Lacrimal MucoceleNCT03176355
Intraoperative Mitomycin C in Lacrimal Sac Mucocele
A study testing Canaliculo- Dacryocystorhinostomy in people with Lacrimal Mucocele, run by Minia University.
Trial summary
30 patients had lacrimal sac mucocele and dacryocystorhinostomy was done for them with intraoperative mitomycin C was added to decrease postoperative fibrosis and recurrence. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Lacrimal Mucocele
- What is being tested?
- Canaliculo- Dacryocystorhinostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 23 Mar 2011to 7 Jan 2013
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lacrimal sac mucocele
Who cannot join
- Paediatric patients (less than 16 years old).
- Previous lacrimal passage procedure.
- Neoplasms as secondary causes of obstruction.
About this study
Official title: Evaluation of Intraoperative Mitomycin C in Surgical Management of Lacrimal Sac Mucocele
30 patients had lacrimal sac mucocele and dacryocystorhinostomy was done for them with intraoperative mitomycin C was added to decrease postoperative fibrosis and recurrence.
- Conditions
- Lacrimal Mucocele
- Being tested
- Canaliculo- Dacryocystorhinostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canaliculo- DacryocystorhinostomyProcedure or surgery
Bypass lacrimal passage obstruction by opening a shunt between the lacrimal sac and the nasal mucosa
| Study group | Role | What they receive |
|---|---|---|
| Chronic dacryocystitis patients | Other | Not described Receives: Procedure: Canaliculo- Dacryocystorhinostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disappearance of the watering of the eye reported by the patients and by fluorescein disappearance test
Patency of the lacrimal passage
Measured: 1 month
Disappearance of lacrimal sac swelling
No evident swelling in the medial side of the eye
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start23 Mar 2011
- Primary completion7 Jan 2012
- Study completion7 Jan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lacrimal MucoceleStudies of the same condition, open and under way.
- More trials run by Minia 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Farag Khalil Ibrahiem, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176355
- Sponsor's protocol ID
- Minia Hospital
- Status last verified
- Jun 2017
- First submitted
- 28 May 2017
- Last updated
- 5 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intraoperative Mitomycin C in Surgical Management of Lacrimal Sac Mucocele
- ClinicalTrials.gov ID
- NCT03176355
- Acronym / sponsor ID
- Minia Hospital
- Conditions
- Lacrimal Mucocele
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 23 Mar 2011 (actual)
- Primary completion
- 7 Jan 2012 (actual)
- Study completion
- 7 Jan 2013 (actual)
- First posted
- 5 Jun 2017 (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.
30 patients had lacrimal sac mucocele and dacryocystorhinostomy was done for them with intraoperative mitomycin C was added to decrease postoperative fibrosis and recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic dacryocystitis patients | Other | Procedure: Canaliculo- Dacryocystorhinostomy |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Lacrimal sac mucocele
Key exclusion criteria (3 listed)
- Paediatric patients (less than 16 years old).
- Previous lacrimal passage procedure.
- Neoplasms as secondary causes of obstruction.
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 |
|---|---|---|
| Canaliculo- DacryocystorhinostomyBypass lacrimal passage obstruction by opening a shunt between the lacrimal sac and the nasal mucosa | Procedure or surgery | Chronic dacryocystitis patients |
Primary outcome
Disappearance of the watering of the eye reported by the patients and by fluorescein disappearance test
Time frame: 1 month
Patency of the lacrimal passage
Disappearance of lacrimal sac swelling
Time frame: 1 month
No evident swelling in the medial side of the eye
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 5 Jun 2017.
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.
Questions about this trial
What is this clinical trial studying?
A study testing Canaliculo- Dacryocystorhinostomy in people with Lacrimal Mucocele, run by Minia University.
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 3 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 5 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Disappearance of the watering of the eye reported by the patients and by fluorescein disappearance test (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2017.