Punctal Plug Retention Rates for the Treatment of Moderate to Severe Dry Eye: A Randomized, Double-Masked, Controlled Clinical Trial.

PURPOSE: To compare retention rates of Super Flex (Eagle Vision, Memphis, Tennessee, USA; Softplug-Oasis Medical Inc, Glendora, California, USA) vs Parasol (Odyssey Medical, Memphis, Tennessee, USA; Beaver Visitec International, Waltham, Massachusetts, USA) punctal plugs.

DESIGN

Randomized, double-masked, interventional controlled clinical trial.

METHODS

Institutional study at Hotel Dieu Hospital (Queen's University) of 50 eyes, from patients with moderate to severe dry eye. Each eye from eligible patients was separately randomized to receive Super Flex or Parasol punctal plugs. The main outcome measure was plug retention at 6 months. Secondary outcome measures included objective tests of Schirmer I (mm), tear meniscus height (mm), tear break-up time (s), inferior fluorescein corneal staining (National Eye Institute [NEI] scale), and average lissamine green conjunctival staining (NEI scale).

RESULTS

Punctal plug retention was significantly different at 6 months (P = .011). Sixty-eight percent of Parasol plugs were retained compared to 32% of Super Flex plugs. Parasol plugs required less frequent artificial tear use at 6 months (P = .024). There was a statistically significant improvement in all secondary outcome measures (Schirmer, tear meniscus height, tear break-up time, fluorescein corneal staining) at 6 months within plug groups except conjunctival staining. There were no additional significant differences between groups and no plug complications reported.

CONCLUSIONS

Punctal plugs improve symptoms of moderate to severe dry eye; however, retention rates differ significantly. These data will allow us to guide patient decision making for the safe and effective treatment of punctal plugs for moderate to severe dry eye.