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

Neon Hospital

Status: Completed

Conditions: Tear Osmolarity; Androgen Deficiency; Ocular Surface Disease

Treatments: Drug: androgen replacement therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07168265

OMU

OMU KAEK 2021/557

Details and patient eligibility

About

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.

Enrollment: 77 patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Androgen deficiency

Exclusion criteria

• having any ocular disease, history of surgery, drop use

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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77 participants in 1 patient group

testosterone

Other group

Treatment:

Drug: androgen replacement therapy