Functional Epiphora (Tearing Without Any Anatomical Block)NCT04952454
Functional Epiphora Management Via Different Dacryocystorhinostomy (DCR) Techniques
A study testing External Dacryocystorhinostomy, Endonasal Dacryocystorhinostomy and Transcanalicular Dacryocystorhinostomy in people with Functional Epiphora (Tearing Without Any Anatomical Block), run by Istanbul University at 2 sites in 2 countries.
Trial summary
135 eyes of 135 patients treated between 2005 and 2017 will be included in this study. The diagnosis of functional epiphora was made based on a patent lacrimal system with a delay in the fluorescein dye disappearance test (FDDT) or dacryoscintigraphy (DSG) without any ocular surface or eyelid abnormalities. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Functional Epiphora (Tearing Without Any Anatomical Block)
- What is being tested?
- External Dacryocystorhinostomy, Endonasal Dacryocystorhinostomy and Transcanalicular Dacryocystorhinostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 May 2021to 1 Jun 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 21 years and older
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patent lacrimal irrigation and delay in the lacrimal transit time demonstrated by fluorescein dye disappearance test (FDDT) or a dacryoscintigraphy (DSG)
Who cannot join
- Dry eye (tear break up time less than 10 seconds), ocular surface disorders, eyelid malposition or laxity, orbicularis weakness, partial block or stenosis of the lacrimal drainage, history of previous nasal, lacrimal, or ophthalmic surgeries, and a postoperative follow-up time less than six months
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Non-endoscopic Endonasal, Transcanalicular, or External Dacryocystorhinostomy for Functional Epiphora: Which is Better?
135 eyes of 135 patients treated between 2005 and 2017 will be included in this study. The diagnosis of functional epiphora was made based on a patent lacrimal system with a delay in the fluorescein dye disappearance test (FDDT) or dacryoscintigraphy (DSG) without any ocular surface or eyelid abnormalities. The absence of epiphora and normalization of FDDT postoperatively was defined as success. The study's hypothesis is that external DCR with a suitable technique will have better results compared to endonasal and transcanalicular DCR
- Being tested
- External Dacryocystorhinostomy, Endonasal Dacryocystorhinostomy, Transcanalicular Dacryocystorhinostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External DacryocystorhinostomyProcedure or surgery
The resistance of the lacrimal drainage is lowered by creating a new ostium between the lacrimal sac and nasal cavity via skin incision.
Endonasal DacryocystorhinostomyProcedure or surgery
The resistance of the lacrimal drainage is lowered by creating a new ostium between the lacrimal sac and nasal cavity via endonasal route.
Transcanalicular DacryocystorhinostomyProcedure or surgery
The resistance of the lacrimal drainage is lowered by creating a new ostium between the lacrimal sac and nasal cavity via transcanalicular route.
| Study group | Role | What they receive |
|---|---|---|
| External DCR | Active comparator | Patients treated with External DCR for functional epiphora Receives: Procedure: External Dacryocystorhinostomy |
| Endonasal DCR | Active comparator | Patients treated with Endonasal DCR for functional epiphora Receives: Procedure: Endonasal Dacryocystorhinostomy |
| Transcanalicular DCR | Active comparator | Patients treated with Transcanalicular DCR for functional epiphora Receives: Procedure: Transcanalicular Dacryocystorhinostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who report resolution of theri tearing and normalization of fluorescein dye disappearance test.
Measured: Last follow-up time, approximately 6 months
Secondary outcomes (1)
Number of patients who have continuing epiphora after the surgery with an anatomically blocked tear duct.
Measured: Last follow-up time, approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start1 May 2021
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Epiphora (Tearing Without Any Anatomical Block)Studies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Can Ozturker, Istanbul University
- Investigators
- Can Ozturker, MD, Study director, Istanbul University, Istanbul Facukty Of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952454
- Sponsor's protocol ID
- 1533-2020
- Status last verified
- Jul 2021
- First submitted
- 1 Jul 2021
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-endoscopic Endonasal, Transcanalicular, or External Dacryocystorhinostomy for Functional Epiphora: Which is Better?
- ClinicalTrials.gov ID
- NCT04952454
- Acronym / sponsor ID
- 1533-2020
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 7 Jul 2021 (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.
135 eyes of 135 patients treated between 2005 and 2017 will be included in this study. The diagnosis of functional epiphora was made based on a patent lacrimal system with a delay in the fluorescein dye disappearance test (FDDT) or dacryoscintigraphy (DSG) without any ocular surface or eyelid abnormalities. The absence of epiphora and normalization of FDDT postoperatively was defined as success. The study's hypothesis is that external DCR with a suitable technique will have better results compared to endonasal and transcanalicular DCR
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| External DCR | Active comparator | Procedure: External DacryocystorhinostomyPatients treated with External DCR for functional epiphora |
| Endonasal DCR | Active comparator | Procedure: Endonasal DacryocystorhinostomyPatients treated with Endonasal DCR for functional epiphora |
| Transcanalicular DCR | Active comparator | Procedure: Transcanalicular DacryocystorhinostomyPatients treated with Transcanalicular DCR for functional epiphora |
Who may qualify
- Ages
- 21 years and older
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patent lacrimal irrigation and delay in the lacrimal transit time demonstrated by fluorescein dye disappearance test (FDDT) or a dacryoscintigraphy (DSG)
Key exclusion criteria (1 listed)
- Dry eye (tear break up time less than 10 seconds), ocular surface disorders, eyelid malposition or laxity, orbicularis weakness, partial block or stenosis of the lacrimal drainage, history of previous nasal, lacrimal, or ophthalmic surgeries, and a postoperative follow-up time less than six months
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 |
|---|---|---|
| External DacryocystorhinostomyThe resistance of the lacrimal drainage is lowered by creating a new ostium between the lacrimal sac and nasal cavity via skin incision. | Procedure or surgery | External DCR |
| Endonasal DacryocystorhinostomyThe resistance of the lacrimal drainage is lowered by creating a new ostium between the lacrimal sac and nasal cavity via endonasal route. | Procedure or surgery | Endonasal DCR |
| Transcanalicular DacryocystorhinostomyThe resistance of the lacrimal drainage is lowered by creating a new ostium between the lacrimal sac and nasal cavity via transcanalicular route. | Procedure or surgery | Transcanalicular DCR |
Primary outcome
Percentage of patients who report resolution of theri tearing and normalization of fluorescein dye disappearance test.
Time frame: Last follow-up time, approximately 6 months
1 secondary outcome
Number of patients who have continuing epiphora after the surgery with an anatomically blocked tear duct.
Time frame: Last follow-up time, approximately 6 months
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 Jul 2021.
- Individual participant dataSharing planned: No
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.
Can Ozturker, MD study director
Istanbul University, Istanbul Facukty Of Medicine
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External Dacryocystorhinostomy, Endonasal Dacryocystorhinostomy and Transcanalicular Dacryocystorhinostomy in people with Functional Epiphora (Tearing Without Any Anatomical Block), run by Istanbul University at 2 sites in 2 countries.
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 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, Turkey (Türkiye). 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?
Percentage of patients who report resolution of theri tearing and normalization of fluorescein dye disappearance test. (time frame: Last follow-up time, approximately 6 months). 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 7 Jul 2021.