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Completed

NCT Number: NCT05920655

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

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

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Key information

Age range

30 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Batman education adn research hospital

Batman, 72100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Optic coherence tomography

Diagnostic Test

Eye examination of patients with optic coherence tomography test by an ophthalmologist

Primary outcomes

  1. Effect of surgical menopause on corneal and macular thickness

    Time frame: 6 months after hysterectomy and bilateral salpingo-oopherectomy

    To question the effect on macular and corneal thickness secondary to sudden ovarian hormone change with surgical menopause.

Secondary outcomes

  1. Eye examination needed after surgical menopause

    Time frame: 6-12 months

    To seek an answer to the question of adding eye diseases examination to the examinations of post-surgical menopause patients.

Sponsors and collaborators

Lead sponsor

Batman Training and Research Hospital

Other Gov

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 27, 2023
Registry last updated
Jun 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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