The sustained effect (12 months) of a single-dose vectored thermal pulsation procedure for meibomian gland dysfunction and evaporative dry eye - PubMed (original) (raw)

The sustained effect (12 months) of a single-dose vectored thermal pulsation procedure for meibomian gland dysfunction and evaporative dry eye

Caroline A Blackie et al. Clin Ophthalmol. 2016.

Abstract

Purpose: To evaluate the sustained effect (up to 1 year) of a single, 12-minute vectored thermal pulsation (VTP) treatment in improving meibomian gland function and dry eye symptoms in patients with meibomian gland dysfunction and evaporative dry eye.

Methods: The prospective, multicenter, open-label clinical trial included 200 subjects (400 eyes) who were randomized to a single VTP treatment (treatment group) or twice-daily, 3-month, conventional warm compress and eyelid hygiene therapy (control group). Control group subjects received crossover VTP treatment at 3 months (crossover group). Effectiveness measures of meibomian gland secretion (MGS) and dry eye symptoms were evaluated at baseline and 1, 3, 6, 9, and 12 months. Subjects with inadequate symptom relief could receive additional meibomian gland dysfunction therapy after 3 (treatment group) and 6 months (crossover group).

Results: At 3 months, the treatment group had greater mean improvement in MGS (P<0.0001) and dry eye symptoms (P=0.0068), compared to controls. At 12 months, 86% of the treatment group had received only one VTP treatment, and sustained a mean improvement in MGS from 6.4±3.7 (baseline) to 17.3±9.1 (P<0.0001) and dry eye symptoms from 44.1±20.4 to 21.6±21.3 (P<0.0001); 89% of the crossover group had received only one VTP treatment with sustained mean improvement in MGS from 6.3±3.6 to 18.4±11.1 (P<0.0001) and dry eye symptoms from 49.1±21.0 to 24.0±23.2 (P<0.0001). Greater mean improvement in MGS was associated with less severe baseline MGS (P=0.0017) and shorter duration of time between diagnosis and treatment (P=0.0378).

Conclusion: A single VTP treatment can deliver a sustained mean improvement in meibomian gland function and mean reduction in dry eye symptoms, over 12 months. A single VTP treatment provides significantly greater mean improvement in meibomian gland function and dry eye symptoms as compared to a conventional, twice-daily, 3-month regimen. Early VTP intervention for meibomian gland dysfunction is associated with improved treatment outcomes.

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

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Figures

Figure 1

Figure 1

Abbreviated CONSORT flow diagram illustrating the subject disposition from enrollment through the completion of stage 2 of the study. Abbreviations: CC, completed cases; ITT, intention-to-treat; PP, per protocol; VTP, vectored thermal pulsation.

Figure 2

Figure 2

Mean MGS score over time for the 12-month cohort of eyes that received a single vectored thermal pulsation treatment. Note: Error bars represent standard deviation. Abbreviations: M, months; MGS, meibomian gland secretion.

Figure 3

Figure 3

Mean OSDI score over time for 12-month cohort of eyes that received a single vectored thermal pulsation treatment. Note: Error bars represent standard deviation. Abbreviations: M, months; OSDI, Ocular Surface Disease Index.

Figure 4

Figure 4

Mean change in MGS score from baseline to 3 months for treatment group stratified by duration of dry eye or MGD diagnosis and duration of dry eye symptoms. Note: Error bars represent standard deviation. Abbreviations: M, months; MGD, meibomian gland dysfunction; MGS, meibomian gland secretion.

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