Perforated Punctal Plug as an alternative to the three snip punctoplasty for the treatment of acquired lacrimal punctum stenosis: POPPY Study
Imperial College London and Imperial College Healthcare NHS Trust
Duration of Study in the UK
3 years, 0 months, 0 days
Punctal stenosis is a condition where the very top part of tear drainage system is narrow. Normally tears drain from the eyes, down the nasolacrimal duct into the nose, from where they drain into the throat. The punctum is the opening of this drainage system on the eyelid. Narrowing of this opening (punctal stenosis) is a common cause of a watery eye. As well as being a nuisance, watering can result in blurred vision.
Acquired punctal stenosis (APS) may result from ageing, eyelid malposition, infection, trauma, thermal injury, systemic or topical chemotherapy and inflammatory eyelid conditions.
Several treatment options exist, including 3-snip punctoplasty and perforated punctal plugs (PPPs). Traditionally 3-snip punctoplasty has been the standard treatment and remains so in many departments. PPPs have been available since the late 1980s and have become more popular over the last decade as a first line treatment for punctal stenosis. Despite some evidence as to the efficacy of both PPPs and the 3-snip procedure, there is no published evidence of a direct comparison between them.
If the PPPs have an equivalent success rate to the 3-snip, they have the advantages of being reversible, not permanently disrupting the anatomy, and not precluding later punctoplasty if required. The plugs are easily inserted in an outpatient clinic setting and cost approximately £54 per plug so are cheaper to the NHS than a 3 snip.
Our study is a randomised comparative study comparing PPP to 3-snip punctoplasty.
We will assess the long term (one year) effect size of the two treatments.
This study will use a newly designed questionnaire to assess the impact that the intervention has on the patients’ quality of life (QOL) and will assess the value of OCT scanning as an objective outcome measure for this condition.
London - Central Research Ethics Committee
Date of REC Opinion
5 Jul 2017