors That Affected the Outcome of Treatment of Congenital Nasolacrimal Duct Obstruction
The purpose of this study was to investigate various potential factors that affected the outcome of treatment of congenital nasolacrimal duct obstruction.
Read the detailed description
Congenital nasolacrimal duct obstruction is a common condition during the first few years of childhood. Most cases may resolve spontaneously, but the remaining children whose blockage does not resolve may require primary probing. Controversy remains regarding the optimal timing of the probing procedure. Another controversy is related to the setting of surgery. Therefore, we try to investigate the factors that affected the outcome of treatment of congenital nasolacrimal duct obstruction under the same surgical doctor during the past 13 years in our hospital.
- Conditions
- Congenital Nasolacrimal Duct Obstruction
- Being tested
- Probing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbingProcedure or surgery
A punctal dilator was used for dilating the punctum. The nasolacrimal system was irrigated through either the lower or upper punctum with a hollow 23-gauge irrigating cannula attached to a syringe. A #0 (or #00) Bowman probe was passed through either the lower or upper canaliculus into the lacrimal sac and then directed downward through the nasolacrimal duct into nasal cavity. A "Hard" resistance could be felt as the probe touched the end of the nasolacrimal duct. A "Pop" tactile sensation might be noted while the probe passing through an obstruction at the valve of Hasner.
| Study group | Role | What they receive |
|---|---|---|
| Probing, topical anesthesia | Nasolacrimal duct obstruction (NLDO) is a quite common condition among the infants. An imperforate membrane at the distal end of the nasolacrimal duct is the main cause of occlusion. Children with the signs of NLDO presenting with epiphora and/or mucous discharge were included in this study. Intervention with probing under topical anesthesia was performed on the same surgeon. And success rate was evaluated. Receives: Procedure: Probing |
What is being measured
The primary outcome is the main question the study is designed to answer.
probing success: both anatomical patency of the duct and functional free of symptoms
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Congenital Nasolacrimal 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cathay General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chih Heng Hung, M.D., Principal investigator, Department of Ophthalmology, Cathay General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02081781
- Sponsor's protocol ID
- CGH-P103002
- Status last verified
- Mar 2014
- First submitted
- 5 Mar 2014
- Last updated
- 7 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Pediatric Eye Disease Investigator Group; Repka MX, Chandler DL, Beck RW, Crouch ER 3rd, Donahue S, Holmes JM, Lee K, Melia M, Quinn GE, Sala NA, Schloff S, Silbert DI, Wallace DK. Primary treatment of nasolacrimal duct obstruction with probing in children younger than 4 years. Ophthalmology. 2008 Mar;115(3):577-584.e3. doi: 10.1016/j.ophtha.2007.07.030. Epub 2007 Nov 8.
PubMed 17996306Miller AM, Chandler DL, Repka MX, Hoover DL, Lee KA, Melia M, Rychwalski PJ, Silbert DI; Pediatric Eye Disease Investigator Group; Beck RW, Crouch ER 3rd, Donahue S, Holmes JM, Quinn GE, Sala NA, Schloff S, Wallace DK, Foster NC, Frick KD, Golden RP, Lambert SR, Tien DR, Weakley DR Jr. Office probing for treatment of nasolacrimal duct obstruction in infants. J AAPOS. 2014 Feb;18(1):26-30. doi: 10.1016/j.jaapos.2013.10.016.
PubMed 24568978
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case Control Study of the Factors That Affected the Outcome of Treatment of Congenital Nasolacrimal Duct Obstruction
- ClinicalTrials.gov ID
- NCT02081781
- Acronym / sponsor ID
- CGH-P103002
- Conditions
- Congenital Nasolacrimal Duct Obstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Cathay General HospitalUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 7 Mar 2014 (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.
The purpose of this study was to investigate various potential factors that affected the outcome of treatment of congenital nasolacrimal duct obstruction.
Detailed description
Congenital nasolacrimal duct obstruction is a common condition during the first few years of childhood. Most cases may resolve spontaneously, but the remaining children whose blockage does not resolve may require primary probing. Controversy remains regarding the optimal timing of the probing procedure. Another controversy is related to the setting of surgery. Therefore, we try to investigate the factors that affected the outcome of treatment of congenital nasolacrimal duct obstruction under the same surgical doctor during the past 13 years in our hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Probing, topical anesthesia | – | Procedure: ProbingNasolacrimal duct obstruction (NLDO) is a quite common condition among the infants. An imperforate membrane at the distal end of the nasolacrimal duct is the main cause of occlusion. Children with the signs of NLDO presenting with epiphora and/or mucous discharge were included in this study. Intervention with probing under topical anesthesia was performed on the same surgeon. And success rate was evaluated. |
Who may qualify
- Ages
- 1 week to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- primary care clinic
Key inclusion criteria (2 listed)
- a history of tearing and/or mucopurulent discharge beginning during the first few weeks of life
- anatomical nasolacrimal duct obstruction
Key exclusion criteria (6 listed)
- previous probing
- glaucoma
- trauma
- lid malpositions
- craniofacial anomalies
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 |
|---|---|---|
| ProbingA punctal dilator was used for dilating the punctum. The nasolacrimal system was irrigated through either the lower or upper punctum with a hollow 23-gauge irrigating cannula attached to a syringe. A #0 (or #00) Bowman probe was passed through either the lower or upper canaliculus into the lacrimal sac and then directed downward through the nasolacrimal duct into nasal cavity. A "Hard" resistance could be felt as the probe touched the end of the nasolacrimal duct. A "Pop" tactile sensation might be noted while the probe passing through an obstruction at the valve of Hasner. | Procedure or surgery | Probing, topical anesthesia |
Primary outcome
probing success: both anatomical patency of the duct and functional free of symptoms
Time frame: one week
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 7 Mar 2014.
- Background: PubMed 17996306Pediatric Eye Disease Investigator Group; Repka MX, Chandler DL, Beck RW, Crouch ER 3rd, Donahue S, Holmes JM, Lee K, Melia M, Quinn GE, Sala NA, Schloff S, Silbert DI, Wallace DK. Primary treatment of nasolacrimal duct obstruction with probing in children younger than 4 years. Ophthalmology. 2008 Mar;115(3):577-584.e3. doi: 10.1016/j.ophtha.2007.07.030. Epub 2007 Nov 8.
- Background: PubMed 24568978Miller AM, Chandler DL, Repka MX, Hoover DL, Lee KA, Melia M, Rychwalski PJ, Silbert DI; Pediatric Eye Disease Investigator Group; Beck RW, Crouch ER 3rd, Donahue S, Holmes JM, Quinn GE, Sala NA, Schloff S, Wallace DK, Foster NC, Frick KD, Golden RP, Lambert SR, Tien DR, Weakley DR Jr. Office probing for treatment of nasolacrimal duct obstruction in infants. J AAPOS. 2014 Feb;18(1):26-30. doi: 10.1016/j.jaapos.2013.10.016.
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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.
Chih Heng Hung, M.D. principal investigator
Department of Ophthalmology, Cathay General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Nasolacrimal Duct Obstruction, run by Cathay General Hospital at 1 site in Taiwan.
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 6 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 7 Mar 2014. 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 Taiwan. 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?
probing success: both anatomical patency of the duct and functional free of symptoms (time frame: one week). 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 NCT02081781, which also lists 2 linked publications.
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 7 Mar 2014.