Trial reportOptometry and vision science : official publication of the American Academy of Optometry2025
Durability of the TearCare treatment effect in subjects with dry eye disease: Stage 3 of the Sahara randomized controlled trial.
Trial report in Optometry and vision science : official publication of the American Academy of Optometry, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Corrections and comments
- Erratum issued
Authors and funding
10 authors.
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Abstract
significanceLocalized heat therapy with manual expression has been effective for meibomian gland dysfunction-associated dry eye disease in clinical studies including two randomized controlled trials, and in the present report, provides long-lasting relief from signs and symptoms for moderate-to-severe dry eye disease associated with meibomian gland dysfunction. PURPOSE: Meibomian gland dysfunction is a disease with high prevalence and accounts for most dry eye disease. Localized heat therapy with manual expression, an office-based intervention, has demonstrated effectiveness in improving the signs and symptoms of dry eye disease. The aim of this third phase of the Sahara randomized controlled trial was to study the durability of the treatment benefits.
methodsSubjects randomized to localized heat therapy in Sahara and receiving second treatment at month 5 continued follow-up for an additional 19 months. Ocular signs including tear break-up time and meibomian gland secretion score, and symptoms including ocular surface disease index were assessed at months 6, 9, 12, 15, 18, and 24. Subjects could be retreated when tear break-up time was within 2 seconds of study baseline and ocular surface disease index increased by 15 points from the previous visit.
resultsOne hundred sixty-six subjects entered this phase of the study. All measures of signs and symptoms (for the overall group of subjects) remained statistically significantly better than study baseline at all time points. Thirty-two subjects required additional treatment. Median time for retreatment was 8 months. Six-month retreatment-free survival probability was 92%. There were a few adverse events and none related to the localized heat therapy procedure.
conclusionsLocalized heat therapy with manual expression has been shown to be an effective treatment for meibomian gland dysfunction, providing durable relief from dry eye disease signs and symptoms. Treatment twice per year can provide meaningful improvement and symptomatic relief for patients with moderate-to-severe dry eye disease.
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