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Objective: To evaluate tear osmolarity and ocular surface findings in men with androgen deficiency (AD) and assess changes after androgen replacement therapy (ART). Design: A prospective interventional study. Participants and Methods Right eyes of 77 male participants were evaluated in this study. Serum total testosterone level were measured, and participants were categorized as AD group (testicular hypofunction, n=37, testosterone level \<231 ng/dL) and control group (healthy controls, n=40, testosterone level \>346 ng/dL). The parameters including Aging Male Symptoms Scale(AMS), OSDI scores, Meibomian Gland Dysfunction- Grading System(MGD-GS) scores, corneal staining, tear break-up time(TBUT), Schirmer I/II tests, tear osmolarity, the depth (TMD), the height (TMH) and the area (TMA) of inferior tear meniscus were investigated. AD group received intramuscular testosterone every two weeks. Main Outcome Measures: The changes in the ocular surface parameters were investigated during the ART while comparing the values of these parameters between the AD and control groups at baseline, 6th and 18th weeks of the treatment.
Age
18 - 75 years
Sex
MALE
Healthy Volunteers
No
Ondokuz Mayıs University
Samsun, Atakum, Turkey (Türkiye)
Start Date
January 1, 2020
Primary Completion Date
August 30, 2020
Completion Date
June 15, 2025
Last Updated
September 11, 2025
77
ACTUAL participants
androgen replacement therapy
DRUG
Lead Sponsor
Neon Hospital
NCT04354545
NCT06555367
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View ClinicalTrials.gov Terms and ConditionsNCT04895306