Clinical Efficacy of Hormone Replacement Therapy in Treating Perimenopausal Women With MGD
- Conditions
- Meibomian Gland Dysfunction
- Interventions
- Drug: Hormone replacement therapy
- Registration Number
- NCT04962386
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Brief Summary
This project aims to evaluate the possible relationship between MGD and HRT in perimenopausal women
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 30
- Perimenopausal women who did not undergo HRT
-
(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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Perimenopausal women who did not undergo HRT Hormone replacement therapy Perimenopausal women who did not undergo HRT at baseline. And they did not receive any other drugs Perimenopausal women who did undergo HRT 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.
- Primary Outcome Measures
Name Time Method Tear secretion 3 months 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.
- Secondary Outcome Measures
Name Time Method The scoring of corneal fluorescein staining 3 months 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.
Noninvasive tear break-up time test (NITBUT) 3 months 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.
Trial Locations
- Locations (2)
Hangzhou Obstetrics and Gynecology Hospital
🇨🇳Hangzhou, Zhejiang, China
Second Affiliated Hospital of Zhejiang University Hospital
🇨🇳Hangzhou, China