TearCare for the Treatment of Meibomian Gland Dysfunction in Adult Patients With Dry Eye Disease: A Masked Randomized Controlled Trial
Autor: | Edward J. Holland, John A. Hovanesian, Preeya K. Gupta, Paul M. Karpecki, Kavita Dhamdhere, Jennifer Loh, Mitchell A Jackson |
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Rok vydání: | 2021 |
Předmět: |
Adult
Male medicine.medical_specialty Meibomian gland Disease law.invention Double-Blind Method Randomized controlled trial law Surveys and Questionnaires Ophthalmology medicine Humans Ocular Surface Disease Index Prospective Studies Blepharitis Adverse effect Meibomian Gland Dysfunction Aged business.industry Meibomian gland dysfunction Hyperthermia Induced Middle Aged medicine.disease eye diseases Treatment Outcome medicine.anatomical_structure Tears Chalazion Dry Eye Syndromes Female sense organs business Follow-Up Studies |
Zdroj: | Cornea. 41:417-426 |
ISSN: | 0277-3740 |
Popis: | PURPOSE The aim of this study was to demonstrate the safety and effectiveness of a single TearCare procedure compared with a single LipiFlow procedure in treatment of the dry eye disease associated with meibomian gland dysfunction. METHODS In a multicenter, masked, randomized controlled trial, 135 subjects received a single TearCare (TC) treatment (n = 67) or a single LipiFlow (LF) treatment (n = 68) at baseline and were followed up for 1 month posttreatment. Tear film breakup time, meibomian gland function, and corneal and conjunctival staining scores were assessed as dry eye signs at baseline, 2 weeks, and 1 month; dry eye symptoms were assessed using the Ocular Surface Disease Index, Symptom Assessment in Dry Eye, and eye dryness questionnaires at baseline and 1 month. RESULTS At 1 month posttreatment, both groups demonstrated significant improvements (P < 0.0001) in mean tear film breakup time and meibomian gland secretion score to 3.0 ± 4.4 and 11.2 ± 11.1 in the TC group and 2.6 ± 3.3 and 11.0 ± 10.4 in the LF group, respectively. The mean eye dryness, Symptom Assessment in Dry Eye, and Ocular Surface Disease Index scores were significantly reduced (P < 0.0001) by 35.4 ± 34.1, 38.2 ± 31.0, and 27.9 ± 20.5 in the TC group and 34.9 ± 26.9, 38.0 ± 25.9, and 23.4 ± 17.7 in the LF group, respectively. There were no statistically significant differences for any result between the groups. However, the TC group demonstrated numerically greater improvements consistently in all signs and symptoms. Device-related ocular adverse events were reported in 3 patients in the TC group (superficial punctate keratitis, chalazion, and blepharitis) and 4 patients in the LF group (blepharitis, 2 cases of foreign body sensation, and severe eye dryness). CONCLUSIONS A single TearCare treatment significantly alleviates the signs and symptoms of dry eye disease in patients with meibomian gland dysfunction and is equivalent in its safety and effectiveness profile to LipiFlow treatment as shown in this 1-month follow-up study. |
Databáze: | OpenAIRE |
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