Long-term (12-month) improvement in meibomian gland function and reduced dry eye symptoms with a single thermal pulsation treatment

Clin Exp Ophthalmol. 2013 Aug;41(6):524-30. doi: 10.1111/ceo.12033. Epub 2012 Dec 14.

Abstract

Purpose: To determine the 1-year post-treatment dry eye status of subjects with meibomian gland dysfunction and dry eye symptoms after receiving a single LipiFlow Thermal Pulsation System treatment.

Design: Single-centre, prospective, observational, open-label, 1-month-registered clinical trial with a 1-year follow-up examination.

Participants: Patients with evaporative dry eye disease with meibomian gland dysfunction and dry eye symptoms who had participated in the registered 1-month clinical trial.

Methods: Eighteen of 30 subjects initially enrolled were able to return for a 1-year follow-up. Both eyes of all patients were treated with a single 12-min treatment using the LipiFlow Thermal Pulsation System. Meibomian gland function, tear break-up time and dry eye symptoms were measured. Data are presented for pretreatment (baseline), and 1-month and 1-year post-treatment.

Main outcome measures: Meibomian gland secretion scores, and tear break-up time and dry eye symptoms.

Results: Significant improvement in meibomian gland secretion scores from baseline measurements (4.0 ± 3.4) to 1-month post-treatment (11.3 ± 4.7; P < 0.0005) was maintained at 1-year (7.3 ± 4.6; P < 0.05). Baseline tear break-up time (4.9 ± 3.0) was significantly increased at 1-month (9.5 ± 6.9; P < 0.05); however, this improvement was no longer evident at 1-year post-treatment (6.0 ± 4.4). The significant improvement in symptom scores on Ocular Surface Disease Index and Standard Patient Evaluation of Eye Dryness questionnaires observed at 1-month (P < 0.0005) was maintained at 1-year (Ocular Surface Disease Index [P < 0.05]; Standard Patient Evaluation of Eye Dryness [P < 0.0005]).

Conclusion: A single 12-min treatment with the Lipi Flow Thermal Pulsation System offers an effective treatment for evaporative dry eye and meibomian gland dysfunction resulting in significant and sustained improvement in signs and symptoms for up to 1 year.

Keywords: LipiFlow thermal pulsation system; dry eye; meibomian gland dysfunction.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Dry Eye Syndromes / physiopathology
  • Dry Eye Syndromes / therapy*
  • Eyelid Diseases / physiopathology
  • Eyelid Diseases / therapy*
  • Female
  • Humans
  • Hyperthermia, Induced / methods*
  • Male
  • Meibomian Glands / physiology*
  • Middle Aged
  • Prospective Studies
  • Surveys and Questionnaires
  • Tears / chemistry
  • Treatment Outcome