Androgen Deficiency, Ocular Surface Disease, Tear Osmolarity
Conditions
Keywords
androgen deficiency, ocular surface, tear osmolarity
Brief 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.
Interventions
DRUGandrogen replacement therapy
intramuscular testosterone
Sponsors
Neon Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Androgen deficiency
Exclusion criteria
* having any ocular disease, history of surgery, drop use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tear Osmolarity in mOsm/L | 5 months | Tear osmolarity was measured by TearLab device in patients. The changes in the tear osmolarity 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. |
| Schirmer Test in mm | 5 months | Schirmer Test is applied by Schirmer tear paper after anesthesic drop administration into the eye. |
| Tear break-up time (TBUT) in sec | 5 months | TBUT is measured by ophthalmologist after application of fluorecein dye. |
| MGD-GS score in number | 5 months | MGD-GS score was performed by ophthalmolgist using biomicroscopy |
| Questionary Scoring in number | 5 months | AMS and OSDI scoring charts were completed by the participants. |
| Optical Coherence Tomography findings: TMH, TMA, and TMD in microns | 5 months | Tear meniscus height (TMH), area (TMA), and depth (TMD) were measured by Optical coherence tomography in each participants. |
Countries
Turkey (Türkiye)
Outcome results
None listed