EpiphoraPhase 4NCT01010659
The Safety and Efficacy of Lacrimal Silicone Intubation for the Management of Epiphora
A Phase 4 study testing Lacrimal Tube in people with Epiphora, run by Aurolab at 1 site in India.
Trial summary
The purpose of study is to investigate the safety and efficacy of lacrimal silicone intubation for the management of epiphora. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Epiphora
- What is being tested?
- Lacrimal Tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2009to Jun 2011
- Phase
- Phase 4
- 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 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects having epiphora
- Canalicular blockade ascertained with probing
- Chronic dacryocystitis
- Mucocele
Who cannot join
- Absent puncta
- Acute on chronic dacryocystitis
- Noticeable lid laxity
- Previous lacrimal surgery
- Patients younger than 15 years
- Suspicion of malignancy
- Post traumatic lids
- Bony deformity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Clinical Evaluation of Dacryocystorhinostomy (DCR) With Lacrimal Intubation
The purpose of study is to investigate the safety and efficacy of lacrimal silicone intubation for the management of epiphora.
Read the detailed description
Epiphora is an overflow of tears,usually caused by insufficient drainage of the tear film from the eye.The most common cause is a blockage of the lacrimal ducts located next to the nose, but the condition may also result from the excessive production of tears. Epiphora is a symptom rather than a disease and may be caused by a variety of conditions.
30 subjects will be recruited for this study, informed consent will be taken from the willing subjects. Complete ophthalmic evaluation would be performed including visual acuity. Diagnosis would be made on history of epiphora, regurgitation test, lids examination, nasal examination, probing and syringing. Standard procedure of Dacryocystorhinostomy (DCR) would be adopted in all cases with lacrimal intubation.
Syringing will be done on first follow up visit and skin sutures will also be removed. Tightness and mobility of the silicone tube will be checked. The tube is kept in place for 3-6 months according to need and then finally removed. The patency of lacrimal passage will be investigated by irrigation. A successful outcome will be defined as resolution of symptoms like epiphora and discharge and a patent lacrimal system on irrigation.
- Conditions
- Epiphora
- Being tested
- Lacrimal Tube
- Keywords
- Dacryocystorhinostomy
- Medical subject headings
- Lacrimal Apparatus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lacrimal TubeDevice
Also called Auro-lac
Lacrimal Tube
| Study group | Role | What they receive |
|---|---|---|
| Lacrimal Tube | Experimental | Dacryocystorhinostomy with silicone lacrimal intubation Receives: Device: Lacrimal Tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of epiphora
Measured: 15th Day, 1st Month, 6th Month and 12th month
Secondary outcomes (1)
Post operative complications
Measured: 15th Day, 1st Month, 6th Month and 12th Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionMar 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aurolab
- Sponsor type
- University, hospital or other
- Investigators
- Dr. Usha Kim, MBBS, DO, Principal investigator, Aravind Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01010659
- Sponsor's protocol ID
- 1PN1010940
- Status last verified
- Jul 2011
- First submitted
- 5 Nov 2009
- Last updated
- 15 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Evaluation of Dacryocystorhinostomy (DCR) With Lacrimal Intubation
- ClinicalTrials.gov ID
- NCT01010659
- Acronym / sponsor ID
- 1PN1010940
- Conditions
- Epiphora
- Keywords
- Dacryocystorhinostomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AurolabUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 10 Nov 2009 (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.
The purpose of study is to investigate the safety and efficacy of lacrimal silicone intubation for the management of epiphora.
Detailed description
Epiphora is an overflow of tears,usually caused by insufficient drainage of the tear film from the eye.The most common cause is a blockage of the lacrimal ducts located next to the nose, but the condition may also result from the excessive production of tears. Epiphora is a symptom rather than a disease and may be caused by a variety of conditions.
30 subjects will be recruited for this study, informed consent will be taken from the willing subjects. Complete ophthalmic evaluation would be performed including visual acuity. Diagnosis would be made on history of epiphora, regurgitation test, lids examination, nasal examination, probing and syringing. Standard procedure of Dacryocystorhinostomy (DCR) would be adopted in all cases with lacrimal intubation.
Syringing will be done on first follow up visit and skin sutures will also be removed. Tightness and mobility of the silicone tube will be checked. The tube is kept in place for 3-6 months according to need and then finally removed. The patency of lacrimal passage will be investigated by irrigation. A successful outcome will be defined as resolution of symptoms like epiphora and discharge and a patent lacrimal system on irrigation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lacrimal Tube | Experimental | Device: Lacrimal TubeDacryocystorhinostomy with silicone lacrimal intubation |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Subjects having epiphora
- Canalicular blockade ascertained with probing
- Chronic dacryocystitis
- Mucocele
Key exclusion criteria (8 listed)
- Absent puncta
- Acute on chronic dacryocystitis
- Noticeable lid laxity
- Previous lacrimal surgery
- Patients younger than 15 years
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 |
|---|---|---|
| Lacrimal TubeAlso: Auro-lacLacrimal Tube | Device | Lacrimal Tube |
Primary outcome
Resolution of epiphora
Time frame: 15th Day, 1st Month, 6th Month and 12th month
1 secondary outcome
Post operative complications
Time frame: 15th Day, 1st Month, 6th Month and 12th Month
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 15 Jul 2011.
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A Comparative Analysis of the Effectiveness of Nepafenac Combined With a Lubricant Versus a Lubricant Alone in the Treatment of Epiphora Associated With Lacrimal Punctum Stenosis
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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.
Dr. Usha Kim, MBBS, DO principal investigator
Aravind Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lacrimal Tube in people with Epiphora, run by Aurolab at 1 site in India.
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 4 inclusion and 8 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 15 Jul 2011. 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 India. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Resolution of epiphora (time frame: 15th Day, 1st Month, 6th Month and 12th month). 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 15 Jul 2011.