Perforated Punctal Plugs for Treatment of Papillary Conjunctivitis in Otherwise Healthy Patients
Primary Purpose
Epiphora, Conjunctivitis
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Perforated Punctal plugs
Crawford tube insertion
Crawford lacrimal tube
Sponsored by
About this trial
This is an interventional treatment trial for Epiphora
Eligibility Criteria
Inclusion Criteria
- 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
Sites / Locations
- Rabin Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treated group
Comparison group
Arm Description
Patients treated with perforated punctal plugs
Comparison group treated with standard of care - Lacrimal intubation with Crawford lacrimal tube
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02503956
First Posted
June 24, 2015
Last Updated
September 28, 2017
Sponsor
Rabin Medical Center
Collaborators
Alpha Net Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02503956
Brief Title
Perforated Punctal Plugs for Treatment of Papillary Conjunctivitis in Otherwise Healthy Patients
Official Title
The Efficacy of Punctal Dilatation With Insertion of Perforated Punctal Plugs for the Management of Acquired Punctal Stenosis Due to Allergic Conjunctivitis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
July 22, 2016 (Actual)
Study Completion Date
July 22, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rabin Medical Center
Collaborators
Alpha Net Co. Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epiphora, Conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treated group
Arm Type
Experimental
Arm Description
Patients treated with perforated punctal plugs
Arm Title
Comparison group
Arm Type
Active Comparator
Arm Description
Comparison group treated with standard of care - Lacrimal intubation with Crawford lacrimal tube
Intervention Type
Device
Intervention Name(s)
Perforated Punctal plugs
Intervention Description
Perforated punctal plugs
Intervention Type
Procedure
Intervention Name(s)
Crawford tube insertion
Intervention Type
Device
Intervention Name(s)
Crawford lacrimal tube
Primary Outcome Measure Information:
Title
Epiphoric state
Description
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
Time Frame
3 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Itay Gabbay, MD
Organizational Affiliation
Physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rabin Medical Center
City
Petach Tikva
ZIP/Postal Code
5590000
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
24892278
Citation
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.
Results Reference
result
PubMed Identifier
22848141
Citation
Soiberman 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 Reference
result
PubMed Identifier
18806663
Citation
Konuk 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 Reference
result
PubMed Identifier
21386741
Citation
Mathew 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 Reference
result
PubMed Identifier
22241928
Citation
Hussain 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 Reference
result
PubMed Identifier
24036740
Citation
Chang 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.
Results Reference
result
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Perforated Punctal Plugs for Treatment of Papillary Conjunctivitis in Otherwise Healthy Patients
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