Lacrimal Duct ObstructionPhase 1/2ACSOTEOFLDONCT02636257
A Comparative Study of Two Endoscopic Operations for Lacrimal Duct Obstruction
A Phase 1/2 study testing Recessive Spherical Headed Silicone Intubation and Dacryocystorhinostomy in people with Lacrimal Duct Obstruction, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
To compare the clinical effects between the silicone nasolacrimal intubation under nasoendoscopy and dacryocystorhinostomy on patients with lacrimal duct obstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lacrimal Duct Obstruction
- What is being tested?
- Recessive Spherical Headed Silicone Intubation and Dacryocystorhinostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to Jan 2017
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Nasolacrimal Duct Obstruction based on a clinical of epiphora and purulent secretion, another punctiform orifices with reflux in subsequent flushing in lacrimal passage irrigation;
- Must be able to withstand surgery
- At least 18 years old
- NO lacrimal tumor and acute inflammation
- Nasolacrimal duct obstruction in digital subtraction dacryocystography
- A sufficient level of education to understand study procedures and be able to communicate with site personnel and adhere to the follow-up;
- Accepted informed consent verbally and in writing
Who cannot join
- The Poor Health
- Be allergic to anesthetics
- Lacrimal duct abnormalities
- Lacrimal tumor and acute inflammation
- Children
- The same Surgery failure before
Show all 9Show fewer
- Exit Criteria
- Postoperative infection and persistent inflammation
- Operation failure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study of Recessive Spherical Headed Silicone Intubation and Dacryocystorhinostomy Under Nasal Endoscopy in the Treatment of Nasolacrimal Duct Obstruction
To compare the clinical effects between the silicone nasolacrimal intubation under nasoendoscopy and dacryocystorhinostomy on patients with lacrimal duct obstruction.
Read the detailed description
Lacrimal duct obstruction is common among patients with epiphora,which is seriously affect the quality of life. The treatment principle is to restore or rebuild the lacrimal duct drainage channel. The classic operation type is dacryocystorhinostomy(DCR), which is complex for face-section particularly. However, with the development of endoscopy, the investigators prefer to the silicone nasolacrimal intubation under nasal endoscopy, which is more simple and efficient. With endoscopy, the investigators can see anatomical structures clearly and then can perform the operation much more perfectly.Compare to the classic one called DCR, its short and long term therapeutic effects are equal and even better.Therefore,the latter type does do good to both doctors and patients.
- Conditions
- Lacrimal Duct Obstruction
- Being tested
- Recessive Spherical Headed Silicone Intubation, Dacryocystorhinostomy
- Keywords
- Silicone Nasolacrimal Intubation, Dacryocystorhinostomy
- Medical subject headings
- Lacrimal Duct Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recessive Spherical Headed Silicone IntubationProcedure or surgery
Local anesthesia,regular disinfection, spread sterile towels, exposure operative side.2%lidocaine infiltration anesthesia to inferior orbital nerves, lacrimal punctum and lacrimal sac. Nasal cavity was packed with gauze soaked in 2%ephedrine with 1%tetracaine 15 minutes before procedure.A routine silicone tube of spherical intubation was performed. Dilatated lacrimal point to the end, then inserted the probe with line from lacrimal punctum to inferior meatus through nasolacrimal duct.Cut the line and flush the lacrimal duct physiological saline in 5 mL, flowing the line into the inferior meatus, then suctioned out the line with nasal endoscopy and extracted the probe and dilatated the lacrimal duct again. Insert the spherical silicone tube from lacrimal point to the lacrimal sac, reversing to vertical direction to ensure the tube is inserted into the nasolacrimal duct, then catch the above line but cut short the follow one and fix.Unobstructed lacrimal irrigation.
DacryocystorhinostomyProcedure or surgery
Surgery was performed under local anesthesia.Incision was taken over anterior lacrimal crest.Medial palpebral ligament was identified.Orbicularis was separated.Reflection of periosteum and dissection of lacrimal sac from lacrimal fossa was done.Sac was excised to make'H'shaped anterior and posterior flaps. Bony osteum of sufficient size was made with bone punch.Nasal mucosa was cut to make anterior and posterior flaps.Subsequently anterior to anterior and posterior to posterior flaps were sutured.
| Study group | Role | What they receive |
|---|---|---|
| Recessive Spherical Headed Silicone Intubation | Experimental | The silicone nasolacrimal intubation under nasal endoscopy can restore natural drainage pathway in tears and as an out-patient surgery, it is more simple,cheap and mini-invasive.Recessive Spherical Headed Silicone Intubation is safe,convenient and almost unpainful for no trauma.It has no facial scar and no damage for structure and function of lacrimal duct.Besides,silica gel is non-toxic and nonirritating.Nasal endoscopy handed by otorhinolaryngologist helps intraoperative visualization about anatomy of the nasal cavity,understanding and management of congenital nasolacrimal duct obstruction and is the only method that confirms the correct anatomic position of the catheterization and in real time,avoiding traditionally the blind raking-out wire by the ophthalmologist alone.Compare to the classic DCR,its short therapeutic effects are equal but more convenient and fewer time and money-cost. Receives: Procedure: Recessive Spherical Headed Silicone Intubation |
| Dacryocystorhinostomy | Other | Nasolacrimal duct obstruction is common among patients with epiphora,which is seriously affect the quality of life. The treatment principle is to restore or rebuild the lacrimal duct drainage channel. The classic operation type is dacryocystorhinostomy(DCR), which is complex for face-section particularly.After surgery the lacrimal passage can't siphon the tear out physically any more so that it will effect the patients' life.Besides,the operating time,bleeding volume,hospitalization time and total cost for the surgery is higher. Receives: Procedure: Dacryocystorhinostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epiphora Improvement
Cure:postoperative epiphora disappeared. Effective:clinical symptom remission. Invalid:no effect on epiphora.
Measured: one-year follow-up
Lacrimal Passage Irrigation
Cure:no reflux after lacrimal passage irrigation. Effective:a little reflux after lacrimal passage irrigation. Invalid:a lot reflux after lacrimal passage irrigation.
Measured: one-year follow-up
Secondary outcomes (1)
Postoperative Visual Analogue Scale (VAS)
From 0 to 10 according to the patients' feeling and life quality
Measured: Six times in one-year follow-up,respectively,immediate post-surgical,the 1th week,the 1th month,the 3rd month,the 6th month and the 12th month after the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startJul 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lacrimal 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deng Huiyi, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Yang Qintai, director, Study director, Sun Yat Sen Univ, Affiliated Hosp 3, Dept Otorhinolaryngol Head & Neck Surg, Guangzhou 510630, Guangdong, Peoples R China.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636257
- Sponsor's protocol ID
- SYSU-5010
- Acronym
- ACSOTEOFLDO
- Status last verified
- Oct 2017
- First submitted
- 9 Dec 2015
- Last updated
- 11 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
McDonogh M, Meiring JH. Endoscopic transnasal dacryocystorhinostomy. J Laryngol Otol. 1989 Jun;103(6):585-7. doi: 10.1017/s0022215100109405.
PubMed 2769026Onerci M, Orhan M, Ogretmenoglu O, Irkec M. Long-term results and reasons for failure of intranasal endoscopic dacryocystorhinostomy. Acta Otolaryngol. 2000 Mar;120(2):319-22. doi: 10.1080/000164800750001170.
PubMed 11603798Wormald PJ. Powered endoscopic dacryocystorhinostomy. Laryngoscope. 2002 Jan;112(1):69-72. doi: 10.1097/00005537-200201000-00013.
PubMed 11802041Saroj G, Rashmi G. Conventional dacryocystorhinostomy versus endonasal dacryocystorhinostomy-a comparative study. Indian J Otolaryngol Head Neck Surg. 2010 Sep;62(3):296-8. doi: 10.1007/s12070-010-0087-4. Epub 2010 Oct 12.
PubMed 23120728
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Recessive Spherical Headed Silicone Intubation and Dacryocystorhinostomy Under Nasal Endoscopy in the Treatment of Nasolacrimal Duct Obstruction
- ClinicalTrials.gov ID
- NCT02636257
- Acronym / sponsor ID
- ACSOTEOFLDO / SYSU-5010
- Conditions
- Lacrimal Duct Obstruction
- Keywords
- Silicone Nasolacrimal Intubation, Dacryocystorhinostomy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 21 Dec 2015 (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.
To compare the clinical effects between the silicone nasolacrimal intubation under nasoendoscopy and dacryocystorhinostomy on patients with lacrimal duct obstruction.
Detailed description
Lacrimal duct obstruction is common among patients with epiphora,which is seriously affect the quality of life. The treatment principle is to restore or rebuild the lacrimal duct drainage channel. The classic operation type is dacryocystorhinostomy(DCR), which is complex for face-section particularly. However, with the development of endoscopy, the investigators prefer to the silicone nasolacrimal intubation under nasal endoscopy, which is more simple and efficient. With endoscopy, the investigators can see anatomical structures clearly and then can perform the operation much more perfectly.Compare to the classic one called DCR, its short and long term therapeutic effects are equal and even better.Therefore,the latter type does do good to both doctors and patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recessive Spherical Headed Silicone Intubation | Experimental | Procedure: Recessive Spherical Headed Silicone IntubationThe silicone nasolacrimal intubation under nasal endoscopy can restore natural drainage pathway in tears and as an out-patient surgery, it is more simple,cheap and mini-invasive.Recessive Spherical Headed Silicone Intubation is safe,convenient and almost unpainful for no trauma.It has no facial scar and no damage for structure and function of lacrimal duct.Besides,silica gel is non-toxic and nonirritating.Nasal endoscopy handed by otorhinolaryngologist helps intraoperative visualization about anatomy of the nasal cavity,understanding and management of congenital nasolacrimal duct obstruction and is the only method that confirms the correct anatomic position of the catheterization and in real time,avoiding traditionally the blind raking-out wire by the ophthalmologist alone.Compare to the classic DCR,its short therapeutic effects are equal but more convenient and fewer time and money-cost. |
| Dacryocystorhinostomy | Other | Procedure: DacryocystorhinostomyNasolacrimal duct obstruction is common among patients with epiphora,which is seriously affect the quality of life. The treatment principle is to restore or rebuild the lacrimal duct drainage channel. The classic operation type is dacryocystorhinostomy(DCR), which is complex for face-section particularly.After surgery the lacrimal passage can't siphon the tear out physically any more so that it will effect the patients' life.Besides,the operating time,bleeding volume,hospitalization time and total cost for the surgery is higher. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical diagnosis of Nasolacrimal Duct Obstruction based on a clinical of epiphora and purulent secretion, another punctiform orifices with reflux in subsequent flushing in lacrimal passage irrigation;
- Must be able to withstand surgery
- At least 18 years old
- NO lacrimal tumor and acute inflammation
- Nasolacrimal duct obstruction in digital subtraction dacryocystography
Key exclusion criteria (9 listed)
- The Poor Health
- Be allergic to anesthetics
- Lacrimal duct abnormalities
- Lacrimal tumor and acute inflammation
- Children
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 |
|---|---|---|
| Recessive Spherical Headed Silicone IntubationLocal anesthesia,regular disinfection, spread sterile towels, exposure operative side.2%lidocaine infiltration anesthesia to inferior orbital nerves, lacrimal punctum and lacrimal sac. Nasal cavity was packed with gauze soaked in 2%ephedrine with 1%tetracaine 15 minutes before procedure.A routine silicone tube of spherical intubation was performed. Dilatated lacrimal point to the end, then inserted the probe with line from lacrimal punctum to inferior meatus through nasolacrimal duct.Cut the line and flush the lacrimal duct physiological saline in 5 mL, flowing the line into the inferior meatus, then suctioned out the line with nasal endoscopy and extracted the probe and dilatated the lacrimal duct again. Insert the spherical silicone tube from lacrimal point to the lacrimal sac, reversing to vertical direction to ensure the tube is inserted into the nasolacrimal duct, then catch the above line but cut short the follow one and fix.Unobstructed lacrimal irrigation. | Procedure or surgery | Recessive Spherical Headed Silicone Intubation |
| DacryocystorhinostomySurgery was performed under local anesthesia.Incision was taken over anterior lacrimal crest.Medial palpebral ligament was identified.Orbicularis was separated.Reflection of periosteum and dissection of lacrimal sac from lacrimal fossa was done.Sac was excised to make'H'shaped anterior and posterior flaps. Bony osteum of sufficient size was made with bone punch.Nasal mucosa was cut to make anterior and posterior flaps.Subsequently anterior to anterior and posterior to posterior flaps were sutured. | Procedure or surgery | Dacryocystorhinostomy |
Primary outcome
Epiphora Improvement
Time frame: one-year follow-up
Cure:postoperative epiphora disappeared. Effective:clinical symptom remission. Invalid:no effect on epiphora.
Lacrimal Passage Irrigation
Time frame: one-year follow-up
Cure:no reflux after lacrimal passage irrigation. Effective:a little reflux after lacrimal passage irrigation. Invalid:a lot reflux after lacrimal passage irrigation.
1 secondary outcome
Postoperative Visual Analogue Scale (VAS)
Time frame: Six times in one-year follow-up,respectively,immediate post-surgical,the 1th week,the 1th month,the 3rd month,the 6th month and the 12th month after the surgery.
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 11 Oct 2017.
- Background: PubMed 2769026McDonogh M, Meiring JH. Endoscopic transnasal dacryocystorhinostomy. J Laryngol Otol. 1989 Jun;103(6):585-7. doi: 10.1017/s0022215100109405.
- Background: PubMed 11603798Onerci M, Orhan M, Ogretmenoglu O, Irkec M. Long-term results and reasons for failure of intranasal endoscopic dacryocystorhinostomy. Acta Otolaryngol. 2000 Mar;120(2):319-22. doi: 10.1080/000164800750001170.
- Background: PubMed 11802041Wormald PJ. Powered endoscopic dacryocystorhinostomy. Laryngoscope. 2002 Jan;112(1):69-72. doi: 10.1097/00005537-200201000-00013.
- Background: PubMed 23120728Saroj G, Rashmi G. Conventional dacryocystorhinostomy versus endonasal dacryocystorhinostomy-a comparative study. Indian J Otolaryngol Head Neck Surg. 2010 Sep;62(3):296-8. doi: 10.1007/s12070-010-0087-4. Epub 2010 Oct 12.
- Individual participant dataSharing planned: Undecided
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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.
Yang Qintai, director study director
Sun Yat Sen Univ, Affiliated Hosp 3, Dept Otorhinolaryngol Head & Neck Surg, Guangzhou 510630, Guangdong, Peoples R China.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Recessive Spherical Headed Silicone Intubation and Dacryocystorhinostomy in people with Lacrimal Duct Obstruction, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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 7 inclusion and 9 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 11 Oct 2017. 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 China. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Epiphora Improvement (time frame: one-year follow-up). 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 NCT02636257, which also lists 4 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 11 Oct 2017.