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M. A. Lemp, L. Bardfield, C. A. Blackie, H. P. Saras, S. Grenon, J. Hutchinson, B. Gravely, T. Douglass, D. R. Korb; Evaluation of a Novel Method of Treatment of Dry Eye. Invest. Ophthalmol. Vis. Sci. 2008;49(13):127.
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© ARVO (1962-2015); The Authors (2016-present)
To assess the safety and efficacy of a new device to treat meibomian gland dysfunction.
15 patients (age range 18 - 77) with dry eye symptoms and meibomian gland dysfunction (MGD) were enrolled from a clinical site in the British West Indies. Patients received an initial exam to establish eligibility after informed consent was obtained. The patients were treated with a novel application of thermodynamic energy to induce lipid gland regenesis to open and reactivate the meibomian glands. The patients were requested to return for follow-up visits at 1-week, 1-month, 3-months and 1-year post-treatment. At each visit, patients reported their symptoms (subjective SPEED questionnaire, had to score at least 6 points to qualify. Symptom scores = 5-9 are moderate, scores = 10 or greater are severe. Evaluation of efficacy parameters included: fluorescein break-up time (FBUT), lipid layer thickness (LLT, interferometry), and the number of lower lid meibomian glands yielding liquid secretion when expressed with a custom research device.
Of the 15 patients, 12 returned for the 3-month visit and 8 patients returned for the 1-year visit. There were no adverse events from the treatment. The mean symptom score for the 15 subjects enrolled was 15.4 ± 2.8. For the 8 subjects that completed the study through 1 year: symptoms decreased from 12.9 ± 2.5 pre-treatment to 3.25 ± 1.7 at 1 month, 2.25 ± 1.3 at 3 months, and 1.0 ± 0.5 at 1 year (p < 0.0001). LLT increased from ~ 60 nm (thin; 61.9 ± 8.7 nm) to ~ 105 nm (thick and adequate; 110.7 ± 21.9 nm) at 1 month and remained above 90 nm (99.4 ± 16.9 nm) at 1 year (p = 0.043). The number of lower lid meibomian glands yielding liquid secretion increased from 5.6 ± 1 to 10.9 ± 1.7 at 1 month, 13.8 ± 1.0 at 3 months and declining to 6.9 ± 0.8 at 1 year (p < 0.0001). Tear break up time increased from 5 ± 0.6 s to 6 ± 0.5 s at 3 months and decreased back to 5 ± 0.8 s at 1 year (p = 0.27).
The application of this novel method to treat MGD was found, in this study, to be successful for the alleviation of symptoms, increasing LLT, and restoring the ability of the meibomian glands to secrete.
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