Congenital Nasolacrimal Duct ObstructionPhase 2/3NCT04148170
Recanalization of Congenital Nasolacrimal Duct Obstruction by Endodiathermy Probe and Intubation Versus Intubation Only
A Phase 2/3 study testing Endodiathermy Probe and Intubation Versus Intubation in people with Congenital Nasolacrimal Duct Obstruction, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of the current work is to assess the efficiency and success rate of endodiathermy probe followed by intubation in children more than 2 years compared to the success rate of intubation (as a standard method) which varies from 75% to 85% in several studies Read more about this study
- Who is it for?
- Ages 2 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Congenital Nasolacrimal Duct Obstruction
- What is being tested?
- Endodiathermy Probe and Intubation Versus Intubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2020to Sep 2020
- Phase
- Phase 2/3
- 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 2 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children in the age group above 2 years old
- No history of previous probing.
- No history of previous intubation.
- Children with no any other association or congenital anomalies cause watery eye.
- children suffer from congenital nasolacrimal duct obstruction.
Who cannot join
- children less than 2 years old.
- previous probing.
- previous intubation.
- children with any other congenital anomalies as congenital ectropion , congenital entropion
- children suffer from any upper lacrimal anomalies as obstruction or stenosis.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Abo El Resh Pedriatric Hospital Cairo University
Cairo, 31111
karim bakr, lecture, 00201144008882, kemos1984@yahoo.com
About this study
The purpose of the current work is to assess the efficiency and success rate of endodiathermy probe followed by intubation in children more than 2 years compared to the success rate of intubation (as a standard method) which varies from 75% to 85% in several studies
Read the detailed description
The study will be conducted on children above 2 year and will be divided randomly into two groups:
Group (I): 80 eyes of children suffer from congenital nasolacrimal duct obstruction will have probing with metal probe and then intubation with bicanlicular silicon tube.
Group (II): 80 eyes of children suffer from congenital nasolacrimal duct obstruction will have probing with endodiathermy probe and then intubation with bicanlicular silicon tube
- Conditions
- Congenital Nasolacrimal Duct Obstruction
- Being tested
- Endodiathermy Probe and Intubation Versus Intubation
- Keywords
- Endodiathermy Probe and Intubation Versus Intubation Only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endodiathermy Probe and Intubation Versus IntubationProcedure or surgery
children suffer from congenital nasolacrimal duct obstruction will have probing with endodiathermy probe and then intubation with bicanlicular silicon tube
| Study group | Role | What they receive |
|---|---|---|
| classic intubation | Active comparator | children suffer from congenital nasolacrimal duct obstruction will have probing with metal probe and then intubation with bicanlicular silicon tube. Receives: Procedure: Endodiathermy Probe and Intubation Versus Intubation |
| endodiathermy probe | Active comparator | children suffer from congenital nasolacrimal duct obstruction will have probing with endodiathermy probe and then intubation with bicanlicular silicon tube Receives: Procedure: Endodiathermy Probe and Intubation Versus Intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
recanalization of nasolacrimal duct
compare the efficiency of endodiathermy probe followed by intubation versus probing with metal probe followed by intubation by
- epiphora (overflow of tears onto the face)
- increase tear film meniscus ( more than 1mm in height)
- mucous discharge
- Fluorescein disappearance test (Normally, little or no dye remains after 5 minutes. Prolonged retention is indicative of inadequate lacrimal drainage)
Measured: 6 months
Secondary outcomes (1)
complication
Record any complication in two procedures as tube migration, tube extrusion, infection or need for additional procedure.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study startMar 2020 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionSep 2020 (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 Congenital Nasolacrimal Duct ObstructionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group (I): 80 eyes of children suffer from congenital nasolacrimal duct obstruction will have probing with metal probe and then intubation with bicanlicular silicon tube. Group (II): 80 eyes of children suffer from congenital nasolacrimal duct obstruction will have probing with endodiathermy probe and then intubation with bicanlicular silicon tube.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Hassan Abdelbaky, Cairo University
- Investigators
- tamer gawdat, professor, Principal investigator, professor of ophthalmology cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148170
- Sponsor's protocol ID
- Cairo118988
- Status last verified
- Oct 2019
- First submitted
- 27 Oct 2019
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: after finishiny my research can share my data
Publications
Suranagi PV, Poornima MS; Smruthi; Banagar B. Regarding a novel technique to recanalize the nasolacrimal duct with endodiathermy bipolar probe. Indian J Ophthalmol. 2014 Sep;62(9):971. doi: 10.4103/0301-4738.143956. No abstract available.
PubMed 25370408
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recanalization of Congenital Nasolacrimal Duct Obstruction by Endodiathermy Probe and Intubation Versus Intubation Only
- ClinicalTrials.gov ID
- NCT04148170
- Acronym / sponsor ID
- Cairo118988
- Conditions
- Congenital Nasolacrimal Duct Obstruction
- Keywords
- Endodiathermy Probe and Intubation Versus Intubation Only
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2020 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 1 Nov 2019 (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.
The purpose of the current work is to assess the efficiency and success rate of endodiathermy probe followed by intubation in children more than 2 years compared to the success rate of intubation (as a standard method) which varies from 75% to 85% in several studies
Detailed description
The study will be conducted on children above 2 year and will be divided randomly into two groups:
Group (I): 80 eyes of children suffer from congenital nasolacrimal duct obstruction will have probing with metal probe and then intubation with bicanlicular silicon tube.
Group (II): 80 eyes of children suffer from congenital nasolacrimal duct obstruction will have probing with endodiathermy probe and then intubation with bicanlicular silicon tube
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Group (I): 80 eyes of children suffer from congenital nasolacrimal duct obstruction will have probing with metal probe and then intubation with bicanlicular silicon tube. Group (II): 80 eyes of children suffer from congenital nasolacrimal duct obstruction will have probing with endodiathermy probe and then intubation with bicanlicular silicon tube.
| Arm | Type | Receives |
|---|---|---|
| classic intubation | Active comparator | Procedure: Endodiathermy Probe and Intubation Versus Intubationchildren suffer from congenital nasolacrimal duct obstruction will have probing with metal probe and then intubation with bicanlicular silicon tube. |
| endodiathermy probe | Active comparator | Procedure: Endodiathermy Probe and Intubation Versus Intubationchildren suffer from congenital nasolacrimal duct obstruction will have probing with endodiathermy probe and then intubation with bicanlicular silicon tube |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children in the age group above 2 years old
- No history of previous probing.
- No history of previous intubation.
- Children with no any other association or congenital anomalies cause watery eye.
- children suffer from congenital nasolacrimal duct obstruction.
Key exclusion criteria (5 listed)
- children less than 2 years old.
- previous probing.
- previous intubation.
- children with any other congenital anomalies as congenital ectropion , congenital entropion
- children suffer from any upper lacrimal anomalies as obstruction or stenosis.
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 |
|---|---|---|
| Endodiathermy Probe and Intubation Versus Intubationchildren suffer from congenital nasolacrimal duct obstruction will have probing with endodiathermy probe and then intubation with bicanlicular silicon tube | Procedure or surgery | classic intubation, endodiathermy probe |
Primary outcome
recanalization of nasolacrimal duct
Time frame: 6 months
compare the efficiency of endodiathermy probe followed by intubation versus probing with metal probe followed by intubation by 1. epiphora (overflow of tears onto the face) 2. increase tear film meniscus ( more than 1mm in height) 3. mucous discharge 4. Fluorescein disappearance test (Normally, little or no dye remains after 5 minutes. Prolonged retention is indicative of inadequate lacrimal drainage)
1 secondary outcome
complication
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Results publication: PubMed 25370408Suranagi PV, Poornima MS; Smruthi; Banagar B. Regarding a novel technique to recanalize the nasolacrimal duct with endodiathermy bipolar probe. Indian J Ophthalmol. 2014 Sep;62(9):971. doi: 10.4103/0301-4738.143956. No abstract available.
- Individual participant dataSharing planned: Yes. after finishiny my research can share my data
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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.
tamer gawdat, professor principal investigator
professor of ophthalmology cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Endodiathermy Probe and Intubation Versus Intubation in people with Congenital Nasolacrimal Duct Obstruction, run by Cairo University at 1 site in Egypt.
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 5 inclusion and 5 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 1 Nov 2019. 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 Egypt. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact mohamed hafez ibrahim (00201224010523, monsieur84@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recanalization of nasolacrimal duct (time frame: 6 months). 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 NCT04148170, 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 1 Nov 2019.