NCT07168265

The Effects of Androgen Replacement Therapy on Tear Osmolarity and Ocular Surface Parameters in Androgen Deficiency

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Neon Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Androgen Deficiency
• Ocular Surface Disease
• Tear Osmolarity

Interventions

Type	Name	Description
DRUG	androgen replacement therapy	intramuscular testosterone

Timeline

• Start date: 2020-01-01
• Primary completion: 2020-08-30
• Completion: 2025-06-15
• First posted: 2025-09-11
• Last updated: 2025-09-11

Locations

1 site across 1 country: Turkey (Türkiye)