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Clinical Efficacy of Hormone Replacement Therapy in Treating Perimenopausal Women With MGD

Clinical Efficacy of Hormone Replacement Therapy in Treating Perimenopausal Women With Meibomian Gland Dysfunction

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04962386
Enrollment
30
Registered
2021-07-15
Start date
2019-03-06
Completion date
2022-03-06
Last updated
2021-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meibomian Gland Dysfunction

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.

Interventions

DRUGHormone 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.

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 45 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Tear secretion3 monthsAfter 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

MeasureTime frameDescription
Noninvasive tear break-up time test (NITBUT)3 monthsAfter 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.
The scoring of corneal fluorescein staining3 monthsThe 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.

Countries

China

Contacts

Primary Contactjin x ming, phd
18757163724@163.com18757163724
Backup Contactqin qi yu, md
18344980414@163.com18344980414

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026