Optometry and vision science : official publication of the American Academy of Optometry · 2025
Durability of the TearCare treatment effect in subjects with dry eye disease: Stage 3 of the Sahara randomized controlled trial.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Hovanesian John, Ayres Brandon D, Bloomenstein Marc R, Loh Jennifer, Chester Thomas, Saenz Bobby, Echegoyen Julio, Kannarr Shane R, Rodriguez Tomasita C, Dickerson Jaime E
Аннотация
SIGNIFICANCE: Localized 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.
METHODS: Subjects 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.
RESULTS: One 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.
CONCLUSIONS: Localized 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.
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.
METHODS: Subjects 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.
RESULTS: One 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.
CONCLUSIONS: Localized 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.