Perforated Punctal Plugs for Treatment of Papillary Conjunctivitis in Otherwise Healthy Patients

September 28, 2017 updated by: Rabin Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petach Tikva, Israel, 5590000
        • Rabin Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treated group
Patients treated with perforated punctal plugs
Device: Perforated Punctal plugs
Perforated punctal plugs
Active Comparator: Comparison group
Comparison group treated with standard of care - Lacrimal intubation with Crawford lacrimal tube
Procedure: Crawford tube insertion
Device: Crawford lacrimal tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Collaborators

Alpha Net Co. Ltd.

Investigators

  • Principal Investigator: Itay Gabbay, MD, Physician

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

July 22, 2016

Study Completion (Actual)

July 22, 2016

Study Registration Dates

First Submitted

June 24, 2015

First Submitted That Met QC Criteria

July 20, 2015

First Posted (Estimate)

July 21, 2015

Study Record Updates

Last Update Posted (Actual)

October 2, 2017

Last Update Submitted That Met QC Criteria

September 28, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0557-14-RMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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