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IRCT20201219049753N1 IRCT 2020-12-26 Mashhad University of Medical Sciences Effect of Tea tree oil in treatment of Meibomian gland dysfunction Comparison of the effect of Tea tree oil with baby shampoo in Meibomian gland dysfunction treatment 2014-04-05 anticipated 40 Complete https://irct.ir/trial/53077 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients received baby or TTO shampoo for each eye randomly based on the simple random sampling method. Two boxes were labeled with A and B by the manufacturer. In each box we had containers with same solution (TTO or baby shampoo). For each patient, A and B was determined by lot for the eyes, Blinding description: Physician was unaware of the contents of the containers. Physician was researcher, outcome assessor and data analyst. Shampoos were slightly different in color, consistency and odor and could not be completely simulated. The patient was aware that two different solutions were prescribed for rinsing the eyes but he/she did not know which solution was used for which eye. 3 Meibomian gland dysfunction. Intervention 1: Intervention group 1: Ophthalmic cleansing shampoo containing TTO (EYESOL), once a day, for three months. After washing hands, a cotton bud was to be moistened with the solution. Then, with the index finger of the other hand, he/she must gently hold down the lower eyelid and look up. Eyelashes and eyelid margin were to be rubbed gently with the bud for 60–90s. Afterwards, he/she must gently hold up the upper eyelid and look down and rub upper eyelid margin. After each application, eyes and eyelids were to be rinsed thoroughly with clean water. Intervention 2: Intervention group 2: JOHNSON'S® baby shampoo, once a day, for three months. After washing hands, a cotton bud was to be moistened with the solution. Then, with the index finger of the other hand, he/she must gently hold down the lower eyelid and look up. Eyelashes and eyelid margin were to be rubbed gently with the bud for 60–90s. Afterwards, he/she must gently hold up the upper eyelid and look down and rub upper eyelid margin. After each application, eyes and eyelids were to be rinsed thoroughly with clean water. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals. When: The start of the access period is after the results are published. To whom: Researchers working in academic and scientific institutions can have access. Conditions: They can use the data to get acquainted with the type of data classification and statistical analysis. Where to obtain: Sending an email to the researcher in charge of the study zamanigh@mums.ac.ir How to obtain: The request will be sent via an email to the researcher in charge of studying, and after reviewing the request by the research team and final approval, the data will be sent within a month. Comments:
public Ghodsieh Zamani
Khatam Al-Anbia Eye Hospital, Aboutaleb Intersection
Mashhad Iran (Islamic Republic of) 9195965919 +98 51 3728 9911 Zamanigh@mums.ac.ir Mashhad University of Medical Sciences scientific Ghodsieh Zamani
Khatam Al-Anbia Eye Hospital, Aboutaleb Intersection
Mashhad Iran (Islamic Republic of) 9195965919 +98 51 3728 9911 Zamanigh@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Adult patients aged 18 to 70 years with meibomian gland dysfunction diagnosis in slit-lamp examination 18 years 70 years Both Systemic medications affecting tear production (antihistamines, antidepressants and etc.) Contact lenses Eyelid malfunction such as lagophthalmous History of ocular surgery Other ocular diseases involving ocular surface (Stevens-Johnson, Sjogren's syndrome, chemical damage, history of head radiation) Systemic diseases involving ocular surface ( Diabetes mellitus, rosacea, neurologic diseases) Infectious keratoconjunctivitis Any topical medication such as steroids during last four weeks H02.88 Meibomian gland dysfunction of eyelid Treatment - Drugs Treatment - Drugs Intervention group 1: Ophthalmic cleansing shampoo containing TTO (EYESOL), once a day, for three months. After washing hands, a cotton bud was to be moistened with the solution. Then, with the index finger of the other hand, he/she must gently hold down the lower eyelid and look up. Eyelashes and eyelid margin were to be rubbed gently with the bud for 60–90s. Afterwards, he/she must gently hold up the upper eyelid and look down and rub upper eyelid margin. After each application, eyes and eyelids were to be rinsed thoroughly with clean water. Intervention group 2: JOHNSON'S® baby shampoo, once a day, for three months. After washing hands, a cotton bud was to be moistened with the solution. Then, with the index finger of the other hand, he/she must gently hold down the lower eyelid and look up. Eyelashes and eyelid margin were to be rubbed gently with the bud for 60–90s. Afterwards, he/she must gently hold up the upper eyelid and look down and rub upper eyelid margin. After each application, eyes and eyelids were to be rinsed thoroughly with clean water. Ocular surface symptoms score in DEQ5 questionnair. Timepoint: At first (before treatment), one and three months after treatment. Method of measurement: DEQ5 questionnair. Conjunctival redness. Timepoint: At first (before treatment), one and three months after treatment. Method of measurement: Conjunctival vessel dilation and hyperemia. Fluorescein staining of the cornea and conjunctiva. Timepoint: At first (before treatment), one and three months after treatment. Method of measurement: Oxford scoring system after fluorescein staining. Tear break up time in second. Timepoint: At first (before treatment), one and three months after treatment. Method of measurement: After applying fluorescein dye, the patient blinks several times and then we ask her/him not to blink anymore. We record the time of the first dark spot in the tear on the surface of the cornea in seconds. Lid margin vascularity. Timepoint: At first (before treatment), one and three months after treatment. Method of measurement: Existence of telangiectasia at the edge of the eyelid on slit lamp examination. Plugging of meibomian gland orifices. Timepoint: At first (before treatment), one and three months after treatment. Method of measurement: Existence of elevation of meibomian gland orifices in slitlamp examination. Capping of meibomian gland orifices. Timepoint: At first (before treatment), one and three months after treatment. Method of measurement: Existence of oil droplets on lid margin. Tear production in the Schirmer1 test. Timepoint: At first (before treatment), one and three months after treatment. Method of measurement: Wetting of the Shermer strip in millimeters after 5 minutes in the lower fornix between the inner two-thirds and the outer third (with out topical anesthetic). Meibomian gland expressibility. Timepoint: At first (before treatment), one and three months after treatment. Method of measurement: It was determined by simultaneous expression from approximately eight glands (occupying central one third of the lower lid length) by firm digital pressure. It was scored according to the number of the eight glands from which a fluid secretion can be expressed, regardless of its qualitative appearance (0 = all glands expressible, 1 = 3–4 glands expressible, 2 = 1–2 glands expressible, 3 = no glands expressible). Meibum quality. Timepoint: At first (before treatment), one and three months after treatment. Method of measurement: Quality of expressed lipid was evaluated in appearance and scored as follows; clear fluid (0), cloudy fluid (1), viscous fluid containing particulate matter (2) and densely opaque, inspissated, toothpaste-like material (3). Meibum quality score was defined by summation of scores of expressed glands. Occurrence of possible side effects. Timepoint: At first (before treatment), one and three months after treatment. Method of measurement: Occurrence of itching, burning, redness and irritating symptoms of eyes and eyelid skin after starting treatment. Mashhad University of Medical Sciences Approved 2014-03-15 •Ethics committee of Mashhad University of Medical Sciences Ethics committee, Medical sciences faculty, Pardis, Vakil abad blvd. Mashhad Razavi Khorasan Iran (Islamic Republic of)