Perforated Punctal Plugs for Treatment of Papillary Conjunctivitis in Otherwise Healthy Patients
Condition: Epiphora; Conjunctivitis
MeSH terms: Conjunctivitis; Lacrimal Apparatus Diseases
Study type: Interventional

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.
    

Intervention name(s): Perforated Punctal plugs; Crawford tube insertion; Crawford lacrimal tube
Intervention type(s): Device; Procedure; Device
Intervention description(s): Perforated punctal plugs
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment