EpiphoraNCT04833452
Comparative Study Between Wide and Narrow Fenstrum Endoscopic DCR
A study testing Endoscopic dacryocystorhinostomy in people with Epiphora and Dacryocystitis, run by Menoufia University at 1 site in Egypt.
Trial summary
The aim of the study is to compare the efficacy and effectiveness of Endoscopic Endonasal DCR with narrow fenstrum approach and Endoscopic Endonasal DCR with wide fenstrum approach . Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epiphora, Dacryocystitis, Dacryocystocele
- What is being tested?
- Endoscopic dacryocystorhinostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Sep 2018to 18 Oct 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients presented with epiphora due to nasolacrimal duct obstruction with patent canaliculi.
- failed conservative treatment in the form of systemic antibiotics, steroid/antibiotic eye drops, decongestant nasal drops and local nasal steroid spray.
- fit for surgery under general anesthesia.
Who cannot join
- 1- Epiphora due to pre-saccal obstruction of lacrimal drainage system.
- 2. Eye disease causing increased lacrimation and eyelid malposition
- 3. Lacrimal fistula.
- 4. Tumors of the lacrimal passage, nose or paranasal sinus.
- 5. Patients with abnormal bleeding or coagulation time.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to compare the efficacy and effectiveness of Endoscopic Endonasal DCR with narrow fenstrum approach and Endoscopic Endonasal DCR with wide fenstrum approach .
Read the detailed description
The lacrimal sac and the nasolacrimal duct are contiguous structures . The part of the sac superior to the medial canthal tendon (MCT) is called the fundus, with its vertical length being 3-5 mm . The body of the sac, inferior to the MCT, is about 10 mm in length. The lacrimal sac fossa comprises of the anterior frontal process of the maxillary bone and the posterior lacrimal bone .
Lacrimal clearance relies on several factors, such as gravity, capillary attraction forces, evaporation, absorption by the conjunctival surface and the lacrimal "pump" which relies on the action of the orbicularis oculi muscle, particularly its deeper part (Horner's muscle). During the eye closing, the Horner's muscle contracts and the temporal four-fifths part of the canaliculus is pressed and closed, the nasal one-fifth part is pulled posteriorly and opens with shortening of the canalicular length. Therefore, the lacrimal fluid is effectively transported from temporal to nasal sides, finally reaching the lacrimal sac cavity. During the eye opening, as the Horner's muscle relaxes, the temporal four-fifths part of the canaliculus is expanded and the nasal one-fifth part is pressed and closed. The upper part of the lacrimal sac is directly affected by the Horner's muscle movement. During eye closing the sac expands temporally, during the eye opening the sac shrinks with an additional help of its elasticity.
The clinical evaluation of the lacrimal drainage system was originally outlined by Lester Jones. Evaluation was in the form of a dye disappearance test followed by a Jones I and Jones II test. The dye disappearance test (DDT) is useful for assessing the presence or absence of adequate lacrimal outflow, especially in unilateral cases. Using a drop of sterile 2% fluorescein solution or a moistened fluorescein strip, the examiner instills fluorescein into the conjunctival fornices of each eye and then observes the tear film.
Endoscopic DCR is a widely accepted treatment option for epiphora and dacryocystitis. endoscopic DCR has been widely performed as it has several advantages over external DCR including the absence of face scarring and better visualization via endoscopy. The purpose of DCR is to create a bypass, a rhinostoma, between the lacrimal sac and the nasal cavity.
Obstruction site in the lacrimal system is one of the characteristics contributing to a poor prognosis. False localization of the lacrimal sac and inadequate removal of the medial wall of the sac are the most common causes of failure . A systematic review showed that there was a trend towards improved outcomes and reduced granulation without increased complication rates in groups where nasal mucosal and lacrimal flaps were preserved. A study reviewing 100 failed DCR patients showed that inadequate osteotomy, incomplete sac marsupialization, and cicatricial closure of the ostium were the most common causes of failure.
To avoid or prevent obstruction of the neo-ostium, many modified techniques have been attempted. These include complete separation of the sac from the nasolacrimal duct to divert lacrimal flow to the neo-ostium, use of steroids or mitomycin-C , silicon tubing and use of mucosal flaps after wide resection of bone surrounding the sac .
Initially, endoscopic DCR relied on the creation of a relatively small fenstrum into the lacrimal sac, with the surgeon opening only the lower half of the sac. Many authors claim that the axilla of the middle turbinate is a landmark for the roof of the lacrimal sac. However, Wormald and co-authors, in a study with 47 CT-DCG patients, showed that the major part of the lacrimal sac (10 mm) is situated above the axilla of the middle turbinate, extending 1-2 mm below this landmark.
Obtaining a large marsupialized lacrimal sac with wide removal of the covering bone, medial wall of the sac and use of mucosal flaps yields a good surgical result that is comparable to the results of conventional endoscopic DCR techniques with two advantages first, primary surgical failures are amenable to technically simple and highly successful surgical revisions, second, there is a possibility for obtaining wide fenstrum without silicone tube stenting.
Success after lacrimal surgery is ill defined, and this has led to confusion in the interpretation of results for various surgical methods. The most practical measure of success is the control of symptoms, although this can be at odds with anatomic outcome.
Subjective success in turn can be assessed from the patients' symptoms. Complete relief or significant improvement of complaints can be considered a subjective success.
Anatomical patency can readily be judged in objective tests: functional endoscopic dye test or inspection of the ostium, irrigation or fluorescein retention test. Functional NLDO was first described by Demorest and Miller in 1955 to encompass lacrimal drainage dysfunction in the presence of anatomical patency. In those cases, there is a need to exclude other conditions causing epiphora, such as hyper-secretion, lacrimal pump failure, discontinuous drainage apparatus and partial lacrimal duct obstruction. The anatomical success rate i.e. the patency is reported to be higher than the functional success, which highlights the importance of measuring the physiological success and there relief of the patient's symptoms.
- Conditions
- Epiphora, Dacryocystitis, Dacryocystocele
- Being tested
- Endoscopic dacryocystorhinostomy
- Keywords
- Endoscopic DCR
- Medical subject headings
- Lacrimal Apparatus Diseases, Dacryocystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic dacryocystorhinostomyProcedure or surgery
Endoscopic DCR
| Study group | Role | What they receive |
|---|---|---|
| Wide fenstrum Endoscopic DCR | Active comparator | Not described Receives: Procedure: Endoscopic dacryocystorhinostomy |
| Narrow Fenstrum Endoscopic DCR | Active comparator | Not described Receives: Procedure: Endoscopic dacryocystorhinostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopic assessment
Measurement dimensions of the DCR ostium by measuring length and width in mile meters by using nasal endoscope
Measured: 1 year postoperative
Objective assessment
Objective assessment by flourscine disappearance test
Measured: 1 year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start18 Sep 2018
- Primary completion18 Aug 2021 (estimated)
- Study completion18 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EpiphoraStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Essam Ahmed EL-mezien, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833452
- Sponsor's protocol ID
- Endoscopic DCR
- Status last verified
- Apr 2021
- First submitted
- 1 Apr 2021
- Last updated
- 6 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bertaux PJ, Gan G, Hirtz G, Mouret P, El-Hachem F, Lhuillier L, Perone JM. Evaluation of ostium size following endoscopic dacryocystorhinostomy as a predictive factor of outcome: A prospective study. J Fr Ophtalmol. 2021 Mar;44(3):397-403. doi: 10.1016/j.jfo.2020.05.024. Epub 2020 Dec 30.
PubMed 33388192Ali MJ, Psaltis AJ, Wormald PJ. Dacryocystorhinostomy ostium: parameters to evaluate and DCR ostium scoring. Clin Ophthalmol. 2014 Dec 9;8:2491-9. doi: 10.2147/OPTH.S73998. eCollection 2014.
PubMed 25525327Mann BS, Wormald PJ. Endoscopic assessment of the dacryocystorhinostomy ostium after endoscopic surgery. Laryngoscope. 2006 Jul;116(7):1172-4. doi: 10.1097/01.mlg.0000218099.33523.19.
PubMed 16826055
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Wide and Narrow Fenstrum Endoscopic DCR
- ClinicalTrials.gov ID
- NCT04833452
- Acronym / sponsor ID
- Endoscopic DCR
- Conditions
- Epiphora, Dacryocystitis, Dacryocystocele
- Keywords
- Endoscopic DCR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 18 Aug 2021 (estimated)
- Study completion
- 18 Oct 2021 (estimated)
- First posted
- 6 Apr 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.
The aim of the study is to compare the efficacy and effectiveness of Endoscopic Endonasal DCR with narrow fenstrum approach and Endoscopic Endonasal DCR with wide fenstrum approach .
Detailed description
The lacrimal sac and the nasolacrimal duct are contiguous structures . The part of the sac superior to the medial canthal tendon (MCT) is called the fundus, with its vertical length being 3-5 mm . The body of the sac, inferior to the MCT, is about 10 mm in length. The lacrimal sac fossa comprises of the anterior frontal process of the maxillary bone and the posterior lacrimal bone .
Lacrimal clearance relies on several factors, such as gravity, capillary attraction forces, evaporation, absorption by the conjunctival surface and the lacrimal "pump" which relies on the action of the orbicularis oculi muscle, particularly its deeper part (Horner's muscle). During the eye closing, the Horner's muscle contracts and the temporal four-fifths part of the canaliculus is pressed and closed, the nasal one-fifth part is pulled posteriorly and opens with shortening of the canalicular length. Therefore, the lacrimal fluid is effectively transported from temporal to nasal sides, finally reaching the lacrimal sac cavity. During the eye opening, as the Horner's muscle relaxes, the temporal four-fifths part of the canaliculus is expanded and the nasal one-fifth part is pressed and closed. The upper part of the lacrimal sac is directly affected by the Horner's muscle movement. During eye closing the sac expands temporally, during the eye opening the sac shrinks with an additional help of its elasticity.
The clinical evaluation of the lacrimal drainage system was originally outlined by Lester Jones. Evaluation was in the form of a dye disappearance test followed by a Jones I and Jones II test. The dye disappearance test (DDT) is useful for assessing the presence or absence of adequate lacrimal outflow, especially in unilateral cases. Using a drop of sterile 2% fluorescein solution or a moistened fluorescein strip, the examiner instills fluorescein into the conjunctival fornices of each eye and then observes the tear film.
Endoscopic DCR is a widely accepted treatment option for epiphora and dacryocystitis. endoscopic DCR has been widely performed as it has several advantages over external DCR including the absence of face scarring and better visualization via endoscopy. The purpose of DCR is to create a bypass, a rhinostoma, between the lacrimal sac and the nasal cavity.
Obstruction site in the lacrimal system is one of the characteristics contributing to a poor prognosis. False localization of the lacrimal sac and inadequate removal of the medial wall of the sac are the most common causes of failure . A systematic review showed that there was a trend towards improved outcomes and reduced granulation without increased complication rates in groups where nasal mucosal and lacrimal flaps were preserved. A study reviewing 100 failed DCR patients showed that inadequate osteotomy, incomplete sac marsupialization, and cicatricial closure of the ostium were the most common causes of failure.
To avoid or prevent obstruction of the neo-ostium, many modified techniques have been attempted. These include complete separation of the sac from the nasolacrimal duct to divert lacrimal flow to the neo-ostium, use of steroids or mitomycin-C , silicon tubing and use of mucosal flaps after wide resection of bone surrounding the sac .
Initially, endoscopic DCR relied on the creation of a relatively small fenstrum into the lacrimal sac, with the surgeon opening only the lower half of the sac. Many authors claim that the axilla of the middle turbinate is a landmark for the roof of the lacrimal sac. However, Wormald and co-authors, in a study with 47 CT-DCG patients, showed that the major part of the lacrimal sac (10 mm) is situated above the axilla of the middle turbinate, extending 1-2 mm below this landmark.
Obtaining a large marsupialized lacrimal sac with wide removal of the covering bone, medial wall of the sac and use of mucosal flaps yields a good surgical result that is comparable to the results of conventional endoscopic DCR techniques with two advantages first, primary surgical failures are amenable to technically simple and highly successful surgical revisions, second, there is a possibility for obtaining wide fenstrum without silicone tube stenting.
Success after lacrimal surgery is ill defined, and this has led to confusion in the interpretation of results for various surgical methods. The most practical measure of success is the control of symptoms, although this can be at odds with anatomic outcome.
Subjective success in turn can be assessed from the patients' symptoms. Complete relief or significant improvement of complaints can be considered a subjective success.
Anatomical patency can readily be judged in objective tests: functional endoscopic dye test or inspection of the ostium, irrigation or fluorescein retention test. Functional NLDO was first described by Demorest and Miller in 1955 to encompass lacrimal drainage dysfunction in the presence of anatomical patency. In those cases, there is a need to exclude other conditions causing epiphora, such as hyper-secretion, lacrimal pump failure, discontinuous drainage apparatus and partial lacrimal duct obstruction. The anatomical success rate i.e. the patency is reported to be higher than the functional success, which highlights the importance of measuring the physiological success and there relief of the patient's symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wide fenstrum Endoscopic DCR | Active comparator | Procedure: Endoscopic dacryocystorhinostomy |
| Narrow Fenstrum Endoscopic DCR | Active comparator | Procedure: Endoscopic dacryocystorhinostomy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients presented with epiphora due to nasolacrimal duct obstruction with patent canaliculi.
- failed conservative treatment in the form of systemic antibiotics, steroid/antibiotic eye drops, decongestant nasal drops and local nasal steroid spray.
- fit for surgery under general anesthesia.
Key exclusion criteria (5 listed)
- 1- Epiphora due to pre-saccal obstruction of lacrimal drainage system.
- 2. Eye disease causing increased lacrimation and eyelid malposition
- 3. Lacrimal fistula.
- 4. Tumors of the lacrimal passage, nose or paranasal sinus.
- 5. Patients with abnormal bleeding or coagulation time.
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 |
|---|---|---|
| Endoscopic dacryocystorhinostomyEndoscopic DCR | Procedure or surgery | Narrow Fenstrum Endoscopic DCR, Wide fenstrum Endoscopic DCR |
Primary outcome
Endoscopic assessment
Time frame: 1 year postoperative
Measurement dimensions of the DCR ostium by measuring length and width in mile meters by using nasal endoscope
Objective assessment
Time frame: 1 year postoperative
Objective assessment by flourscine disappearance test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Background: PubMed 33388192Bertaux PJ, Gan G, Hirtz G, Mouret P, El-Hachem F, Lhuillier L, Perone JM. Evaluation of ostium size following endoscopic dacryocystorhinostomy as a predictive factor of outcome: A prospective study. J Fr Ophtalmol. 2021 Mar;44(3):397-403. doi: 10.1016/j.jfo.2020.05.024. Epub 2020 Dec 30.
- Background: PubMed 25525327Ali MJ, Psaltis AJ, Wormald PJ. Dacryocystorhinostomy ostium: parameters to evaluate and DCR ostium scoring. Clin Ophthalmol. 2014 Dec 9;8:2491-9. doi: 10.2147/OPTH.S73998. eCollection 2014.
- Background: PubMed 16826055Mann BS, Wormald PJ. Endoscopic assessment of the dacryocystorhinostomy ostium after endoscopic surgery. Laryngoscope. 2006 Jul;116(7):1172-4. doi: 10.1097/01.mlg.0000218099.33523.19.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic dacryocystorhinostomy in people with Epiphora and Dacryocystitis, run by Menoufia 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 3 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 6 Apr 2021. 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.
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?
Endoscopic assessment (time frame: 1 year postoperative). 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?
On the ClinicalTrials.gov record for NCT04833452, which also lists 3 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 6 Apr 2021; AzTrials last refreshed its copy on 28 Oct 2026.