EpiphoraNCT02503956
Perforated Punctal Plugs for Treatment of Papillary Conjunctivitis in Otherwise Healthy Patients
A study testing Perforated Punctal plugs, Crawford tube insertion and Crawford lacrimal tube in people with Epiphora and Conjunctivitis, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Assessing efficacy of punctal dilatation with insertion of perforated punctal plugs for the management of acquired punctal stenosis due to allergic conjunctivitis in otherwise healthy patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Epiphora, Conjunctivitis
- What is being tested?
- Perforated Punctal plugs, Crawford tube insertion and Crawford lacrimal tube
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2015to 22 Jul 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering from acquired punctual stenosis due to chronic allergic conjunctivitis.
- 18 - 100 Years old
- Able to sign an informed consent and agree to participate Exclusion Criteria
- Previous manipulation of lacrimal ducts of punctum
- Patients unable to follow study protocol
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Punctal Dilatation With Insertion of Perforated Punctal Plugs for the Management of Acquired Punctal Stenosis Due to Allergic Conjunctivitis
Assessing efficacy of punctal dilatation with insertion of perforated punctal plugs for the management of acquired punctal stenosis due to allergic conjunctivitis in otherwise healthy patients.
Read the detailed description
The efficacy of punctal dilatation with insertion of perforated punctal plugs for the management of acquired punctal stenosis due to allergic conjunctivitis.
Acquired punctal stenosis is a condition in which the external opening of the lacrimal canaliculus is narrowed or occluded due to chronic inflammation and fibrosis. This condition is a rare cause of symptomatic epiphora, but its incidence may be higher in patients with chronic blepharitis, in those treated with various topical medications, including antihypertensive agents, and especially in patients treated with taxanes for cancer.
The incidence of punctal stenosis is still unknown, with reported rates ranging from 8% to 54.3%, depending on setting, demographics, and probably interob¬server variability. Nevertheless, the literature suggests that this pathology should be given special consideration while assessing the tearing patient, because it may involve an easier surgical solution than in patients with obstruction in the more distal lacrimal system.
Recently many oculoplastic surgeons encounter young patients (usually females) with punctual stenosis and signs of allergic conjunctivitis but no reflex tearing. In these cases, treatment for allergic conjunctivitis does not improve tearing. Treatment with punctoplasty of mini- Monoka stents improve their condition for the short term. However, many patients experience recurrence of epiphora in the long term.
There are no uniform clinical guidelines for treatment of the disease. A few methods are currently used in the management of punctal stenosis. The most common in use are punctoplasty or intubation with minimonoka stents. Substantial experience with these minor surgical snip procedures would suggest giving preference to their utilization in the treatment of the disease in our clinics.
The simplest method involves the use of perforated punctal plugs, a reversible simple procedure that can be applied in an office setting. Silicon perforated plugs are inserted after punctual dilatation under topical anesthesia to the lacrimal punctum in order to maintain a patent tear drain into the nasolacrimal sac. The procedure is simple and usually pain free. After the procedure topical steroids and antibiotics are prescribed for one week. Plugs are extracted after a two month period in the outpatient clinic.
Unfortunately, evidence for the efficacy of the procedure for acquired punctual stenosis is scarce. One retrospective series of 44 eyes from 26 patients treated with dilation and the placement of a perforated punctal plug for acquired punctal stenosis, the success rate was 84.1% (37 of 44 eyes) for cessation of epiphora. The plugs were extracted after 2 months. Most cases had partial punctal stenosis. Associated eyelid laxity was detected in 14 eyes, and eight of them underwent a lateral tarsal strip procedure prior to plug implantation. The mean follow-up period was 19 months. Failures were due to either restenosis or horizontal eyelid laxity.
Another study evaluated the use of perforated punctual plugs in patients with acquired punctual stenosis, 20 patients in total. This study showed 85% successes rate in total. Patients where the procedure failed were usually older and were likely to have blepharitis.
Although perforated punctal plugs are an attractive non¬surgical tool in the management of acquired punctal stenosis, the long-term results of the procedure and its role in treating punctal stenosis requires and prospective larger clinical trials.
Study design We intend to perform a prospective clinical trial to assess the efficacy of perforated punctual plugs in treating acquired punctual stenosis. Since patients were previously assigned to treatment by a Crawford tube insertion, this patient group will act as the comparison group for this study.
Adult, consenting patients will be recruited from the ophthalmology outpatient clinics in Rabin Medical Center. Punctal plugs will be inserted in the outpatient clinics for duration of two months.
Plug insertion will be performed under topical anesthesia after careful dilation of the lacrimal punctum. Patients will be prescribed topical steroids and antibiotic for a one week period following plug insertion procedure. Punctal plugs will be removed after two months treatment period. Follow up time is intended for two years to asses both short term and long term efficacy.
Records for patients who underwent Crawford tube insertion due to allergic conjunctivitis will be anonymously collected from Rabin Medical Centers' database. The collected data will be analyzed and used a comparison group for the study.
- Conditions
- Epiphora, Conjunctivitis
- Being tested
- Perforated Punctal plugs, Crawford tube insertion, Crawford lacrimal tube
- Medical subject headings
- Lacrimal Apparatus Diseases, Conjunctivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perforated Punctal plugsDevice
Perforated punctal plugs
Crawford tube insertionProcedure or surgery
Crawford lacrimal tubeDevice
| Study group | Role | What they receive |
|---|---|---|
| Treated group | Experimental | Patients treated with perforated punctal plugs Receives: Device: Perforated Punctal plugs |
| Comparison group | Active comparator | Comparison group treated with standard of care - Lacrimal intubation with Crawford lacrimal tube Receives: Procedure: Crawford tube insertion; Device: Crawford lacrimal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epiphoric state
Patient follow up after punctal plug removal, this is a dichotomic measure of yes/no question - weather of not the patient still suffers from tearing after treatment
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startAug 2015
- Primary completion22 Jul 2016
- Study completion22 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Alpha Net Co. Ltd.
- Responsible party
- Sponsor
- Investigators
- Itay Gabbay, MD, Principal investigator, Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503956
- Sponsor's protocol ID
- 0557-14-RMC
- Status last verified
- Feb 2017
- First submitted
- 24 Jun 2015
- Last updated
- 2 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Ali MJ, Mishra DK, Baig F, Lakshman M, Naik MN. Punctal stenosis: histopathology, immunology, and electron microscopic features-a step toward unraveling the mysterious etiopathogenesis. Ophthalmic Plast Reconstr Surg. 2015 Mar-Apr;31(2):98-102. doi: 10.1097/IOP.0000000000000204.
PubMed 24892278Soiberman U, Kakizaki H, Selva D, Leibovitch I. Punctal stenosis: definition, diagnosis, and treatment. Clin Ophthalmol. 2012;6:1011-8. doi: 10.2147/OPTH.S31904. Epub 2012 Jul 3.
PubMed 22848141Konuk O, Urgancioglu B, Unal M. Long-term success rate of perforated punctal plugs in the management of acquired punctal stenosis. Ophthalmic Plast Reconstr Surg. 2008 Sep-Oct;24(5):399-402. doi: 10.1097/IOP.0b013e318185a9ca.
PubMed 18806663Mathew RG, Olver JM. Mini-monoka made easy: a simple technique for mini-monoka insertion in acquired punctal stenosis. Ophthalmic Plast Reconstr Surg. 2011 Jul-Aug;27(4):293-4. doi: 10.1097/IOP.0b013e31820ccfaf.
PubMed 21386741Hussain RN, Kanani H, McMullan T. Use of mini-monoka stents for punctal/canalicular stenosis. Br J Ophthalmol. 2012 May;96(5):671-3. doi: 10.1136/bjophthalmol-2011-300670. Epub 2012 Jan 12.
PubMed 22241928Chang M, Ahn SE, Baek S. The effect of perforated punctal plugs in the management of acquired punctal stenosis. J Craniofac Surg. 2013 Sep;24(5):1628-30. doi: 10.1097/SCS.0b013e318292c68b.
PubMed 24036740
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Punctal Dilatation With Insertion of Perforated Punctal Plugs for the Management of Acquired Punctal Stenosis Due to Allergic Conjunctivitis
- ClinicalTrials.gov ID
- NCT02503956
- Acronym / sponsor ID
- 0557-14-RMC
- Conditions
- Epiphora, Conjunctivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- Alpha Net Co. Ltd.
- Study start
- Aug 2015
- Primary completion
- 22 Jul 2016 (actual)
- Study completion
- 22 Jul 2016 (actual)
- First posted
- 21 Jul 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.
Assessing efficacy of punctal dilatation with insertion of perforated punctal plugs for the management of acquired punctal stenosis due to allergic conjunctivitis in otherwise healthy patients.
Detailed description
The efficacy of punctal dilatation with insertion of perforated punctal plugs for the management of acquired punctal stenosis due to allergic conjunctivitis.
Acquired punctal stenosis is a condition in which the external opening of the lacrimal canaliculus is narrowed or occluded due to chronic inflammation and fibrosis. This condition is a rare cause of symptomatic epiphora, but its incidence may be higher in patients with chronic blepharitis, in those treated with various topical medications, including antihypertensive agents, and especially in patients treated with taxanes for cancer.
The incidence of punctal stenosis is still unknown, with reported rates ranging from 8% to 54.3%, depending on setting, demographics, and probably interob¬server variability. Nevertheless, the literature suggests that this pathology should be given special consideration while assessing the tearing patient, because it may involve an easier surgical solution than in patients with obstruction in the more distal lacrimal system.
Recently many oculoplastic surgeons encounter young patients (usually females) with punctual stenosis and signs of allergic conjunctivitis but no reflex tearing. In these cases, treatment for allergic conjunctivitis does not improve tearing. Treatment with punctoplasty of mini- Monoka stents improve their condition for the short term. However, many patients experience recurrence of epiphora in the long term.
There are no uniform clinical guidelines for treatment of the disease. A few methods are currently used in the management of punctal stenosis. The most common in use are punctoplasty or intubation with minimonoka stents. Substantial experience with these minor surgical snip procedures would suggest giving preference to their utilization in the treatment of the disease in our clinics.
The simplest method involves the use of perforated punctal plugs, a reversible simple procedure that can be applied in an office setting. Silicon perforated plugs are inserted after punctual dilatation under topical anesthesia to the lacrimal punctum in order to maintain a patent tear drain into the nasolacrimal sac. The procedure is simple and usually pain free. After the procedure topical steroids and antibiotics are prescribed for one week. Plugs are extracted after a two month period in the outpatient clinic.
Unfortunately, evidence for the efficacy of the procedure for acquired punctual stenosis is scarce. One retrospective series of 44 eyes from 26 patients treated with dilation and the placement of a perforated punctal plug for acquired punctal stenosis, the success rate was 84.1% (37 of 44 eyes) for cessation of epiphora. The plugs were extracted after 2 months. Most cases had partial punctal stenosis. Associated eyelid laxity was detected in 14 eyes, and eight of them underwent a lateral tarsal strip procedure prior to plug implantation. The mean follow-up period was 19 months. Failures were due to either restenosis or horizontal eyelid laxity.
Another study evaluated the use of perforated punctual plugs in patients with acquired punctual stenosis, 20 patients in total. This study showed 85% successes rate in total. Patients where the procedure failed were usually older and were likely to have blepharitis.
Although perforated punctal plugs are an attractive non¬surgical tool in the management of acquired punctal stenosis, the long-term results of the procedure and its role in treating punctal stenosis requires and prospective larger clinical trials.
Study design We intend to perform a prospective clinical trial to assess the efficacy of perforated punctual plugs in treating acquired punctual stenosis. Since patients were previously assigned to treatment by a Crawford tube insertion, this patient group will act as the comparison group for this study.
Adult, consenting patients will be recruited from the ophthalmology outpatient clinics in Rabin Medical Center. Punctal plugs will be inserted in the outpatient clinics for duration of two months.
Plug insertion will be performed under topical anesthesia after careful dilation of the lacrimal punctum. Patients will be prescribed topical steroids and antibiotic for a one week period following plug insertion procedure. Punctal plugs will be removed after two months treatment period. Follow up time is intended for two years to asses both short term and long term efficacy.
Records for patients who underwent Crawford tube insertion due to allergic conjunctivitis will be anonymously collected from Rabin Medical Centers' database. The collected data will be analyzed and used a comparison group for the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated group | Experimental | Device: Perforated Punctal plugsPatients treated with perforated punctal plugs |
| Comparison group | Active comparator | Procedure: Crawford tube insertion, Device: Crawford lacrimal tubeComparison group treated with standard of care - Lacrimal intubation with Crawford lacrimal tube |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients suffering from acquired punctual stenosis due to chronic allergic conjunctivitis.
- 18 - 100 Years old
- Able to sign an informed consent and agree to participate Exclusion Criteria
- Previous manipulation of lacrimal ducts of punctum
- Patients unable to follow study protocol
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Perforated Punctal plugsPerforated punctal plugs | Device | Treated group |
| Crawford tube insertion | Procedure or surgery | Comparison group |
| Crawford lacrimal tube | Device | Comparison group |
Primary outcome
Epiphoric state
Time frame: 3 Months
Patient follow up after punctal plug removal, this is a dichotomic measure of yes/no question - weather of not the patient still suffers from tearing after treatment
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 2 Oct 2017.
- Results publication: PubMed 24892278Ali MJ, Mishra DK, Baig F, Lakshman M, Naik MN. Punctal stenosis: histopathology, immunology, and electron microscopic features-a step toward unraveling the mysterious etiopathogenesis. Ophthalmic Plast Reconstr Surg. 2015 Mar-Apr;31(2):98-102. doi: 10.1097/IOP.0000000000000204.
- Results publication: PubMed 22848141Soiberman U, Kakizaki H, Selva D, Leibovitch I. Punctal stenosis: definition, diagnosis, and treatment. Clin Ophthalmol. 2012;6:1011-8. doi: 10.2147/OPTH.S31904. Epub 2012 Jul 3.
- Results publication: PubMed 18806663Konuk O, Urgancioglu B, Unal M. Long-term success rate of perforated punctal plugs in the management of acquired punctal stenosis. Ophthalmic Plast Reconstr Surg. 2008 Sep-Oct;24(5):399-402. doi: 10.1097/IOP.0b013e318185a9ca.
- Results publication: PubMed 21386741Mathew RG, Olver JM. Mini-monoka made easy: a simple technique for mini-monoka insertion in acquired punctal stenosis. Ophthalmic Plast Reconstr Surg. 2011 Jul-Aug;27(4):293-4. doi: 10.1097/IOP.0b013e31820ccfaf.
- Results publication: PubMed 22241928Hussain RN, Kanani H, McMullan T. Use of mini-monoka stents for punctal/canalicular stenosis. Br J Ophthalmol. 2012 May;96(5):671-3. doi: 10.1136/bjophthalmol-2011-300670. Epub 2012 Jan 12.
- Results publication: PubMed 24036740Chang M, Ahn SE, Baek S. The effect of perforated punctal plugs in the management of acquired punctal stenosis. J Craniofac Surg. 2013 Sep;24(5):1628-30. doi: 10.1097/SCS.0b013e318292c68b.
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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.
Itay Gabbay, MD principal investigator
Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perforated Punctal plugs, Crawford tube insertion and Crawford lacrimal tube in people with Epiphora and Conjunctivitis, run by Rabin Medical Center at 1 site in Israel.
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 5 inclusion and 0 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 2 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 Israel. 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?
Epiphoric state (time frame: 3 Months). 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 NCT02503956, which also lists 6 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 2 Oct 2017.