Clinical trial NCT04962386: Clinical Efficacy of Hormone Replacement Therapy in Treating Perimenopausal Women With MGD
Official title: Clinical Efficacy of Hormone Replacement Therapy in Treating Perimenopausal Women With Meibomian Gland Dysfunction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Meibomian Gland Dysfunction
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 30
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: Inclusion Criteria:

* Perimenopausal women who did not undergo HRT

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.

Primary outcomes:
measure: Tear secretion
timeFrame: 3 months
Secondary outcomes:
measure: Noninvasive tear break-up time test (NITBUT)
timeFrame: 3 months
measure: The scoring of corneal fluorescein staining
timeFrame: 3 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou Obstetrics and Gynecology Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Second Affiliated Hospital of Zhejiang University Hospital
Study officials:
affiliation: Second Affiliated Hospital of Zhejiang University Hospital
name: Jin x ming, phd
role: STUDY_DIRECTOR
References: