Clinical trial NCT05920655: Comparison of Ocular Changes by Surgical Menopause Using Optical Coherence Tomography (OCT)
Official title: Comparison of Ocular Changes by Surgical Menopause Using Optical Coherence Tomography (OCT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corneal Deformity
Macular Degeneration Advanced
Surgical Menopause
Lead sponsor: Batman Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-06-27
Enrollment: 100
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient selection was made between surgical menopause, natural menopause and healthy women who have given birth before.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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-oopherectomy, 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.
* having a healthy child
* have consented to participate in the study

Exclusion Criteria:

* Chronic disease (such as diabetes, heart disease)
* History of continuous drug use
* Unwillingness to participate in the study Being between the ages of 18-30

Primary outcomes:
measure: Effect of surgical menopause on corneal and macular thickness
timeFrame: 6 months after hysterectomy and bilateral salpingo-oopherectomy
Secondary outcomes:
measure: Eye examination needed after surgical menopause
timeFrame: 6-12 months
Other outcomes:
Locations:
city: Batman
country: Turkey
facility: Batman education adn research hospital
Study officials:
affiliation: Batman Training and Research Hospital
name: Erhan Okuyan
role: PRINCIPAL_INVESTIGATOR
References: