Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-18 @ 11:07 PM
Study NCT ID:
NCT02503956
Status:
COMPLETED
Last Update Posted:
2017-10-02
First Post:
2015-06-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perforated Punctal Plugs for Treatment of Papillary Conjunctivitis in Otherwise Healthy Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D003231', 'term': 'Conjunctivitis'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-07-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-28', 'studyFirstSubmitDate': '2015-06-24', 'studyFirstSubmitQcDate': '2015-07-20', 'lastUpdatePostDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Epiphoric state', 'timeFrame': '3 Months', '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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Epiphora', 'Conjunctivitis']}, 'referencesModule': {'references': [{'pmid': '24892278', 'type': 'RESULT', '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.'}, {'pmid': '22848141', 'type': 'RESULT', '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.'}, {'pmid': '18806663', 'type': 'RESULT', '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.'}, {'pmid': '21386741', 'type': 'RESULT', '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.'}, {'pmid': '22241928', 'type': 'RESULT', '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.'}, {'pmid': '24036740', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "The efficacy of punctal dilatation with insertion of perforated punctal plugs for the management of acquired punctal stenosis due to allergic conjunctivitis.\n\nAcquired 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.\n\nThe 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.\n\nRecently 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.\n\nThere 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.\n\nThe 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.\n\nUnfortunately, 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.\n\nAnother 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.\n\nAlthough 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.\n\nStudy 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.\n\nAdult, 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.\n\nPlug 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.\n\nRecords 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Patients suffering from acquired punctual stenosis due to chronic allergic conjunctivitis.\n* 18 - 100 Years old\n* Able to sign an informed consent and agree to participate Exclusion Criteria\n* Previous manipulation of lacrimal ducts of punctum\n* Patients unable to follow study protocol'}, 'identificationModule': {'nctId': 'NCT02503956', 'briefTitle': 'Perforated Punctal Plugs for Treatment of Papillary Conjunctivitis in Otherwise Healthy Patients', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'The Efficacy of Punctal Dilatation With Insertion of Perforated Punctal Plugs for the Management of Acquired Punctal Stenosis Due to Allergic Conjunctivitis', 'orgStudyIdInfo': {'id': '0557-14-RMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treated group', 'description': 'Patients treated with perforated punctal plugs', 'interventionNames': ['Device: Perforated Punctal plugs']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparison group', 'description': 'Comparison group treated with standard of care - Lacrimal intubation with Crawford lacrimal tube', 'interventionNames': ['Procedure: Crawford tube insertion', 'Device: Crawford lacrimal tube']}], 'interventions': [{'name': 'Perforated Punctal plugs', 'type': 'DEVICE', 'description': 'Perforated punctal plugs', 'armGroupLabels': ['Treated group']}, {'name': 'Crawford tube insertion', 'type': 'PROCEDURE', 'armGroupLabels': ['Comparison group']}, {'name': 'Crawford lacrimal tube', 'type': 'DEVICE', 'armGroupLabels': ['Comparison group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5590000', 'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Rabin Medical Center', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'overallOfficials': [{'name': 'Itay Gabbay, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Physician'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alpha Net Co. Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}