Clinical Trials Directory

Trials / Completed

CompletedNCT05920655

Comparison of Ocular Changes by Surgical Menopause Using Optical Coherence Tomography (OCT)

Status
Completed
Phase
Study type
Observational
Enrollment
100 (actual)
Sponsor
Batman Training and Research Hospital · Other Government
Sex
Female
Age
30 Years – 55 Years
Healthy volunteers
Accepted

Summary

The aim of this study is to investigate the early changes in macular thickness, corneal thickness and intraocular pressure in young women undergoing surgical menopause. Methods: Eye findings of 30 surgical menopausal (Postoperative 3-6 months) and 48 natural menopause and 22 healty women (control) were evaluated using OCT. Women with no known eye disease, no chronic disease (Diabetes Mellitus, Cardiac Disease any Autoimmune disease) and no migraine in addition to non smokers were included in the study. Women using any hormone and obese women ( BMI \>25 kg/m2) were excluded. Macular and corneal thickness and intraocular pressure (IOP) were measured in both eyes of the women

Detailed description

This prospective case control study was conducted in a tertiary gynecology and obstetrics clinic and eye clinic between 2020 and 2021 with ethics committee approval number 2020 250 ). Informed consent form was obtained from all participants. All participants were outpatients who applied to obstetrics clinic in Batman Training and Research Hospital. The study started with 105 patient. Based on the study exclusion criteria, 7 patients were excluded from the study. Every patient in the surgical menopause group underwent a hysterectomy and bilateral salpingo-oophorectomy for benign uterine reasons. The patients included in the study were menstruating women with preoperative natural ovarian appearance and benign non ovarian indications, who had undergone hysterectomy and bilateral salpingo-oophorectomy and had no preoperative menopause complaints. Patients younger than 52 years of age who have undergone oophorectomy are patients whose ovaries have been removed either because of patient anxiety due to a family history of cancer or because of adhesions.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTOptic coherence tomographyEye examination of patients with optic coherence tomography test by an ophthalmologist

Timeline

Start date
2022-02-12
Primary completion
2023-06-01
Completion
2023-06-15
First posted
2023-06-27
Last updated
2023-06-27

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT05920655. Inclusion in this directory is not an endorsement.