An observational study in Meibomian Gland Dysfunction, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Status unknown at 2 sites in China. Open to female participants aged 25 Years to 45 Years. Per ClinicalTrials.gov, last updated 2021-09-13.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational
This project aims to evaluate the possible relationship between MGD and HRT in perimenopausal women
This project aims to: 1. Evaluate the possible relationship between MGD and HRT in perimenopausal women; 2. To explore the mechanism of HRT treatment on MGD through clinical trials;3. Optimize treatment methods by exploring the mechanism, and develop more personalized and systematic treatment plans for MDG patients in the perimenopausal period.
168 studies on the registry are indexed under Meibomian Gland Dysfunction; 21 are open to participants now.
This study's planned enrollment of 30 is below the median of 80 across 21 observational studies indexed under Meibomian Gland Dysfunction.
Browse Meibomian Gland Dysfunction studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
Counted across the registry records on this site, refreshed daily.
MGD is a relatively new field of research in ophthalmology, so it has not been extensively studied up to now. However, MGD is believed to be a major cause of DE disease worldwide. It is estimated that MGD accounts for more than two-thirds of all DE cases. In one study, MGD accounted for 78 % of DE patients. The estimated incidence of MGD in Asian adults over 40 years of age ranges from 46.2% to 69.3%. Previous studies have shown that the production and stability of tears in postmenopausal women are reduced, and hormone replacement therapy can restore SLT values to the normal range. However, some studies have reported that women who receive HRT have a higher mortality rate than women who do not.
Exclusion Criteria:
(1) Patients who meet any of the following criteria will not be eligible for inclusion in the study: ① Unable or unwilling to sign a consent form, or unable to follow study procedures.
(2) Have worn contact lenses in the past month, have had anterior segment surgery in the past 3 months, have a history of corneal refractive surgery, and have eye diseases other than dry eyes.Use of topical medicines other than eye lubricants in the past 3 months.Use of total body immunomodulators, tetracycline, or glucocorticoids in the past 3 months.Occlusion of lacrimal dots or eye trauma in the past 3 months.③ is pregnant, nursing or breastfeeding, or has received HRT treatment.
④ All patients with DE related diseases, such as diabetes mellitus, Sjogren syndrome, Stevens-Johnson syndrome.All participants were free of cancer, liver disease, kidney disease, stroke, transient cerebral ischemia, myocardial infarction, peptic ulcer, gout, or mental illness.Women who used anticoagulants, corticosteroids or vitamin A, vitamin E or beta-carotene were also excluded.
Perimenopausal women who did not undergo HRT at baseline. And they did not receive any other drugs
Drug: Hormone replacement therapy
Perimenopausal women who did undergo HRT received estrogen-progesterone combination therapy packaged with estradiol tablets/estradiol and dynamic progesterone (Abbott Health Products BV. Weesp, The Netherlands).Take this medicine once a day. A course of treatment was defined as 28 days of continuous treatment.
Drug: Hormone replacement therapy
HRT women were treated with an estrogen-progesterone combination therapy packaged with estradiol tablets/estradiol and dynamic progesterone (Abbott Health Products BV, Weesp, the Netherlands).Take this medicine once a day.A course of treatment was defined as 28 days of continuous treatment.One white tablet containing 1mg of estradiol was taken daily for the first 14 days and one gray tablet containing 1mg of estradiol and 10 mg of dynamic progesterone was taken daily for the remaining 14 days.
Also known as: Received estrogen-progesterone combination therapy packaged with estradiol tablets/estradiol and dynamic progesterone (Abbott Health Products BV, Weesp, The Netherlands)
Tear secretion
After local anesthesia, a 35mm×5mm filter paper strip was placed longitudinally into the conjunctival sac of the lower eyelid. After 5 minutes, the length of the moist part was recorded. Less than 10mm was considered abnormal.
Time frame: 3 months
Noninvasive tear break-up time test (NITBUT)
After fluorescein staining, patients were asked to close their eyes and measure the time until the first tear film break point appeared.The average of the three measurements was recorded and was considered abnormal for less than 10 seconds.
Time frame: 3 months
The scoring of corneal fluorescein staining
The cornea was divided into two groups on average. After staining, the upper, middle and lower corneal sites were recorded and the scores of each site were recorded.0= no punctate staining;1= less than half staining: 2= more than half staining;3= total staining;And the cumulative score (0-9 points) for each quadrant.CFS was assessed at each follow-up.
Time frame: 3 months
Plan to share: No
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This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital, School of Medicine, Zhejiang University